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tv   Administration Officials Testify on Efforts to Regulate Fentanyl- Related...  CSPAN  January 12, 2022 5:53pm-8:52pm EST

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>> a look now at efforts to have sentinel-related from substances with the u.s. drug enforcement agency. >> good morning, everyone. the subcommittee health will now come to order. due to covid-19 today's hearing will be held remotely as well as in person. for members and witnesses taking
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part in person we are following the guidance of the cdc and the office of the attending physician so please wear a mask when you're not speaking. for members and witnesses taking part remotely, microphones will be set on mute to eliminate background noise. members and witnesses, you will need to unmute your microphone when you wish to speak. since members are participating from different locations at today's hearing recognition for members for questions will be in the order of subcommittee and seniority. documents should be sent to megan mullen at the e-mail we provided to your staff. all documents will be entered into the record at the conclusion of our hearing. >> the chair now recognizes herself for five minutes for an opening statementa our country has grappled with the public health crisis caused by a novel
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virus for nearly two years now, we also faced a more familiar threat in the form of drug addiction. more than $100,000 americans have died. let me repeat that. more than 100,000 americans have died of drug overdoses since the covid-19 pandemic began. a grim record that shows no sign of abating. the fastest growing cause of overdose deaths has been synthetic opioids including fentanyl. since 2018 all fentanyl-related substances that are not already scheduled that been listed under the substances control act and they will expire at the end of -- i think at the end of january. the continuing resolution introduced this morning extends the deadline it february 18th. despite this temporary
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scheduling, deaths due to fentanyl-related overdoses have continued to rise even as deaths caused by other drugs have fallen. our subcommittee hearing today is to learn from the administration its recommendations for congress for permanent scheduling of all fentanyl-related substances. the interagency proposal calls for permanently scheduling these drugs under schedule one, but with an expedited process to reschedule those that are later found not to be dangerous enough to warrant regulation. over 100 civil rights groups have expressed concern because it expands the drugs subject to mandatory minimum sentences that contribute to the disproportionate incarceration of racial minorities. to address this children, mandatory minimums would not apply in most cases involving
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fentanyl-related substances unless there is death or serious bodily harm and if a substance is later removed from schedule one, incarcerated individuals could have their sentences redued or vacated. the proposal would make it easier for researchers to get permission from the federal government to study all schedule 1 substances. the current restrictions deter many researchers from studying these drugs and removing some of these barriers will help us better understand how to treat addiction. today we will hear from some of the agencies that developed these recommendations including the fda, the national institute on drug enforcement administration and the office of national drug control policy and we look forward to their insights on how the administration's proposals will help address the overdose
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epidemic. i want all members to know that we invited the department of justice, the doj to testify, but they chose not to appear at today's hearing. our staff began conversations with the doj about the hearing last september and i formally invited them to send a witness on november 18th. doj's refusal to testify, i find to be troubling, and they offered no legitimate reason. they just declined their perspective on their own recommendations to congress would have been valuable for us to hear. so now the chair is pleased to recognize the distinguished member of the subcommittee, mr. guthrie, for his opening statement. >> thank you, chair eschu for
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holding this important hearing. how to combat the trafficking of fentanyl-related substances. this committee has a bipartisan history of addressing the opioid epidemic. for example, the support for patients and communities act included in my bill the comprehensive act, with the recovery centers throughout the nation. these centers provide evidence-based comprehensive care with those with substance use disorders. i'm frustrated and pleased to see that we will move forward with scheduling of february the 18th and i am frustrated that we've failed to come up with and join together. we lost 100,000 americans last year to drug overdoses in my home state of kentucky, overdose deaths were by 54%. the policy described the trend
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as one of the critical public health and safety issues facing kentucky. additionally, the agency attributed most of these deaths to fentanyl and fentanyl analogs which the 2020 fatality reports that it was over 70% of the commonwealth overdoses in 2020. these aren't just numbers on a page. they're mothers, brothers, fathers, sisters and friends and children. in march of this year, a kentucky mother purchased drugs laced with fentanyl and not too long after found her 2-year-old son dad after he reached into her purse while she was napping and ingested the deadly poison. these tragedies have become all too familiar with 2,000 americans across the country. health care closures have also caused disruptions and lengthy delays who are seeking justice
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order treatment. these delays have also affected those seeking first-time care for disorders and have tragically led to sharp increase in overdoses. i worry about the workforce shortages exacerbated by vaccine mandates. the health care heroes though i am vaccinated and encourage those to do so. even worse, the biden's board crisis has essentially made kentucky and every other state a border state. only two milligrams of fentanyl can be a lethal dose. in the u.s. customs and border protection has reported that almost 4,000 pounds of fentanyl stays at the southern border. the drug administration's own leadership cited statistics sees that this past year alone to give every american a lethal
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dose. the biden administration drives increases in drug overdoses. i had been urging my colleagues by supporting the federal initiative by targeting fentanyl act. although the administration had permanently scheduled these substances, the proposal misses the mark to impose mandatory minimum on traffickers by excluding mandatory minimum for trafficking fentanyl analog, the proposal effectively incentivizes the cartels to continue to develop more variations of fentanyl to our own backyards, given that fentanyl and its analogs have contributed to the highest levels of overdose rates that they've ever seen excluding them from the mandatory minimum is disturbing. it is unfortunately that the department of defense and the department of justice can't be here today to explain this policy. if the doj refused to show up to
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today's hearing because they are unable to justify the policies in this proposal? why didn't the administration send their top federal law enforcement in the agency to share their plans with the american people on how they'll get the deadly poisons off our street. i appreciate the chair's remarks because it is important that they're not here. it is their job. i know sometimes hearings aren't convenient for people to appear, and it is our job for oversight and their job to be here. i will continue to press fentanyl analogs and give law enforcement the resources needed to fight back against the illicit trafficking of fentanyl and fentanyl-related substances across the united states that are sadly taking the lives of thousands of americans. thank you. thank you, madam chair, and i yield back. >> the gentleman yields back. the chair is now pleased to recognize the chairman of the full committee, mr. polone for
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five minutes. >> thank you. we continue the work of combatting the drug overdose crisis. this crisis is a tragedy, taking americans far too soon during the first months of the covid pandemic. for years we've worked to combat this crisis. earlier this year as part of the american rescue plan we included $3 billion for the block grant programs as a substance abuse and mental health services administration. this funding was the largest aggregate amount of funding for the programs and it goes to critical programs and services to people experiencing substance use disorder. the american rescue plan builds upon the work we've done, but we obviously must do more. today we're discussing solutions to the overdose issue and fentanyl and fentanyl analogs
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have been the driver, this year, more than half of overdose deaths with synthetic drugs missed with synthetic i don't knowoids illicit fentanyl. it's dramatically increased and manufacturers have been able to evade regulations by rapidly regulating new versions of substances that aren't subject to control. today's fentanyl-related substances are in schedule one of the controlled substances act which is the strictest category of regulation. they have no accepted medical use and the high potential for abuse or lack of safety. schedule one prohibits the manufacturing distribution and let's give an explicit approval to do so. the current temporary orders suggesting federal related things and it's set to expire in zhan jan 28, 2022. >> we will consider this probably today will provide an
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extension through 10 feb of next year. it's important that they put in bliss a long-term, and fentanyl-related substances prepared by the office of national drug control policy, and the department of human health and human services and the department of justice and i appreciate you joining us today. there is a definition of fentanyl-related substances and permanently place them in schedule one. it would expedite scheduling or descheduling of substances as needed and i am pleased that it includes proposals to streamline registration and schedule one substances and the registration requirements more closely with schedule two requirements will help expedite registration with researchers and will expand further research in this space and development of future
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treatments. i look forward to learning more about the administration's proposal and why congress should pass legislation to reflect the recommendations. as we discuss this proposal it's important we remember that this is a set of recommendations. this committee is responsible for crafting the legislation of many americans. there are many ideas and proposals to meet this goal including strategies and harm reduction and recovery services. there is no idea too big or too small to solve this crisis and we can work together to solve it. i am pleased that dea is represented here by its principal deputy administrator, and i look forward to also working directly with doj with this committee's proposal so this committee can better understand the intent behind the policy recommendations related to enforcement. i look forward to hearing from our eyewitnesses and madam chair, i'm sure that this is
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something you're very concerned about and thank you for having this important hearing today. i yield back. >> the chairman yields back. the chair would recognize congress mcmorris rogers. she's a distinguished ranking member of our full committee for five minutes for an opening statement. thank you, madam chair. >> fentanyl and fentanyl-related substances are killing a record number of americans. making sure that these deadly poisons are permanently made illegal requires urgent action. lives are on the line. an unthinkable amount of fentanyl and analogs are coming across our border enough to kill every american seven times order. according to the cdc national health statistics there were over 100,000 drug overdoses in april 2020 to 2021. in my home state of washington, the overdose death rate increased by more than 36%, it's
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higher than the national average all because fentanyl and its many analogs and here are the many analogs, death and killing rise in spokane, and a reported increase in fentanyl overdoses. i wanted to share a story about my community where in spokane the u.s. drug market is completely bulthsed a dukz and despir when he had a child and unfortunate he, overdosed on heroin. the paramedicsed ministered nafk an ask woke up in the ambulance. he later learned what he consumed it was laced with fentanyl. every time he uses he's playing russian rule eat offet, and the dea has seen a record -- they
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prescription pills have febt nil. more pills were found, two out of every five pills in a potential lethal use of fentanyl. this is not a street drug and it is a weapons-grade poison that is killing children. >> kayla, she and her friend split what she thought was a percocet tablet. that one pill which was laced with fentanyl immediately killed them both. they had no chance. for people like allen and kayla, republicans have been trying to permanently place fentanyl related substances and we are from an army of parents and parents who deserve justice because they've lost a child and they don't want anyone else to experience their pain. the biden administration agrees
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that weigh should permanently schedule one and detect dangerous drugs bike fentanyl and treat those with substance use disorders. that's where we agree. unfortunately, the administration's also trying to treat these deadly poisons differently from fentanyl and other scheduled fentanyl analogs. they're trying to stop the class from tracking mandatory minimum. this would prevent our law enforcement from finding and putting away drug traffickers who are bringing together the chemical weapons across the border. for the parents we're fighting for it would mean criminals who killed their kids to keep trafficking these lethal substances with lower repercussions. surely, there is bipartisan support to deliver justice for these families. we should be working together to punish those who make, import and distribute these poisons to our children and help those with
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substance abuse disorders. congress has worked together on support for a patients and communities act. in addition to permanently scheduling fentanyl analogs i stand ready to re-authorize key programs that the substance abuse and mental health services administration that require next year. >> we need to take urgent actions on fentanyl analogs. it is tooed itly could be weak and even if congress passes the cr after today, fentanyl 18th, federal-related substances will remain legal, we will not tie law enforcement's hands to keep this poison out of our communities and simply kick the can another few months. congress needs to make permanent
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the fentanyl analog ban immediately along with existing criminal penalties. parents, communities and our constituents need it. with that, i yield back. >> the gentle woman yields back. i would like it advise members that pursuant to committee rules all members' written opening statements shall be made part of the record. i now would like to introduce our witnesses. mr. kemp chester is the assistant director of the office of national drug control policy and office of the president. welcome to you and thank you for being with us today. dr. nora volkov. she's the director of a national institute on drug abuse at the national institutes of health and we can say welcome back. you have graced the witness
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table several times before and we welcome you back. the deputy director for regulatory programs for drug evaluation and research at the fda. welcome to you and thank you for being with us and mr. lewis millioni is the principal deputy administrator of the drug enforcement administration, the dea. welcome to you and thank you for being here today. we look forward to the testimonies that you are going to provide to us. you're probably familiar with the light system. it isn't anything complex. you have one minute remaining when the yellow light comes on, and i think everyone knows what red means. mr. chester, you are now recognized for your five minutes of testimony and thank you again for being here with us today for this very important hearing.
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>> chairwoman, ranking member, thank you for inviting me to testify today. >> the biden-harris administration approaches america's overdose epidemic with the urgency it demands. with evidence-based drug approximately see that effectively has the public health dimension of the problem with the drug trafficking environment facing the united states and the world. at present, one of the complex and consequential challenges we face is illicitly manufactured fentanyl and frs. they confound our efforts to reduce opioid-related overdoses and deaths and it pervaded the nation's illicit drug supply around the country and are the main driver of the increase in drug poisoning deaths of the united states. in 2020 alone, overdose deaths involving synthetic opioids and primarily illicit fentanyl and its analogs by 55%.
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new and emerging frs are being manufactured faster than the united states can schedule them individuallies in estating it as a whole. it may be possible to synthesize as many as 4,800 fentanyl analogs with relatively simple modifications to the base fentanyl molecule. time is of the essence. although scheduling is not sufficient in itself to solve this problem, it is absolutely necessary to control substances yet to be made and yet to be made available in america's communities. we must deter the creation of these new substances and disrupt their flow into the united states in order to allow our historic investments of public health interventions to take hold and make tangible progress. for the past several months the office of national drug control policy and the department of justice and the department of health and human services to
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develop recommendations for a comprehensive, consensus approach that addresses the complex issues with frs. it involves input from the congress and public health officials and law enforcement partners and stake holder groups. these recommendations will permanently schedule these dangerous substances as a class while ensuring that access for scientific research is not burdensome and civil rights protections are safeguarded and this is a delicate balance and we sought to provide a responsible and comprehensive approach. >> the administration recommends the following. first, previously in accordance with the controlled substances act with the csa. >> second for these class scheduled frs with the mandatory minimum penalties associated with the domestic trafficking of schedule one substances. this exception does not apply
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where there is a direct link to death or serious bod low injury. third, create a streamline proddes is by hhs to remove or reschedule frs found not to have high potential for abuses defined in the csa. ensure a federal court is able to vacate and reduce the individual convicted of an offense involving an frs that is subsequently removed from schedule one. fifth, establish a simplified process including frs more closely with the research registration process for schedule 2 substances and finally, direct government accountability office for permanent class scheduling of frs including its impact on research, civil rights and the illicit manufacturing and the trafficking of these dangerous substances. these recommendations follow the approach outlined in the
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administration's first-year drug policy priorities which explains evidence-based prevention, harm reduction and recovery support services as well as reducing the supply of illicit drugs. the foundation of these recommendations rests with making our communities health wrer and safer without causing unintended harm. they are a critical part of our com pro hencive effort to reduce the use of negative consequences throughout the nation. on behalf of dr. gupta and the office of national drug control policy i would like to thank you and your congressional colleagues for your leadership and thank the federal partners for the close collaboration on this critical issue. i thank you for your time and i look forward to your questions. >> thank you very much. dr. volkov, you have five minutes for your testimony and we once again welcome you here
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today. >> good morning, chairwoman, ranking member guthrie and members of the subcommittee. thank you for inviting me to speak to you today. .nil substances are sparking a deep rise in the united states. the latest data show overdose deaths exceeded 100,000 in the year, a staggering figure and the highest number ever recorded in a 12-month period in the united states. overdose deaths increased by 49% during that period. therefore, we reduced trafficking and manufacture of these dangerous substances. however, these should not be done of criminal icing people, an approach that we know the little to deter drug use,
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substance abuse disorders. instead an evidence-based approach that prioritizes prevention and treatment of substance use disorders is needed to address the opioid and overdose prices. in these regards, we search on fentanyl-related substances and each to develop treatment of opioid addiction and overdose particularly in light of report that current medications may not be as effective against fentanyl. >> however, obtaining a dea registration with the fentanyl-related substances and other schedule one draws, and researchers report that obtaining and modifying a dea registration can take many months. the application process has the reviews needed to obtain a federal grant with an fda
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investigation of a new drug authorization. establishing that security infrastructure to conduct schedule one research, which is expensive, may need to be duplicated for each registrant working within a single department. researchers have also reported a lack of clarity on the registration requirements and variability on their interpretation. these challenges has low research progress and dissuade investigators from working with schedule one substances. that is why the administration's proposal to schedule it, includes a process with rapidly removing those with potential. this is critical because the class-wide scheduling with the structure alone bypasses the use of substance analysis of a compound of the potential.
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these will result in the permanent placements of thousands of compounds into schedule one, potentially including substances with little or no added potential and those that halt promise of fentanyl overdoses and pain and other conditions. it was participated in schedule one. the administration proposes an administration for schedule one research and conducted under an fda ind and more closely aligns with the process for schedule 2 substances. for methamphetamine and cocaine. it will remove the reviews and the process for modifying current registrations for the
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inventory control currently in place. the proposal also addresses aspects of the law that researchers report to be confusing burdensome and consistently applied. and facilitate transparency in the registration review from procedures. i am very grateful to hhs and doj for their support of this important proposal and to the committee for considering it i am happy to answer any questions you may have. >> thank you very much, doctor. i now am pleased to recognize dr. doc morton for your five minutes of testimony. thank you again. >> chairwoman eskew, i'm at the
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center of drug evaluate and research at the food and drug administration. thank you for being here today to discuss the comprehensive approach of fentanyl-related substances with the office of drug control policy, the department of justice and the department of health and human services as well as the important role that the fda plays in scheduling illicit substances that pose a danger to public health while also supporting the development of needed new drug therapies. as the committee has heard, new illicit synthetic drugs derived from fentanyl are being mixed with heroin and other drugs. the result has been a dramatic increase in opioid-related deaths in recent years. while the dea is believed to be the federal agency for regulating controlled substances and enforcing the controlled substances act. hhs has a number of critical responsibilities under the act, several of which have been delegated to the fda. given this, fda and dea have
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worked very closely together in the area of controlled substances including opioids including the work we are here to discuss today related to the appropriate level of control for the federal-related substances that are flooding the country with tragic results. >> dea issued a temporary order in 2014 as has been mentioned controlling the entire frs class. congress has since extended that order and through january 28, 2022. in 2020, dhs asked hhs to make a recommendation for the entire frs class, following careful evaluation, the recommendation was not possible for the frs class for several reasons. first, the class is vast with the number of covered substances. second, data on the pharmacological effects and then
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deem yol oj cal data about the harms and overdose deaths are more for 30 members of the frs class and third, among the individual frs members that we have pharmacological data, they have substances that do not activate the new opioid receptor. this activation is the primary pharmacology that would lead to opioid-related harms such as those caused by oxycodone and hydrocodone. the risk posed on fentanyl-related substances, while minimizing the impact of control on research and drug development by providing for a rapid de-control or re-control of individual members as appropriate when new data become available. this proposal would provide law enforcement with the tools they need to respond to the traffic
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and manufacturing of illicit frs substances, but because not all of them will demonstrate the high risk of abuse and risks of injury and in that way do not warrant control as a dangerous schedule one substance and because we believe some members of the frs class can have therapeutic potential. the proposal would rapidly remove an individual compound from scheduling, the most restrictive schedule in schedule one if sufficient data emerge that the substance does not share the pharmacological properties. under the streamlined approach for decontrol hshg hs should determine if the substance should be moved to a lower schedule or removed from scheduling altogether again, focused on the assessment of a pharmacology. this work would be on the new opioid receptor and the receptor responsible for the dangerous
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effects of opioids including sedation and respiratory suppression. we believe it would appropriately balance the public health risk posed of illicit substances while addressing the important need of suppressing scientific research to develop therapies and to improve our scientific understanding. we appreciate the combined work of the federal partners to develop this proposal and the willingness of this committee to discuss this today. the fda does all it can to support the important work on the critical public health issue. i am happy to answer any questions you have, thank you. >> thank you, doctor, and it's a pleasure to recognize mr. lewis millioni, now for your five minutes of testimony. welcome and thank you again. >> thank you, chairman eskew. thank you for inviting dea to
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testify today. the dea's mission is to protect the drug threats from harming the communities. i've had the privilege of serving as a dea for 20 years and i've worked in new york city investigating criminal drug networks pushing different drugs into our community and into our country. my dea brothers and sisters and administrator millgram and i have never seen anything as dangerous as the fentanyl threat. fentanyl is an existential threat to our country. fentanyl is killing countless americans every day in all our communities. it knows no geographic or economic bound and a synthetic drug, the supply and different variations of the drugs are limitless. who is manufacturing and pushing this deadly poison into the country. mexican cartels working with criminal chemical companies in
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china, they're exploiting the crisis by manufacturing massive quantities of fentanyl and flooding the countries with it and profiting from the devastation that they leave behind in our communities. dea's fentanyl seizures this year have reached an all-time high largely because of the temporary class wide scheduling of fentanyl-related substances. he cease 13,000 pounds of fentanyl this year and that's enough fentanyl to give every member of the united states a population of potentially lethal dose. what is extremely alarming is that mexican cartels and other criminal networks are mixing fentanyl with other drugs like cocaine, meth and heroin and also marketing the the fentanyl in a new form, fake, prescription pills. these pills are filled with deadly fentanyl and pushed on our population by these criminal networks. they're made and marketed to
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deceive users often on social media platforms using the target audience thinking that the fake pills are legitimate prescriptions, but they're not. so far this year, dea and our law enforcement partners have seized over 15 million fake pills. 10 million of these pills were laced with fentanyl. dea's lab testing confirmed that four out of 10 of these pills are laced with a potentially lethal dose. as i said earlier, dea's mission is to protect the public and we are laser focused on this threat. in september, we issued our first public safety alert in six years warning the public about fake pills laced with fentanyl. the prior public safety alert was also dealing with fentanyl. at the same time we launched a public awareness campaign titled one pill can kill, trying to get the message to anyone we can reach that just one of these fentanyl fake pills can kill a
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user. we also did a nationwide enforcement surge focused on the fentanyl and counterfeit threat over a period of six to eight weeks we took action in all of the dea offices around the country. we seize millions of fake pills and thousands of pounds of fentanyl powder and dozens of guns and arrested more than 800 drug traffickers. we would be relentless in the work that we have to do to protect the public. >> the fentanyl threat is an existential threat to our country. now more than ever it is critical that congress schedule fentanyl-related substances as a class to enable dea and the law enforcement partners to seize these substances before they enter the country and as they are encountered in our communities. dea is also committed to expanding and enhancing research on controlled substances and it is a key pillar of fighting overdose deaths and a critical part of dea's mission to protect
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the public. we look forward to continued collaboration with the agency partners to facilitate access to research and learn more about these substances. we at the dea are committed to doing anything that we can to protect the public from these dangerous drugs that are harming americans and devastating our communities. we look forward to working with congress and our interagency partners to address this threat and the nation's overdose epidemic. i look forward to taking your questions. thank you. >> thank you very much, mr. millioni. that is compelling testimony. we will now move to member questions, and i recognize myself for five minutes to do so. to dr. brock morton, since the temporary class wide scheduling of fentanyl-related substances began in 2018, overdose deaths
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and its contained in the testimony as well have only risen. tell us why the administration's proposal will succeed where the temporary scheduling hasn't. >> thank you, madam chairwoman. no single solution exists for a problem to confront us around the opioid crisis. so i believe we have to acknowledge that this is one important step among many that we need to take. one reason i believe this is a particularly important step is part of its focus on this class of substances. this class is causing particular harm. temporary scheduling has been effective and it has helped prevent control these substances and permanent scheduling will take the next step then and make it permanent to send a strong message. >> but even with the temporary scheduling, deaths have risen.
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the deaths have risen, i believe as a consequence of other factors that have occurred in the system. >> what are those? >> well, there are other social influences and one, simply, the economics of this misuse and abuse of opioids. we transitioned from a time where prescription opioids, prescription pills were driving a substantial fraction of the overdose deaths that were experienced to a place where the fentanyl and the fentanyl-related substances are causing a much larger fraction of the overdose deaths and this change in the complexion of the crisis leads for a need for us to focus this area. >> i wanted to ask mr. chester and millioni what role fentanyl-related substances play in the overdose epidemic relative to other opioids. >> sure.
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>> thank you for the questions. dea's main focus is protecting the public. >> targeting those that are causing the harm without question, mexican cartels are driving the substance into our country and they're driven by greed and they'll stop at nothing and their substances are so deadly with the analysis that are four out of 10 of the pills and only a small amount, a miniscule amount will potentially take the life of a user. so the very deadly substances and the cartels are driving them in here driven by greed and will stop at nothing. >> dr. volkov, the administration's proposal would make it easier to conduct research on all, and you mentioned this in your testimony and all schedule on substances and not just fentanyl-related substances. what's the importance of
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including this broader category of drugs instead of just focusing on frs. >> and turn your microphone up, please. >> to do research, is in this case, the opiate overdoses and the substance disorder problem that we face as a nation. for example, with the fentanyl overdoses, we're finding a difficulty in reverting some of those overdoses and people died despite the fact that they're giving it, we need to look at the psychological effects. researchers who work with them is crucial and indispensable. >> let me go back to mr. millioni.
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thank you, doctor. are -- are these -- the frs, do they come through the u.s. postal system? has dea worked with any of the social media let forms and relative to not carry carrying pharmaceutical ', spoeed pharmaceutical drugs and tell us more about the reach across other sectors other than what you, you know, the cartels that are highly responsible for moving into our country. >> our focus at the dea is wherever the harm is being caused and we have to work with our interagency partners and we'll work with anyone that we can to reduce the threat and reduce that harm. there is no question that the mexican cartels sourced with chemicals from china, they were manufacturing massive amounts and we work with our state,
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local and federal partners consistently around the country. >> are they carried in the u.s. mail, though? >> trafficking organizations will use every single possible method to get them into the united states and the distribution networks in the united states will use any means necessary to distribute this poison. >> i think you're saying yes. >> any conveyance is possible they'll use. >> thank you. the chair now is pleased to recognize mr. guthrie and ranking member for his five minutes of questions. >> i appreciate you all being here and to support doj and chose not to be there. and you have the opportunity to host round tables and the kentucky's attorney general, and daniel cameron was with us and local oible fishls and they had raptives and they had a discussion of the crisis and our
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commonwealth. dr. gupta, i met with him today and encouraged by his enthusiasm and i look forward to, hopefully i'll be successful to fight this plague. >> i do have to ask you the biden administration's proposal as schedule one drugs and does so without imposing mandatory minimums or trafficking these deadly substances and there's debate about mandatory minimums and not scheduling, and not applying the mandatory minimums with the scheduling of the analogs? >> it will have other data and relevant research and other members of this committee that will determine analogs that will lead to less than all of the related substances on our streets. >> thank you for the question, congressman. i would offer you a few things
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and i would offer mandatory minimums and it would have criminal justice reform and that having been said, in this proposal you're talking about a narrow class of substances that are causing harm in america's communities that are considered part of this proposal as part of an overall balance ask comprehensive approach that balances the safety of the american people, civil rights and also for researcher access. in terms of criminal justice elements and mandatory minimums, i know the department of justice has submitted a written statement, but i would defer to the department of justice on that. >> when it deals with the narrow class, we're all talking about killing people with the overdoses and it may be a narrow class and it is a substantial plague upon our society and two milligrams compared to 200
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milligrams with methamphetamine and is there a reason with fentanyl-related substances, but it keeps to the proposal and keeps the mandatory minimums or allows them to stand with drugs like cocaine and it's caution the overdoses with the others and why not address them all? >> right. and so when we're talking about this particular class of substances, i think it's important to note we have a few things. number one, we have fentanyl itself and the base fentanyl molecule and we have fentanyl analogs and in the category of fentanyl-related substances, and they've already been classified and scheduled, but as we talked about earlier, the universe of potential substances are 4,000 that are chemically possible here. we have an entire population of substances that have not yet been created, but have the potential to be created and that's what we're talking about
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in terms of fentanyl-related substances in this particular class as a whole, but as i said, when it comes to the criminal justice and it comes to the mandatory minimums i would have to defer to the department of justice. >> fentanyl analogs and the reason they're being created is because they're scheduled, in my opinion and excluding these from the mandatory minimums, it seems arbitrary. those federal analogs that have been identified and placed in schedule one or with a prommer creating one, regime. >> i mean, i and mr. millian, in your testimony you say we must use every term available and
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failed to mention how criminal penalty can be used in the mandatory minimums, if not, why not? and what are the alternatives? >> thank you for the question. dea as a law enforcement agency is focused on protecting the public from the greatest harm and greatest drug threat. there is no question that fentanyl is the greatest threat. it is killing americans every day, in every corner of the united states. our focus, our laser focus is getting these fentanyl substances permanently scheduled so we can stop them before they come into the country and weigh can seize them and take them when we encounter them in our communities. we also need them permanently scheduled so we can dismantle the drugs in our country. >> does that have an impact? >> dea is a law enforcement agency and we conduct our investigations and work with our
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prosecutorial partners and urge the judges to be enacted and that is for the judges to determine. >> i wish i had more time. my time has expired and i yield back. >> i wish we had more time. there are so many questions that need to be asked. the chair now recognizes the chairman of our committee, mr. pollone for his five minutes of questions. >> thank you, chairwoman eskew. >> i just wanted to know the frs proposal and there are fentanyl-relate the substances and the proposal put forward to congress and basically, what would each of you say to those of you who would express the concerns and their support and what happens if the current emergency scheduling order for nent nil-related substances expire, and maybe they can spend a minute or so answering the question and maybe i'll start
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with mr. millioni. >> thank you. at dea we are focused on those causing a harm to the country and helping those that are harmed. fentanyl, without a question is the most significant drug threat that we're facings and much better to be proactive in going with this. these drugs are deadly, and we need to get them permanently scheduled so we can stop them from coming across the border into the united states and we can deal with the mexican cartels that are pushing this into our country and when having this, we need to push them out of the country. >> my question is does that administration proposal accomplish that goal? >> we believe the administration's proposal will help us protect the public safety and health. >> okay. let me go to dr. brock morton, same question, because there are some that say we shouldn't be
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doing. or don't like the proposal. that's what i'm asking. >> the fda supports this proposal in its current form and we believe it achieves that important balance here already and placing the products under control and recognizing their deadly potential and providing science-based mechanism to support additional research which as dr. volkov believes it's necessary that we've all been making and with regards to confronting the fentanyl crisis. >> anything with the administration's proposal with the control of the class with a possibility of rapid de-control based on further science and research. it does achieve that goal. yes. >> i'll ask dr. volkov the same question, keeping in mind that we are getting the
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administration's proposal and the classified schedule. >> thanks for the question. indeed, we have been getting a lot of concerns from sciences, and that's why we are very supportive of these new proposals that will actually allow us not only to address the challenges of doing research on fentanyl, and related substances and other schedule one substances. in its current form, it provides a mechanism when it is found that some of these compounds may not have addiction potential and felt useful to remove them and let me just give you an example of why this is so important that we do that, and that is the most effective intervention that we have to save lives and that was schedule one. that schedule is similar of other opiate drugs like morphine. believe able to remove it gives
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us a powerful therapeutic and the provision as proposed would allow us to do that and it achieved protection and it will help us accelerate research. >> the one thing no one has asked is what happens if the current emergency scheduling expires and the same question and maybe you can address it. >> thank you, congressman. to answer that question, i would say that currently particularly in the era of synthetic drug use, this is the most dynamic drug trafficking and use environment that we have in our history say that these drugs are particularly deadly and because they're opioids, first use leads to chronic use very, very quickly as well as them being deadly in their own right and being able to create them faster than they can be scheduled
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individually and if we do not follow through on this proposal in some form. it would be profoundly dangerous for the american people to allow those drugs to be controlled in essentially for sale and for purchase and this proposition along with the more comprehensive approach that the administration is taking that includes prevention, reducing barriers to treatment and harm reduction as well as reducing the supply of illicit drugs in the united states we believe is the absolute right approach for the environment that we face. >> thank you. thank you, madam chair. the gentleman yields back. the chair is pleased to recognize miss mcmorris rogers, the ranking member for her five minutes of questions. >> thank you, madam chair. dr. volkow, we have received many letters of parents who lost their children to fentanyl. one ordered through snapchat.
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for school one morning found her son had passed away. if a pill is on the street you should assume it's not one made by the manufacturer in an fda-inspected facility. are there ways to test pills for the presence of fentanyl and is there research going on to prevent and stop overdoses? it is time that we did our part to permanently make these fentanyl-related substances illegal and i think we're all desperate for innovation to help arm parents to better protect and educate their children. >> thank you very much for this question. this is another example why we need to do research and indeed, we are doing research that relates to try to understand the tests that allow you to measure the drug that has been purchased contains fentanyl or not affects
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behavior of the users and also do they have the sensitivity to detect not just fentanyl or fentanyl-related substances. you are also doing research to improve the sensitivity so that it is not only additional tests, but can actually give us an indication of the amount of drugs or whether other drugs are mixed because what we are seeing also is that more and more people are dying from drug combinations. so in this they understand how to optimally implement testing and what guidelines we can give people so that they can take the most advantage from it. >> okay. thank you. >> mr. chester, mr. millioni, i just wanted to ask, do you agree and you've spoken to this a little bit, but for the record, do you agree that we cannot let fentanyl-related substances become unscheduled. yes, ma'am. weigh agree with that and that's why this proposal is the right
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approach. >> we agree with that, yes. >> thank you. do you agree that fentanyl-related substances should be permanently placed in schedule one. >> they should be permanently placed in schedule one until the research community can have access to them to determine if there is medical merit and whether they can fall permanently in the regime. >> why is it helpful for these compounds to be placed in schedule one? >> to make them illegal for purchase and sale in the united states until the research community has the ability to determine just exactly whether they're active in the body and how dangerous they are. and stop them from coming in the country and stop them from killing so many americans and seizing them in our community. >> would you speak to what you -- how you believe this would deter the bringing in and selling of fentanyl-related substances? >> yes, congresswoman. i'll answer it in the opposite
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and what if they're not illegal. that individual and incentivized to create the novel substances and sell them on the internet and sell them on social media and bring them to the united states in order to do this. as i spoke to in my oral statement you must deter the creation of these new substances before they can be created and introduced into our communities. many of these substances and you can argue the vast majority of them are active in the body and potentially dangerous to americans. >> is there anything you want to add? our job to the dea is to make the community safer and to stop the drugs in the united states and to investigate the groups that are trafficking in them. having this schedule gives us that ability and helps us make our country safer. it seems to me that related substances from mandatory minimums will encourage more trafficking and those substances
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and i'm worrying that we're playing politics with this issue by insistering on paring scheduling with fentanyl-related substances with importers of fentanyl-related substances were jeopardizing making these substances permanently illegal. we need to act and we need to act now permanently scheduled the fentanyl-related substances accountable for those substances, and it is a matter of life and death. i yield back. >> thank you very much. i don't quite understand the following and that is the need to study fentanyl-related issues. we already need to know what fentanyl does, and it's not clear to me everyone has stated
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how fentanyl-related substances and you state that, but you say the study has to continue in order to drop them from schedule one. what is it that you don't know about this drug and its related parts. madam chairwoman, i will start and then i will turn it over to the two doctors they share the table with. these substances have come common the relationship to the base fentanyl molecule and the fentanyl skeleton that we know its activity in the body. this involves substances that have modifications to that basis fentanyl skeleton. in some cases, these analogs have been tested and they've been subjected to testing and we understand with their activity in the body. they're talking about populations of substances that have not yet been created and
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not yet been identified and the testing has not been able to take place. however, they all share the same fentanyl skeleton and the basic molecular ident and from the policy perspective and that's how i set the four corners of the substances we're dealing with and i would defer to dr. volkov and dr. brock morton, as well. >> i think you describe it very well and it has to do with the notion that the chemical structure by itself would predict what the pharmacological impact could be and the molecule could make the molecule, very, very potent and it can make it inactive and it can activate the unique characteristics to derive that way. >> there could be a case that fentanyl is okay? is that what you're saying? >> there could be a case that a
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drug with a chemical structure similar to fentanyl, and cannot be as toxic or a ductive as the fentanyl molecule itself. yes? >> madam chairwoman, let me give you a concrete example. the dea shares the data to correct members of the frs class with the technical staffs talk to each other all of the time and we looked at a group of over 25 frss and we studied the pharmacology. among that group, there are members of that class and one in particular that has no activity to turn on the opioid receptor that we worry about here. in pack, it looks like an antagonist. it turns out it would be a blocker of the new opioid receptor in the way naloxone is a blocker of the new opioid receptor. locker of the mu
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opioid receptor. dr. volkow mentioned reversing the overdose effects of fentanyl. this is a substance that would have a potential for being a treatment for fentanyl. i'm not saying i know that it is. but i'm saying that's what we'll learn as we study these individual compounds, we'll understand if there are some that have no dangerous effects. some could be antagonists, could be new treatments for opioid disorder, new treatments for reversing overdoses. those are the things we need to make certain we don't lose even as we put this entire class under the control it merits given the larger public health need. >> madam chair, if i might, mr. chestner his opening statement said there were 4,800 potential
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analogues, based on math, and dr. throckmorton told us they've only looked at 25. that's w for yielding the time. i think i understand it a little bit better. it is complicated. the chair is now pleased to recognize the gentleman from north carolina, mr. butterfield, for his five minutes of questions. he's joining us -- >> good to see you. >> thank you very. much >> it's good to see you, madam chair. thanks so much for recognizing me this morning. certainly, thank you for your leadership on the committee. and to the ranking member, i love the spirit of cooperation that i see between you and the chair. thank you and your college for all the work that you're doing. we have great challenges in front of us. thank you for your cooperation. madam chair, as we consider legislation to address the opioid crisis. we must pay special attention to communities that have been
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historically marginalized and, i refer of course, to communities of color. recent findings from the nih found that within a subset of counties, disproportionately affected by the overdose epidemic, opioid overdose death rates, from 2018 to 2019, level off across all of our racial groups. with the exception of african americans. isn't that strange? among african american individuals, the opioid overdose death rate increased by some 40%. this is tragic. we must take action to address this trend. as history has shown us, communities of color are also disproportionately punished by drug policies. a report published by the -- commission this past january, found that in 2019, african american individuals composed a greater proportion of fentanyl
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and fentanyl analog offenders. of which, over 50% faced a mandatory minimum penalty. even though less than 8% were importers or had level so priors. these staggering statistics are just absolutely a sobering reminder of the stakes hailed in our discussion today. that is why it's important we have a bipartisan approach to this problem. mr. chester, let me ask you, thank you not only to mr. tester but all of our witnesses today. with the biden administration has been clear and its intent to address the disproportionate impact that past drug policies have had on communities of color. he said it in the campaign, he sing it today. from both a justice and public health perspective, how does the fentanyl related substances proposal meet that goal? >> thank you, congressman.
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and for that very reason, that is created in the contours of this proposal. while permanently scheduling this class of substances is what is done on the front end, in the interest of public safety, we must also understand that we can't do unintended harm by doing that. the very reason that you explained, is the reason why this proposal looks the way it does, why it's comprehensive and why we were able to bring together the department of justice and the department of health and human services to make sure that we do all of those considerations. >> let me now talk about criminal penalties. as a former judge, i'm particularly interested in this. there are concerns among criminal justice and civil rights organizations that this proposal will lead to harsh criminal penalties, even with the inclusion of provisions excluding fentanyl related
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substances from quantity of based mandatory minimums. do you agree with that assessment? if not, can you tell me? why >> congressman, as i mentioned before, the president opposes mandatory minimums and the biden harris administration is committed to criminal justice reform by eliminating raced an income based disparities in our criminal justice system. that is one of the foundational elements that the administration has used to approach this incredibly complex issue. when it comes to detailed criminal justice matters, i know the department of justice is submitting a statement for the record. i would defer to the department of justice on those matters, sir. >> thank you, my final question, mr. tester. what guardrails are in place, what guardrails should be considered to promote racial equity in drug enforcement efforts? >> congressman, i can only
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speak to the proposal that is here before us today. guardrails is probably the exact right term. if we were simply scheduling all these substances as a class, that was the bluntest instrument that we have. rather than do that, we ensure that we also, not only considered research provisions, but the criminal justice aspects to it as well. and so, we were able to provide the tools that are law enforcement community needs in order to be able to protect the community, but at the same time, make sure that we're not doing unintended harm. guardrails is the exact right term for the approach that we used. >> thank you very much, mister chester. conclude madam chair, by repeating wet you and others have said throughout this evening. it's absolutely unacceptable that the department of justice is participating in this conversation. shame on them. i hope we can hear condemn -- from them very soon.
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i yield. back >> here here, mr. butterfield. thank you. the chair is now recognized the gentleman from michigan. former chairman of the folk committee, we mr. upton, for your five minutes of questions. >> thank you, madam chair. i joined with everyone here, voicing our disdain for the department of justice not appearing, knowing that they have a number of months to be prepared for this. it is really sad on an important issue like this. i had the privilege of being selected by kevin mccarthy to serve in the white house commission on competent synthetic opioid trafficking. we've had great meetings. another one is scheduled for this afternoon, in fact. just a couple of weeks ago, i was able to send one of my staffers on a commission trip to mexico in the southern border. i am troubled about the administrations september recommendations on funnel related substances. a time when we're seeing the highest rates, ever 100,000 folks in 2020.
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it's disturbing that the administration seems to be weakening penalties for drug traffickers that are flooding every communities with deadly fentanyl and analogues. i don't hesitate to say, everyone here on this panel probably know somebody who was maybe part of that 100,000 in our families. mr. chester, is there a concern that the mexican drug cartels or large-scale manufacturers of these fentanyl analogues are going to take advantage of the loophole by producing fentanyl in a logs that are arbitrarily lower mandatory minimums for trafficking while continuing to take advantage of our lack of proper enforcement at the southern border? >> thank you for the question, congressman. i would say the first thing is that the men and women at customs and border protection and our law enforcement partners who are at the southwest border do a tremendous job.
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>> they do, absolutely. >> they absolutely. do >> they are overwhelmed, which is unfortunate. >> i would also tell you that, one of the reasons we need this proposal is to do just what you just described. to deter the creation of these new substances by making them illegal. we make them illegal before they've even been tested. we do that to ensure that drug traffickers understand that these are schedule one substances. you cannot create an awful substance based upon the fentanyl skeleton and sell it in the united states with impunity, that's not going to happen. i think it's critically important that, not only mexican drug traffickers but anyone else with the potential to make the substances and push them into the united states understands that this entire universe, 4800 substances, is illegal. >> i know that every one of us wants to make sure that we do everything that we can to deter the creation of these new analogues. there is no question about
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that. mr. million, we talked a little bit about numbers. 4800 potential analogues. i guess, the da has looked at a couple dozen. do any of them have a legitimate medical use? >> thank you for that question, i would defer that question to dr. dr.throckmorton or dr. folk all. >> okay, let me follow up with that. for those that may have legitimate medical use, are they in schedule to? are any of them are in schedule three or four? >> so, fentanyl has an approved medical use. it's a component and approved drugs that are on the market and available. it also has a high potential for abuse. it is in schedule to. there are no fentanyl related substances otherwise in
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schedule three, other than schedule one. >> mr. milione, and oh and d.c. press release from september of 21 announced that the administration's recommendations to congress in reducing illicit fentanyl related substances states that, and i quote, the justice department reported only eight cases where the f r s charges from the time temporary class scheduling was adopted in 2018, through december of 20. of which, only a handful included charges of quantity driven mandible minimums. given the extremely low prevalence of cases involving mandatory minimums, and stop toots to waive mandatory minimums like the safety -- for low level drug offenders, the substantial of -- why did the administration release recommendations that would further hamper enforcement of those crimes?
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>> congressman, my colleagues of the dea and myself, my whole career as a dea agent, we are laser focused up protecting these public from the substances. it's a top priority to have all these deadly substances scheduled in a class way so we can seize them at the border, investigate them in our country, and sees them when weak encounter them in our communities. >> my time is expired, thank you madam chair. >> thank you, gentlemen yields back. pleasure to recognize the gentlewoman from california. miss met sue e for her five minutes of questions. >> thank you madam chair. i want to thank you for having this hearing and for the witnesses for joining us today. i, along with others, or concerned about the rise of street drugs in -- including quantum upend pills that, contain fentanyl. we have to combat these.
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that includes cutting off how these products are getting into our communities and to help those addicted to get treatment. when congress passed the -- act in 2008, -- we recognize those great value in telemedicine. we worked to ensure that the laws strike a balance between safety and access. the dea restricted prescribing this drug to people in person. -- it's limited the amount of patients that contests has care. most recently, the da has waived that in requirement during the covid public health emergency to alive more prescribing of an atv and, telemedicine, regard this of the patients location. mr. milione, to start off the questions, i need a yes or no.
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how is the dea tracked any increased use in mat since waving the in-person requirement since covid-19 started. >> medical it -- >> it's a yes or no question. >> we are committed to -- >> yes or no. >> okay, has the waiver expanded access to substance use services and interventions during the pandemic? >> i'm sorry, can you repeat the question? >> has the waiver expanded access to substance use services and interventions during the pandemic? >> congresswoman, we are committed to working with our inter agency partners and have done so to expand access to treatment. we believe that is critical. helping those that are harmed. >> so, you're saying it has expanded access, is that correct? >> i'm saying we're committed to working with our inter agency partners to expand
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access to treatment and working with the white house. >> if i can interject there. we have been monitoring it from the resource perspective. the answer is yes, it has facilitated access to treatment. for example, it has made it accessible for people who are in the justice system on, parole, to have access to morphine much more widely. >> okay, let me ask this. the support act of 2018, required the dea to complete a special registration -- to allow more prescribed access telemedicine. i offered legislation that was authorized by committee house senators and committee organizations. to use this process to register as eligible providers sites. to my knowledge, dea has yet to carry out that congressional directive. mr. milione, when can congress to expect the dea to complete a statutory requirement, and
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issue the special rules in accordance with the law? >> congresswoman, as i said, we are committed to working with the inter agency community to expand access to treatment. i am not familiar with the specific answered that question. i'm happy to take that back and get back to. you >> yes, would you please do that. this addiction crisis has gone on far too long. it's always been clear to me that congress and dea must come together to meaningfully put an end to the opioid epidemic. now, i want to quickly shift focus to how the proposal before us today will impact research accessibility. >> doctor, there's been question about schedule one research registration will be limited to federal researches. can you clarify who will be eligible to conduct schedule one research under the provisions included in the administration proposal? would it include private researchers, or just federally funded researchers?
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doctor vocal? >> excuse, me use your microphone. >> yes, it will include private researchers and private investors as long as they have an ind with the fda. if they do not, then it will not include them. okay, so, researchers are already able to conduct research on schedule one. this change will allow them to use new process for other schedule one substances, such as marijuana? >> the proposal will, basically apply for all schedule one substances. it will expedite research on d agency, as well as any other substances that our schedule one. >> okay, thank you.
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i'm particularly interested in eroding existing barriers for federal law that researchers at academic medical centers, from studying schedule one substances. i'm schedules that our research agencies are working to find effective solutions and doing important work. thank you very much. i yield. back >> gentlewoman, yields back. chairs, please recognize the gentleman from virginia. mr. griffith, five minutes. >> thank you, madam chair. i appreciate the questions of all my colleagues in this panel is great, thank you all very much for being here. doctor volkow, let me start with you. much research on fentanyl analogues is necessary. , based on what we know now, have these final related substances compared to traditional fentanyl in terms of how they affect the body as well as their addictive properties? >> thanks for the question. there has not been as much
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research in fentanyl analogues. it has to do with a complexity and difficulty of doing research on schedule one substances. it takes longer, it's costly, it's cumbersome. that's deterred researchers. i'm optimistic that this proposal will make it easier so we can get more talent and expand our knowledge. >> i will tell, you and i appreciate that, i will tell you both that my colleagues and others have been starting to work for years to get more research on scuttle one. i have a bill that's already been introduced. bill two 4:05, it does that. i'm glad to be in agreement with the administration on this issue. we are actually looking this morning up at a bill that addresses the administrations questions and concerns that i hope to be introducing soon. i'm big on that.
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doctor, dr.throckmorton, if i could go to. you dr.volkow, don't put your mask on yet. i'm coming. back >> you indicated that there is one analog that might have some potential? could you provide me the name of that one? in your written testimony, there was an s. that indicated there might be more that did not problems. were there others that didn't function the way most opioids do? >> sure, thank you for the question. first, it's really important to understand that we have only looked at a relatively small number. without being able to give you the exact number, we are sharing the information as the dea. we're looking at them as much on the dea. we have a group defiant scientists focus on that. within that, group there's more than one compound that does appear to have other effects than activating the new opioid
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receptor. whether it is this one compound that i mentioned that appears to have this antagonism effect, or other compounds that have affects that other receptors -- there's another opioid receptor for instance, some compounds -- the major point, the point i want to make is that those exist. the details are important to study, but fundamentally they illustrate why just putting these all into schedule one is not sufficient. we have to do it along with the mechanism for removing these promising substances that have these other effects that are potentially less dangerous, so that we don't miss an opportunity to identify a new reversal agent like naloxone, or a new treatment for opioid use disorder. the small number of compounds illustrate that. >> i appreciate that, i want to get back to dr.volkow. so, based on your previous testimony and his testimony,
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when i'm gathering is that the administration wants to -- and tell me if i'm on the right path, put it all into schedule one permanently but then, have research available on the schedule one we -- so we can determine if it's helpful, and we can take it out later? -- or, if it has the decisional value, we can move forward with research, is that correct? >> you're asking question in terms of the scheduling. i think that's much better to send to the department of justice. >> they're not here, by the. way >> my view on this is that, as dr. toughened bird was saying, we have an opportunity to actually do research and come in with better overdose reversal --
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but better treatments for pain. as you mentioned, there is another opioid receptor. it can produce and algeria. it is not just in one area of the brain. to the extent that we could have a compound that specifically binds to it, you could have a -- that's not addictive. this is why science become so relevant. that's why we fought with them to try to make that knowledge is accessible. >> fortunately, my time is up. i've got lots of questions. this is a fabulous discussion, thank you all very much. thank you madam chair for holding it. >> the gentleman yields back, i think we all have many questions and to our witnesses, we will -- every member is going to be submitting a written question, detailed written questions to you. we look forward to your timely response to them. the chair now has the pleasure of recognizing the gentlewoman from florida. miss castor, five minutes.
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>> thank you, madam chair. thanks again for a terrific witnesses today. i really appreciate president biden and the administrations forceful and comprehensive strategy to tackle the opioid crisis, especially this deadly fentanyl and the synthetic opioids flooding into the country. unfortunately, my computing in the tampa bay area, we have not been immune. if you look back at the trends of the last five years, like other parts of the country, we have seen a dramatic increase in opioid deaths, fueled by synthetic opioids. i really want to compliment the tampa police department. they have an opioid task force where they brought in the dea, fbi, atf, and our nonprofit partners. our research university at the university of south florida, they are criminally pursuing and prosecuting the folks who are perpetuating the abuse going after the dealers.
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what they have advised me, is they cannot arrest their way out of this week. they are receiving doj grants a few years ago, after surveying everyone, they wanted to put more into crisis intervention. you all know that president biden and the democrats in congress, earlier in the year, past the american rescue plan. we devoted historic amounts of new money into crisis intervention, mental health, substance use disorder services. i'd like to know, mr. chester, are those monies now getting out? we really need them on the street. if my police department and nonprofit communities say they need more crisis intervention services to save lives, get folks treatment in addition to what they're doing on going after folks criminally. what is the status of the
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american rescue plan dollars getting out to communities like mine? >> yes, congresswoman. thank you very much. we will provide you an exact accurate answer as to what the status of all of those dollars are. i -- it would be irresponsible for me to say off the top of my head. we will let you know, for sure. what you described in the tampa area and the hillsborough county, is an approach that we -- and is the approach that the administration uses as well. why you need to have a strong law enforcement component, we also need to prevent drug use before it starts and reduce barriers to treatment and incorporate harm reduction. as a whole, and comprehensive approach. one dimension of this is inefficient to be able to do that. i appreciate you mentioning the american rescue plan, it was four billion dollars to expand
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substance use disorder services. it also include another 30 million dollars to support harvard auction interventions as well. i will also get you the exact answer on where those dollars are, i'd be glad to do that. >> didn't d.c. p and secretary best sarah firm from hhs, having to come together to do a deeper dive on how you support those collaboration's? can you tell us about that? >> yes, congresswoman. so, oh and the cpp and hhs we are incredibly close working together on the public health aspects of this. and i think it's important, also, to remember that the presidents fy 22 budget, in and of itself which includes ha jets and the federal drug control programs, it's 41 billion dollars. 41 billion dollars across the span of supply and demand
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reduction, applied to this difficult -- 670 million dollars above the active levels. a lot of that money goes to hhs. a lot of it goes to several other places throughout the federal government in order to do the many of the things that we're talking about today. to not only reduce supply of these drugs in our communities, but also the span of public health interventions that are necessary in order to reduce the poll of these drugs across our borders. thank you very much, i yield back. >> gentleman yields back. recognize the gentleman from florida, mr. bilirakis for his five minutes of questions. >> thank you madam chair, thank you for holding this hearing. i'm said that the overdose epidemic continues to worsen. instead of opioids over the past year. that includes my district, specifically paschal county.
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193 people have died from overdose since january. the vast majority involving fentanyl. this crisis has led me to call for a roundtable. i will be consulting with local leaders, providers and local law enforcement from past joe burrow county. we must continue to be engaged in all levels of government, fighting back against this surge on our communities. again, assistant director in a previous hearing, i questioned then acting director labelle about our relationship with china and the role it plays in preventing the injury and sell fentanyl. she mentioned that china is now channeling much of their fentanyl related substances and its components through mexico load both across the border.
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in fact, justice department unfortunately decided to not come here. and again, that is inexcusable, i agree with you madam chair. again, the attorney general stated and i quote, mexican criminal drugs are mass producing fentanyl and fentanyl laced pales using chemical sourced from china. they are distributing these pills through u.s. criminal networks. i don't think anybody will dispute that. these are designed to -- prescriptions such as oxycontin vicodin, adderall, xanax. the criminal drug network is still selling these pills social media, e-commerce, the dark web and distribution
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networks. these are widely available and this is a quote from the assistant ernie general. if we have learned anything from the covid pandemic. women who do you got the call of china. the trump administration was tough on china and border issues, as you know mr. chester, can you provide an update on how the administration is engaging, not only with mexico but with china directly and rating this deadly substance? and can you tell me whether china has been assistant enforcing its laws in this area. look at mechanisms that we have to hold china accountable to its commitment to banned the
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export of fentanyl and it's analogues. please mr. chester. >> yes congressman, thank you for the question. you have in your question identified the two fundamental countries involved in the flow of this country into united states. that is china and mexico. china's role has changed over time. there was a time pre-2019 when china was the source of finished fentanyl in fentanyl and logs coming into the united states. it is you the routed through mexico or quite significantly we talked about the postal service before on the web and shipped their consignment or postal service. we approach the chinese government in this was a conversation between the presidents on december of 2019. we asked the chinese government and heaps of class. they did that effect of may 2019.
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it had a couple of impacts. the first one was that we saw it direct from trying to united states shipment offensive analog. it goes down to essentially zero. that didn't solve the problem. and mexican drug trafficking organizations with the raw materials provided from china and chinese traffickers and the chemical business. so, it shifted the locus from china, to mexico and that enabled by china. >> i'd like to ask another question if i may, is that all right? >> another concern i have with sales event knowledge drugs online, you are getting to that. one prominent study is among the world's first digital native drug and has opened a
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new era of drug distribution of facilitating consumer transactions, rapid reactions and the delivery of retail rather than wholesale drug volumes through legal commercial delivery services. again mr. chester and deputy minister, if you allow them to respond madam chair. given the dynamics of legal immunity's ville bowl for the big tech companies to essentially incentivize them to bury their heads in the sand, house administration working with these companies, if at all to prevent these illegal sales. what is a level of transparency and information shared between these companies and law enforcement? first attorney or director minister place. >> yes congressman, i will tell you that you have identified a key part of the problem.
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it includes social media and i'd like to say within the limits. and provide specific action that they should be taken. will you identifies a critical component of this threat. >> this is allowable please? >> oh, okay. >> finish answering a question briefly. >> mr. billion please? >> we focus on the largest part to protect the public. i've said that through the hearing. >> you have. >> right? >> you have. >> it's critical permission. >> you've been consistent. >> you mentioned mexico in china, certainly mexican cartels are fought in the country working with chinese companies. >> but you are not directing --
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you're not answering the direct question. that is who are you working with? it has been testified that there are social media platforms in such. i think that's with the gentleman's asking. i ask the same question, who is dea working with? can you name any of the companies? is their outrage? if there is, with whom have you've been successful? if, not have they turned you down? congress needs to do something. >> where we are focused is where the threat is. the social media platform, e-commerce platforms being used. we focus our investigative efforts there. >> well or have. >> we will continue every day to do that. >> so you are doing it? >> we are focused on whatever the threat is. if social media platforms are being used or e-commerce platforms are being used or mexican cartels are being used. >> they are being used is, that correct? >> there's no doubt that social media companies should do more
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to prevent their platforms from pushing's poison into our homes. >> thank you for following up madam chair, i appreciate it. >> madam chair canada say the fda and we would be happy to talk to you about this. we agree it is and drug sales. especially online drug sales very seriously. since 2018, some of the internet providers and groups that control access to the internet. the service providers, we're happy to talk with you more. thank you doctor. >> the gentleman from florida yields back and pleasure to recognize the gentleman from maryland. >> good morning when i'm, chair thank you very much for this hearing.
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this is delicate and a complicated topic. there are a lot of obstacles to navigate in issues to address. maryland hasn't escaped the surge of of this pandemic that we are seeing where epidemic really other related deaths. and we are interested in how you are going to address this and strike the right balance here. that is the effort you have been undertaking -- the proposal attempts to do that. i would like to get a little bit back into the weeds on this. given the significance of the scheduling recommendation for
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permanent fentanyl related substances. i would like to hear more about that process. so, can you lay out for us plainly. you've done us a little bit, i'd like you to come back to it. the scientific or medical evidence it is needed to remove or reschedule and substance. >> thank you congressman. there are two parts and possible answers to that question. i just want to clarify, are you asking about the f r s class proposal that the administration is putting forward? or are you talking about the more general approach that has been historically used to remove the substance and change the scheduling? >> i'm speaking out more generally, what is the kind of scientific reference points that we use when we are removing our scheduling, rescheduling a substance for that matter? >> so, the general process
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involves each factor that is laid out in statue. we are obliged -- the fda's obliged to look at each one of those factors. they may include things from the pharmacology these accepted medical uses, look at all these eight factors. within provided recommendation to hhs. in this case, we would have to conclude that the available data suggests that the compound has no potential based on those fall eight factors. that is a considerable amount of data that is needed to be developed. >> so, you have anticipated a little bit next question. you are alluding that you want to do reschedule fentanyl related. hhs would only consider one of these a factors that you are
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mentioning. i'm curious, can you describe and determine which factors would be required? can you just draw that comparison if you could? >> yeah, thank you congressman it's a great question. the focus on the one factor which is the one factor related to the pharmacology comes from the focus of the f r s class legislation as a whole. so, the idea -- it reflects this pharmacology and the drug causes an effect on this receptor. these effects are pharmacological like what we see with fentanyl, hard to put on, ox another lethal things. we believe is that if we are satisfied that in fact that pharmacology is not present with one particular compound.
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we it's based on all the available data, not just that factor. that compound belongs in other places in the schedule. it may still have obese potential, we don't yet have all the information. we it is not a substance that has a high risk of abuse and misuse like oxymoron, fentanyl. so it belongs in a lower part of the schedule, schedule three we orgy controlled entirely. it's not that we are ignoring any day, that we will look at all the available data. we said we are focusing on the same part of the compounds effect that led to it being placed into schedule one in the first place. >> thank you, it's pretty complicated. stuff i appreciate those answers, i think really helpful to us and understanding the various proposals that are coming forward. we're trying to do something responsible from the legislative standpoint. with that madam chair, i yield my time back. >> the gentleman yields back. onsible fromthe chair is pleaseo
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recognize the gentleman from indiana, dr. bush on. you have five unanswered questions. >> i want to thank you the chair and the ranking member for holding this hearing on drug overdose and fentanyl related substances. i do want to mention that without demand there's no supply. i think for many years we have not addressed with the factors on our country they created demand for the substances. we should do that. member of the committee's help in combat substance abuse. i don't particularly get the connection that proposal a larger discussion i disagree
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with the administration with this it sent our country backwards in many ways in this battle against drugs. one of the contributors is that we halted elective surgery as a procedure that a lot of patience. many people were left in pain, bad knees, bad heads and other things. and let understand the reason for a short while, many states waited too long to reinstitute these types of treatments. new york state for example has done this because of the omicron variant. it's before we even have a case in the u.s.. i think it's problematic. one saudis are gonna get relief, that's more likely for them to return to opioids to manage the pain. it can obviously to abuse. it has been described, a lot of
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the prescription drugs that have been described is decreasing the use. their list is getting higher. these patients can used to better control their pain. >> thank you doctor. short answer the second question, absolutely s. we are doing anything we can to prioritize the development of safe alternatives to opioids. that the weather devices or drugs. we recognize that there are two forms to those alternatives to the drugs. they can be drugs that look like opioids but that do not have the addiction and overdose financial that many of our current opioids do. that is an area of strong importance for us. >> can i just say this, that's what's important defcon procedures in place.
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if we want to schedule these in class to make sure that we find one of those, we can get that back to schedule to. to patients have access? >> but not agree more with you. we talk regular really we have to acknowledge that we cannot have this -- we have other medicines that treat pain medicine let's less severe. opioids are uniquely effective in certain places. so, we need to do everything we can to understand the science better. just so we can identify non opioid alternatives that work for those severe pains, and of life pain and things like that. again, those are the highest priorities for us as a senator. we stand ready to extend priority review. we have other mechanisms and will do anything we can to help. >> we are congress have also
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had a payment structure for a period of time with these non opioid alternatives the reality is that these are cheap, if you have a more expensive non opioid product we under diagnostic we -- it may not be used if it's gonna cost them more money. we have worked on that part of it to make sure there's reimbursement to use non opioid alternatives. we >> mr. chester, we have talked about the illicit drugs in mexico how are they getting into the country? >> they are in mexico, they are being created, how are they getting here? >> we short, because i have a follow-up. >> principally across the southwest border. we >> so, if we were to work to secure the border better with that help?
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>> we there are multiple vectors by with which they came in. the southwest border, but also through the mail system and also through others. if we did changes in the mail system to allow the fda will email we -- each one of them has jokes in it, we allow them to not have to open every one of those. with >> the most effective thing we can do is our relationship with mexico without the tour the production of the drugs themselves. >> not to criticize any other government, but do you realize that the cartels name out of money involved is very difficult to we get public officials we to engage this process both and the -- i yield back. >> the gentleman yields back, the chair's place to recognize the gentleman from vermont, mr. walsh for his five minutes of
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questions. >> thank you very much madam chair. it is for so many americans and mcmorris rogers describes those who and it's a desperate aspire. there's really two things, but we're not talking about the dealers. we are talking about to get americans who funded unsolved in the grip we. we need treatment more than we need prosecution of those folks. we all that's not the topic of this hearing, we need to rebuild this. people who are alone and lonely we who are dealing with covid and don't have support systems, they often make a mistake thinking and opioid might be a support system that they want we. the second thing though that is
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very disturbing is where we do have an overreliance in the criminal justice system, rather than a treatment we got back about americans being much more highly prosecuted. we won a person of color being prosecuted are significantly higher, maybe 14 times as high. we so, it's another reason in my view why there's overreliance a prosecution versus treatment with for the users not the dealers. we that is something that we have to be mindful of. we let me ask you, thank you for your work by the way. we how do we ensure that we are taking the right steps in the criminal justice system? trying to address the public health crisis, we are also ensuring that we are not exacerbating an already
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problematic criminal justice system that does have disproportionate impact on people of color. >> thank you congressman. at the dea, we are very concerned about those that are looking to harm in our communities. obviously, with something as deadly as fentanyl that is our primary concern. we are focused on the very significant drug threats. and we're working with our inter agency partners to do that. we are focused on the biggest drug threats. right now this fentanyl and a close second is meth and feta mean. with putting our country and we are disturbing -- it's going all across the country. >> on that topic, a lot of us here we have seen the benefit of telemedicine. we that is a tool that can be helpful to provide treatment for the individuals, the ones that are going after the mexican cartel. that is really true for those of us who represent rural
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districts. there are many temporary flexibilities in place right now to law telemedicine. we want to ask about the telehealth ability to prescribe. earlier this year, they indicated a rule might be coming. it is regarding telemedicine we. and what might be the status of this rule to ensure the patients are getting the care that they need. >> as i said, we are focused on doing whatever we can to help those that are harmed. i know that we are working within our agency partners on vacancy some of the controlled substance act. we >> your role in that is very important because pivotal responsibility we look for harden effective. reinforcement. we already focus your resources
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and facilitate treatment for people? we so, i thank you for that. i think all the witnesses as well. i yield back. >> ouija recognizing the gentleman from florida, mr. durham for your five minutes of questions we. >> thank you madam chair for hosting this. i'm here today to discuss the most important issue of proper scheduling fentanyl and logs. i fully support we -- i am proud to cosponsor the fight fentanyl act introduced by my colleagues. i also support strong punishments for those who are responsible for producing and distributing fentanyl in odds on our streets. the cartels are producing synthetic opioids. they are pouring over our
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southern border. they are assisted by chinese chemical companies but the precursors. they found trafficking and will only incentivize the spread of the substances in our communities i think the biden administration proposal gets one thing absolutely right. that is the department scheduling of the fentanyl in a logs. i think it failed and was shortsighted to exclude fentanyl and logs from mandatory minimum sentencing. you know, the fentanyl analogues are literally as been said before poison on our streets. and a single drug bust in my district earlier this year seized two ounces -- i'm sorry, two pounds of fentanyl. two pounds of pure fentanyl is potentially enough to kill 80 million people.
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we are talking about wiping up cities. minutes prescribed as a medication, i'm a doctor's well, and health care setting we administer this and microgram doses. that is 1 millionth of a gram. excluding one of these deadly drugs world from the mandatory sentencing is just simply irresponsible. i will shift the illicit drug market towards moving more of these analog through our communities. i think that now is no time. these are not the charges touring courage this leniency. the proposal we review today will empower unorganized fentanyl producers. they are getting a precursors from chemical companies in china. so, mister milley, on a quick question in the da's 2020 intelligence report there to
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turn the channels a number one source of producing these precursors. is that still true? >> yes. >> let's, good bets fact we can put out. doctor, is the dea abel -- this is interesting to me is it science end of this thing. and they confidently identify the sources essential in a logs when he sees drugs? >> i think i would defer to the dea on their detection and deciding where the songs came from. mr. million? >> can you confidently determine the origin of a compound and analog when you sees it? is there enough chemical analysis that you know the telltale signatures of where it came from? >> we have a profiling program
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that looks at all of that. >> i'm pleased, thank you so much. mr. really on again. as the administration dedicated enough resources to our southern border to adequately empower introduce that fentanyl trafficking an analog of trafficking across our southern border? >> we are very concerned with the threat of fentanyl. we're very concerned with what's going on in mexico. every, day agents on the southwest border and throughout the country are investigating these criminal drug networks. >> are there particular tools that you would like us to provide? >> congressman, we can always use more resources. this is a very difficult, and challenging problem we're gonna use more resources. >> thank you very much. i will vote for this bill i'm glad we're doing. it i'm disappointed that there is no mention made of the problem we have of sourcing all these drugs across our southern border. with that madam chair i yield back. >> dr. dunn i yield back.
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the chair is pleased to recognize the gentleman from california first five minutes of questions. >> thank you very much madam chairwoman i appreciate this opportunity to discuss this critical an important issue. when it comes to overdosing, they are rising and it's clear we must do it we can to act to control the distribution, sale and use of fentanyl related substances. to do this successfully, congress must address this as a public health crisis that it. as rather than a problem of not enough enforcement. i am and concerned that that is why scheduling takes head of guilty until proven innocent. that would criminalize compounds which haven't even been discovered yet. this approach applies harsh, federal penalties and restrictions even if a compound turns out to be non harmful. it could be helpful, as a
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matter of fact for example fentanyl and fentanyl related substances are in a category of compounds which also includes medication for pain, diarrhea, parkinson's disease, depression, anxiety and dementia. i'd like to submit for the record this paperson's disease and dementia. i would like to enter the cautionary tale for fentanyl compound. it was presented by a doctor on this topic. she warns that it is likely to have unintended consequences, including severely limiting biomedical research and in the long term adversely impacting public health, end quote. dr. volkow, you think we all agree that the current classification system has made
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it very difficult for scientists to reassess the scheduling of compounds which may have medicinal properties. for example, we know that compounds in marijuana have legitimate and beneficial medical uses despite it being schedule 1. so i'm encouraged to see that efforts are being made to allow researchers to study the effects of various compounds in this proposal. however, i am concerned with the idea of treating entire categories of compounds as a schedule 1 for enforcement purposes but different for research purposes. i think this puts the entire system into question. schedule 1 compounds are, by definition, compounds with no medical use and a high potential for abuse. i'll say that again. schedule 1 compounds are, by definition, compounds with no medical use and a high potential for abuse. in this specific situation, if we don't have the data to support fentanyl-related
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substances as schedule 1, why is it being related to an entire category and also including compounds which haven't even been discovered yet? >> in general, certainly i would be also very much worried about just taking chemical structure as a way of scheduling. but i also recognize that we're really in an emergency situation, and it's not business as usual, and we have never seen so many people dying from overdoses ever, and fentanyl is one of the drivers as well as fentanyl-related compounds. they are highly, highly profitable. they are not going to go away. and we need to actually do everything that we can to make it harder for the manufacturer and dealers to do it. at the same time, we need to also be very conscious that the way we're going to be addressing the crisis, as has been said by the other agencies, is not one intervention. we need to actually provide
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prevention, treatment, recovery, and that requires research. that's why i'm very supportive of these provisions because it will give us an opportunity to make and research simpler and faster on the schedule 1 compounds. we're in an emergency situation. >> yes, it definitely is an emergency situation. i also would like to add to what my colleagues have mentioned about our disappointment that the department of justice is not here. i hope we would have been able to hear from the justice department about supporting this proposal, but i appreciate the feedback of the witnesses that are here today. being that the doj is not here, i want to ask a question of the dea and also nbcp. the bottom line, why is it being recommended we continue the same strategy of criminalizing
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compounds which clearly isn't working so far? >> i'll take that. thank you for the question. fentanyl is killing hundreds of people every day in this country. tens of thousands of people are dying every year. mexican cartels are flooding the country with these substances, working with chemical companies in china and they're profiting off the opioid crisis in our country. our focus is on those who are harming the country and bringing them to justice, but also it's critical for us to have these drugs scheduled so that we can prevent them from coming in and harming our public citizens in our country and also seizing it when we encounter it, as well as dismantling the groups that are profiting off this. >> thank you. my time is expired. i yield back. >> the gentleman yields back. the chair now recognizes the
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gentleman from georgia, mr. carter, for your five minutes. >> thank you, madam chair. i'm so glad we're having this hearing. i thank you for calling this hearing, madam chair, but i'm frustrated. i'm very frustrated. here we are at this hearing and we have a border where fentanyl is pouring across the border, pouring across the border. enough fentanyl was seized that killed 2.1 billion people. enough fentanyl has been seize d at that border, but yet do we have anyone at the border? no. it's ridiculous we're doing this. drug traffickers are murderers, period. drug traffickers are murderers. ask any of the 100,000 family
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members of the 100,000 people who died this past year as a result of drug overdoses. ask them, they'll tell you, they are murderers. until we resolve the situation in our southern border, anything we do is ridiculous. this has got to be addressed. again, if we have to subpoena the department of justice, subpoena the homeland security to get them here to answer these questions. i want to ask you, mr. chester, if there ever was a time to debate mandatory minimum laws, do you believe it should be now with the unmatched lethality of fentanyl-related substances, which are even more lethal than fentanyl itself? >> thank you for your question, congressman, and i want to talk
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to you from a policy perspective. i'm not an attorney and i'm not part of the department of justice, but i do want to answer your question directly. the first element of that is this. what is not included in that exception are fentanyl analogs that have already been identified and are already placed in the scheduling regime of which there have been close to 30 that have been seized and identified by cbp and other partners that we deal with. that's fentanyl, acetyl fentanyl. this provision does not apply. it also does not apply for those substances in which there is death or serious bodily injury. that also does not apply. so what you have is kind of this very narrow substances that have not been identified where this applies. i want to make sure we're clear
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on that provision. to the method of how we gather these up, it is true these substances have not been tested in vitro, that is true. but it is also true, as you state, that this classical set of substances is markedly dangerous for those we have detected and potentially dangerous for those we have yet to detect and have been able to put to testing and that's what's important. >> being a pharmacist, i carried the update of the pharmacy rules in georgia, and every year we would identify the dangerous drugs and include them on there, and every year they would change them just technically, and we would be behind. we were behind before we even started. mr. milione, i'm going to ask you the same question. do you need me to repeat it? >> no, thank you. we're focused every day, obviously, on the threat that we're facing with these drugs. this is an existential threat to
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the country, the fentanyl substances that are coming in. what is critical for us is the classwide scheduling so we can seize them before they come in and seize them when we encounter them. as a law enforcement agency, we will continue to investigate those groups that are harming our communities, and we will do everything we can to get help for those that are being harmed. prosecutors make decisions about charging, judges follow the law, they will sentence. we will continue to investigate and protect the public with all the tools that we have. >> let me ask you something. isn't it true -- i'll ask you, mr. milione -- i'm sorry. >> that's all right. >> isn't it true that the fentanyl and fentanyl variants are so potent that even in low doses, they can be dangerous? so much so that dea agents are warned about touching them. >> fentanyl is an incredibly lethal substance.
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two grams are potentially dangerous. >> that you can get over the internet, that's the ones you're talking about? >> that's correct. >> madam chair, i cannot believe that the department of justice and the department of homeland security are not here. we should subpoena them and make them come here. thank you, madam chair, and i yield back. >> the gentleman yields back. i think when an agency declines to come and testify, they injure their own case. this is the people's house, and we're examining with every legitimacy the administration's proposal. and it's an agency that's key in this, so i think that they hurt themselves by the choices they've made, and i think it's regrettable and it's troubling to me. i think we all feel the same way about it. okay. the chair now recognizes the
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gentleman from california, dr. ruiz, for your five minutes of questions. >> thank you very much, and thank you for this hearing. i'm saddened that we are here yet again to discuss this crisis that continues to sweep our nation, affecting each and every one of our communities. as a physician i treated far too many patients with substance use disorder in the emergency department, many fighting for their lives. just this week i heard from one of my constituents, jennifer from bermuda dunes in my district of california, who tragically lost her son last year. steven loza was just 18 years old and had graduated from high school when he died from fentanyl poisoning. he should have had his whole life ahead of him. unfortunately, this case is not unique. these tragedies cannot continue. we must continue fighting for
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jennifer, steven, and families across the country who have been afflicted by this crisis and enact policies that help prevent more suffering and unnecessary loss of life. earlier this year, the biden-harris administration's office of national drug control policy released their drug policy priorities, which included various bold approaches to reduce overdose deaths. i applied this proactive approach. this overdose epidemic is one of the most important public health issues of our time and requires urgency. mr. chester, i am interested in hearing about the administration's progress on these priorities, and more specifically, what major actions has the administration taken to increase access to evidence-based treatment services since releasing its policies priorities? >> thank you, congressman. i'd like to bring you up to date on a few things. at the administration level, the american rescue plan invested
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more than $4 billion, and that was tool lou hhs and samsa resources to expand funding als million specifically for harm reduction. we know how important that is in saving lives and preventing overdoses. the president's fy '22 budget, $41 billion across the national drug control program, but that's both demand reduction and supply reduction, as well, and that's about $670 million above the fy '22 enacted. we have also designated six new counties as part of the highly successful program. we have also funded the nationwide expansion of the overdose response strategy, which is not only law enforcement, but also brings together critical public health interventions in our communities as well. we met with more than 300 state, local, and tribal leaders from
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all 50 states and territories to talk about how they could use opioid litigation settlement dollars and focus them in the right place for substance use disorders. >> since you mentioned tribes, we know many, like in many other areas of health care, there's marked disparities in access to substance abuse treatment for underserved communities of color, rural communities, and tribes. so what steps has the biden/harris administration taken or is planning to take to close these disparities to access to treatment? >> yes, congressman. i would offer you two things. the first one is there is never a time that we talk about a particular policy that we don't mention state, local, and tribal as well. we understand the unique aspects and the unique needs of the tribal community and the fact that substance use disorder has fallen on our tribal communities in an outsized fashion. two things i can offer. one was, and this is hhs,
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released practice guidelines for the administration of buprenorphine for treating oud. we know there has been expansion of use of buprenorphine over the covid pandemic and that's been incredibly useful in getting more people into treatment, and the other thing we're proud of the fact the dea in working with ondcp lifted a decade-long moratorium on opioid treatment programs that have a mobile component that's critically important for rural and tribal communities to be able to extend treatment in areas that are traditionally underserved. so that's two examples of things that we're very proud of that we have done, just within the last 10 or 11 months. >> thank you, and are these efforts also conducted and these outreach educational efforts also conducted in spanish? >> i can get you the absolute answer on that, but what i can
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tell you is i just -- let me just talk about the drug-free communities program for a second. because the drug-free communities program is entirely local. their motto and they're managed through the office of national drug control policy. their motto is local problems require local solutions, and that is one that i would be glad to provide you some more information on that and it being culturally and linguistically focused because we're very proud of that program and announced $13.2 million in funds just over this past year. >> thank you. i yield back. >> gentleman's time has expired. chair is pleased to recognize the gentleman from pennsylvania, doctor joyce, for five minutes. >> thank you for convening this hearing on what we all recognize as a grave and important matter. we are aware that the expiration date for the current emergency
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class-wide scheduling order for fentanyl related substances is coming up next january. or now will be likely punted until february. congress cannot, i repeat, congress cannot allow this life-saving order to expire, and rather finally needs to pass legislation to permanently schedule fentanyl related substances to empower our brave law enforcement officers to get these deadly drugs off the streets. and to bring the traffickers and the dealers of these poisons to justice. in face of this escalating crisis, i share with the chair and the ranking member's concerns that the dog hasn't even allowed themselves to be present at this important hearing. drug overdoses are killing more americans than ever before, and nearly two-thirds of these deaths are the fault of synthetic opioids like fentanyl
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and fentanyl related substances. my district in pennsylvania has been hit hard by this crisis over the last two years. every single one of the ten counties that i represent has experienced increase, increases in the overdose death rates from 2019 to 2020. over 30% in each and every one of those ten counties. while i am pleased to see the biden administration finally release a plan to permanently schedule these substances, i worry that this plan is misguided and that the changes of the proposed mandatory minimum sentences for these drugs specifically will have the reversed impact and encourage the traffickers, the traffickers that you talked about to us today, to continue to bring these substances into our communities and kill our families and our friends. my first question is for you, mr. millone. is it reasonable to believe that
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class-wide scheduling would not expand the application of mandatory minimum sentences as some might suggest? >> thank you, congressman. our job at the dea is to make sure that we're making our communities safer. and that includes conducting the investigations into those groups that are flooding our country with fentanyl. as i said before, fentanyl is an incredibly dangerous substance. what's critical is those drugs are classified permanently so that we can stop those drugs from coming into the country and seize them and dismantle the networks that we're investigating. >> my next question is for dr. throckmorton. as a physician, i followed with interest the discussion about streamlining the process to remove fentanyl related substances from schedule i based on just one factor, not all eight. does that mean a fentanyl related substance could be removed from schedule i even if there is no medical use?
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>> short answer is yes. under the current proposal. it would remain in schedule iii presumably if the pharmacology anticipated it would have low amount of potential for abuse, would still be controlled under other various aspects of drug development. my agency has a series of controls that we have over drugs that are under study, as new drugs for us. investigational review boards would continue watching them, for instance, but the short answer is, yes, under the current proposal, the focus is on the pharmacology that we anticipate what would cause greatest harm. identifying that pharmacology, and if it exists, that compound stays in schedule i. should not leave the tightest possible controls. >> i agree with that. mr. millone, i think you said
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sent some important issues to us. you stated these cartels are permeaing our southern border, flooding every community with fentanyl related substances, driven by greed, your terms, and stopping at nothing, your terms, and i agree. my question is for you, mr. chester. is it not incredibly dangerous to leave the door open for hypothetical future compounds? why not fix the threat today? wouldn't it be prudent to be on course if there are research exemptions to address those as the research guides us? >> yes. i appreciate your question, doctor. i agree with your characterization of the threat, but nat that we're leaving the door open. the fundamental element of this particular proposal is to gather these substances up and bring them under control. substances not even yet created. i think that's the important aspect of this, that we're permanently scheduling these substances as schedule i, until the research community has the
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ability to access them and determine their proper place in the scheduling regime. >> i thank you all for being here today. this is informative, and this is an important hearing to have. again, i want to state my grave concerns that the department of justice refused to participate in this hearing today. thank you, and i yield. >> thank you, doctor. always a gentleman. the chair is happy to recognize the gentlewoman from michigan, mrs. dingel, for her five minutes of questions. >> thank you, madam chair. i would also like to thank our witnesses for being here today. and just tell you how important this hearing is. most of you know i lost my sister to an opioid drug overdose, but in the last year, also lost a family member from fentanyl. and we all talk about the southern border, but people don't talk about the fact that the canadian border is also very
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dangerous source, and law enforcement at the time told me about how deadly this is that's coming in, and most of the people that are buying it have no idea what's about to happen to them, and it is why this is all so important. as we continue this discussion, and we have these witnesses, the justice department should be here because i do believe the people selling this are murderers. front and center, we need to take that on. it would be good to hear about additional policies the biden administration is proposing. we all recognize that multifaceted problems require multifaceted solutions with over 100,000 deaths in only a year period in this country and almost 3,000 just in michigan, it's important we consider all possible strategies to combat the crisis. mr. chester, could you briefly summarize other avenues the biden administration is pursuing to reduce overdose deaths, particularly those around
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prevention, treatment, harm reduction, and recovery services? >> yes, congresswoman, thank you very much. the first thing is, you mentioned it, prevention. that is preventing drug use before it starts. the second one is reducing barriers and access to treatment. leading to long-term recovery, and some of those we talked about earlier, particularly extending into underserved populations, reducing financial and other barriers to accessing treatment, but the third thing is harm reduction. and i think it's critically important that we remember that harm reduction is a critical part of insuring that individuals are not losing their lives to overdose. and that is not only service programs, fentanyl test strips which i know have been spoken about a lot in the press lately, but also accessed in the lock zone. the lock zone is critically important as a harm reduction intervention to make sure that we can insure that americans do not lose their lives to opioid
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overdose. thank you. >> let me build on that, mr. chester. a number of states have adopted co-prescribing programs, when a doctor pairs an opioid prescription with a prescription of the overdose reversal drug, like naloxone. what control can increased utilization of pro-prescribing programs play in assisting the response to the opioid crisis? >> thank you for the question. i know congressman sarbanes is also a supporter of co-prescribing. what i can tell you is, and specifically about ondcp's role is we look across the span of possible policies, possible interventions, and those that could be extended across the country, that could be useful and co-prescribing is one thing we have looked at and we'll continue to look at.
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>> if i may interject. i'm sorry, i apologize, but i also think the importance of science in helping us address the crisis should be highlighted because the reality is we're faced with a drug that we don't have so much information to optimally reverse overdoses or to optimally treatment, so therefore, the importance, again, of doing clinical research that will allow us to implement policies that are more likely to be effective. ? i think it's very important and i think it was you who spoke earlier is one of my biggest bugaboos is we don't have pain relievers that are not addictive. we need to be investing in more pain reduction medicines. it's a combination of reasons why people are using these drugs, and i do want to say my colleague, french hill, and i are leading legislation preventing overdoses and saving lives act to provide state grants to encourage uptakes of these programs, which have proven effective in helping address the opioid crisis.
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i was going to ask you all more questions, but i have 30 seconds left. so i won't. i'll yield back. madam chair, but i will have additional questions for the panel, especially on what they think we should be considering the policies to reduce overdose deaths. thank you, and i yield back my time. >> the gentlewoman yields back. i think all members are going to be heard from in terms of detailed question to our witnesses because there is so much more to be learned and questions answered. so we'll be doing deep dives on that. the chair is pleased to recognize the gentleman from texas, mr. crenshaw, for five minutes. >> thank you, madam chair. thank you all for being here. it's an important topic. and i think a lot of potential for bipartisan agreement and policy making. i want to start -- i want to try
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to understand the mandatory minimum policy by the administration and understand what the intent it and get at the repercussions. mr. tester, this is for you. the administration supports mandatory minimums in cases where death or serious bodily injury can be directly linked to the fentanyl analog that was trafficked. i understand where we're going with this. you don't want to put people in jail just because they're a drug addict, but you do want to put the drug dealers in jail. the problem is why support this standard rather than a standard that would get at the serious trafficking cases? these are notoriously hard to prove that this overdose was directly linked via intent and the substance to this dealer, having a very hard time prosecuting that. >> thank you for your question, congressman. i'll give you the policy aspect of it, but i would like defer to the department of justice, and i know they submitted a statement for the record on kind of the arcanna of it as well, but i
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will tell you, you asked the question i we were coming from, and i want to make sure we're clear. i would make a different distinction than the one you made between the trafficker and actually the user and make a distinction actually among, upon the substance itself. you mentioned fentanyl analogs. those fentanyl analogs that have been identified and tested, those are schedule i, they have been placed in the scheduling regime. that's not what we're talking about. what we're talking about is we have gathered up an entire class of substances, uncreated, that within that class of substance, there may be substances that either have medical merit or are not the least bit harmful. they're not any more harmful than water. the question is what do you do with those particular cases where an individual has been convicted of a substance that is only within schedule i by virtue of its class scheduling. that's why that particular guardrail was put in. >> okay, and maybe if doj was
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here, we would ask them what we could do to make it easier to prosecute drug dealers with bad intent that are dealing fentanyl that is killing people. i mean, just going to simplify what we're trying to get at, and this seems to get in the way of it. on a separate note, the administration talks about harm reduction as a method to deal with this crisis. san francisco, philadelphia, new york city, they're promoting harm reduction programs. they had great success in mitigating opioid abuse. more so than cities that have just cracked down harder on illegal drug use. and what does the literature say on safe injection sites? are these workable solutions or not? >> i can get you an exact answer on the kind of the science behind safe injection sites, and in fact, i could turn it over to the doctor. in broader terms when it comes to harm reduction, it's saving people's lives and preventing them from overdosing to drugs. that's kind of one element.
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the second element of that is it is the first step on the road, hopefully, to treatment leading to long-term recovery. that is ultimately the goal, but when it comes to the science behind safe injection sites, dr. volkow, if you would like to add something? >> we have done research in other countries but not in the united states. from that research, it has mitigated some of the adverse effects of drug use, including hiv, hepatitis c, and overdoses, but we need to test this in our country. >> i understand. thank you for being here. thank you for your answers. i do want to point out something, when it comes to the opioid crisis and 100,000 deaths in the past year, we can talk about mandatory minimums, we can talk about harm reduction, and these things are very important to talk about. but we wouldn't have to be talking about those things if there was no fentanyl in the system in the first place. now, we're lucky in a sense because we know where it's coming from.
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chinese, chinese supplies the chemicals, and the mexican drug cartels are pushing it across our southern border. i say we're lucky to know that because it allows us to focus on something. it allows us to focus on the source of the problem, which is an open southern border, where drug cartels are simultaneously shoving hundreds of people at a time across the border to tie up border patrol, meanwhile, border patrol is not actually patrolling the border, and the drug cartels can put their drugs through the gaps in our border. and then they come here, and we seize hundreds and hundreds of pounds of fentanyl, which can kill tens of millions of americans. we seize that on a regular basis. i would like to submit for the record from operation lone star these statistics from texas specifically. and i yield back. thank you. >> gentleman yields back. chair recognizes the gentlewoman from new hampshire, ms. custer, for your five minutes of
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questions. are you there? ms. custer? going, going, gone. the chair recognizes the gentlewoman from illinois -- >> i'm right here. >> are you there? >> i'm right here. i apologize. >> okay. you're recognized. >> i'm so sorry. i apologize. thank you so much. delighted to be here today to discuss the administration's recommendations on combatting the fentanyl overdose epidemic and i want to submit for the record a letter from over 150 advocacy groups and public health professionals in support of bipartisan legislation that i have introduced with congresswoman blunt rochester to address the fentanyl overdose crisis. it's called the stop fentanyl act. and i hope our colleagues on both sides of the aisle will join us. in new hampshire, we saw very early on the devastation of this addiction epidemic. what began in the doctor's
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office with overprescribing pain medication evolved into a full blown opioid epidemic that could literally be tracked along our highway map. communities hooked on pills, they were prescribed by doctors, were inundated with less costly alternative, first heroin, and now other drugs and substances. today, this epidemic continues to evolve with stronger, more dangerous syntheticopeioids like fentanyl and fentanyl related substances, and what makes this even more concerning is that oftentimes these lethal synthetic opioids are laced into other drugs, unbeknownst to the person struggling with addiction. since coming to congress, i have worked tirelessly with my colleagues on the bipartisan addiction and mental health task force and on this committee to help those with substance use disorder. but our work continues. as many have already pointed out just the past year, over 100,000
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americans have died of drug overdose, but that number does not begin to capture the many other overdoses that have occurred during the pandemic. i want to turn my attention to a comprehensive, holistic approach to ending this epidemic. one that invests in public health treatment, in prevention, and in support for those battling with substance use disorders. i want to focus on the interagency working group examining and developing its recommendations on scheduling fentanyl. as policymakers, one of the challenges in keeping up with the pace of the overdose epidemic is working with lagging data, from different sources, that's not integrated in a readily available way. and we have focused on this in the stop fentanyl act. mr. chester, the covid pandemic has shown the value in realtime data. we know the number of deaths the
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next day, yet we wait months for overdose data and critical information on this synthetic opioids. how can we better access data in both public safety and public health? >> thank you, congresswoman, for the question. we agree, data is the key to understanding the environment the best that we can, understanding where our vulnerabilities are in being able to come up with policies in order to close those vulnerabilities. we are better than we used to be in data, particularly the national center for health statistics, within cdc, now has the provisional data which we get on a quarterly basis and is much faster than the data that we got before previously, and that's been very important. the second thing that we do is we stay very much in touch with our state, local, and tribal partners who can feed us bottoms up data, although you can't extrapolate it across the
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country, it gives us a sense for our understanding of what the environment is, and the third one is to listen to the congress. and the congress over the years has been clear about what it's looking for in terms of this particular legislative proposal and that was helpful in allowing the departments of justice and hhs to be able to shape what you have -- what we have here. but we don't disagree with the fact that we have some gaps on data, and it's an area that we need to work pretty heavily. >> okay. thank you. i'm going to ask this last question with mr. chester and dr. throckmorton, a key priority of mine and the administration is increasing resources for harm reduction. can you tell us what more can we done at the fda perspective to make naloxone more accessible? >> i can start off and then i'll turn it over to
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dr. throckmorton. we know that naloxone is incredibly effective at preventing overdoses and saving lives. and that increasing naloxone availability across the country is one of the critical elements of harm reduction under the first year priorities under the biden/harris administration. but i'll turn it over to doug. >> thank you very much. i could not agree more. one of the fda's highest priorities is expanding the formulations, the available types of naloxone that people can make use of. just recently, we approved a higher dose formulation of naloxone to make available for people that might use it. we believe we have recently started, we have continued -- >> i have to give your response for the record. my time is well up and i'll yield up. >> happy to, ma'am. thank you. >> time has expired. the chair is more than pleased
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to yield to the gentlewoman from illinois, ms. kelly, for your five minutes. >> thank you, madam chair and ranking member guthrie, for holding this important hearing to curb the opioid crisis in this country. unfortunately, overdose deaths are beginning to rise even before the pandemic. i know we have talked a lot about that. and black and brown communities are experiencing the fastest increase rates of overdose deaths involving synthetic opioids. i continue to be concerned about using the criminal justice system to address a public health issue. i worry about the impact this will have on the very communities that are suffering in silence without the sympathy of the media and of society at large. we need to make sure that we are taking a deep look at how this proposal to move fentanyl related substances to schedule i may perpetuate existing racial disparities in our criminal justice system. mr. chester, what is the
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evidence that increasing criminal penalties of fentanyl related substances will actually reduce drug related mortality and morbidity, particularly among black and brown communities? >> thank you, ma'am. i would offer you this, that what we are not doing is increasing criminal penalties but rather gathering up a class of substances and placing them in schedule i. i think it's an important distinction. i appreciate your question, but we're not increasing penalties. we're taking substances that are dangerous substances as part of a class of dangerous substances and placing them in schedule i, not increasing penalties. >> okay. as fentanyl related substances are increasingly criminalized, this may increase the development of new synthetic opioids. how does ondcp plan to address this to avoid a whack-a-mole approach to regulating harmful synthetic opioids?
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>> thank you, congresswoman. you used the exact right word. you characterized it perfectly, whack-a-mole. we have to insure that that's not what we're doing. i think we need to understand a few things. the first one is, it is clear that when we take an action, drug traffickers change their behavior. it's almost impossible to get ahead of that, but at least we can close the gap. this particular action, class scheduling, was done for the exact reason that you just mentioned. so we were in a situation in the past, and by the way, we asked the chinese government to do this as well, and they did. we were in a situation in the past where we would detect a fentanyl analog in the united states. we knew it came from china. we would go to the chinese and say please hold someone accountable. they say it's not illegal in our country but we'll do that. and by the time it was made illegal in china, the traffickers had already moved to another substance. that necessitates class scheduling. in my oral statement when i said they're creating these
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substances faster than we can schedule them exactly the situation you're talking about. >> thanks. i want to make sure congress is taking a holistic approach to tackling this epidemic, which includes investing significantly in prevention, treatment, and recovery also. this committee has heard from the research community that current research requirements on the controlled substance act take significant time and effort to obtain. one of the criticisms of placing substances in schedule i is the chilling effect that may have on research of those substances. dr. volkow, the administration's fentanyl related substances proposal seeks to establish a simplified process that would align research, registration for all schedule i substances more closely with the research registration process for schedule ii substances. can you explain the difference between the two processes? >> yeah, on this we'll make it
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basically the proposal to do research on schedule i equivalent to doing research on schedule ii. and it eliminates the need of an extra review of the proposal of the researcher, which is not necessary for schedule ii but schedule i. and that takes time and is much more lengthy, so it will facilitate that, in addition to other provisions that will make it easier for researchers to actually perform their work. so it is an advance, and we're excited and supportive of this proposal. >> thank you so much. research is essential for understanding the opioid epidemic, identifying effective solutions, and informing our policy making, and it is critical that we insure that no barriers to this type of research exists. so thank you so much, and thank you to all of the witnesses. i yield back.
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>> i'm going to recognize the gentlewoman from california, ms. bear agone, but i also want to say before she begins her questioning that we have votes on the floor. we still have several members that are in the queue to ask their question of the witnesses. so i think the good news for the witnesses is you're going to get a break for at least 45 minutes. and the downside is that we're going to be back after that 45 minutes to finish out our hearing by allowing all members who wish to question the time to do so. so with that, i recognize the gentlewoman from california for your five minutes of questions and then we'll recess after her questions for 45 minutes. >> thank you, madam chair. i'm glad that we're here today
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to discuss legislation that will hopefully allow us to stem the overdose epidemic that has taken far too many lives too soon. i want thank all of our witnesses today for your testimony. in los angeles county and across the country, we are seeing an unprecedented humanitarian crisis of people experiencing homelessness that requires a compassionate, thoughtful public health response. according to the los angeles county department of public health, between 2017 and 2019, people experiencing homelessness in l.a. county were more than 36 times more likely to die of a drug overdose compared to the general l.a. county population. drug overdose deaths involving fentanyl tripled between 2018 and 2020. and drug overdose remains the primary cause of death for people experiencing homelessness in l.a. county. comprehensive drug policy aimed at reducing harm caused by fentanyl related substances must include an integrated public
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health approach and investments in infrastructure that addresses upstream social determinants of health. this question is for mr. chester. can you discuss strategies the office of national drug control policy are working on to tackle social factors like homelessness that exacerbate illicit fentanyl related substance overdoses among more than 500,000 people experiencing homelessness in our country? >> yes, thank you, congresswoman, for that question. i think you have brought up a very important point. the first thing i would like to say is that evidence based prevention and prevention strategies are a key part of the first year priorities that the office has laid out for the biden/harris administration when it comes to drug policy. the second thing i'll tell you is that the social determine
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of drug use are part of our academic understanding of what it is that leads to the nishation of drug use in the first place. that is one of the key areas that the office will be working on in the coming year in order to reduce overall drug use around the country. and as we say, and we have talked about it several times today, there is absolutely a direct linkage among the fentanyl related substances that are available in our communities, their trafficking, and their use in our communities and therefore overdose deaths. you can't pull one of those strands apart. you need to be able to deal with it in a comprehensive and holistic fashion, and that's the approach that we have taken. >> thank you. dr. volkow, in los angeles county, there was a 52% increase in accidental drug overdose deaths, and a 136.4% increase in the number of fentanyl related death rates during the first ten months of the pandemic compared to the same period in 2019.
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this alarming uptick of deaths is disproportionately affecting people of color. how can improving research with fentanyl related substances help us address the opioid overdose crisis and combat drug overdose deaths within highly populated urban areas, particularly among people of color? >> first of all, i think that we resonate completely with you about the social determinance of health, because they pertain very much about why you're seeing such a dramatic increase in overdose mortality in the covid pandemic and why it's affecting some populations more than others. understanding the processes and the challenges that people that are homeless, for example, is crucial for providing solutions. without it, people that don't have a place to sleep cannot sustain treatment, nor can they actually when they go to shelters, get exposed to others taking drugs. so understanding the social and
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cultural factors that have been exacerbated during the pandemic including the uncertainties and the social isolation is crucial for containing the epidemic that we are seeing. in terms of how the fentanyl research can help us basically be better able to do treatment and prevention is first of all, we need to understand what are the characteristics of the use of the substances, who is using them, how they are combining them. we need to also understand actually how to optimize them before reverse them, and third, how do we not just initiate people on treatment, but retain them on treatment so they can recover and we can prevent an overdose. that requires that we work with -- that researches get their hands on working with fentanyl. so that they can develop models and they can actually develop new products, new ways of testing it, new ways of being
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able to document where people are dying from what so you can test rapidly right away as opposed to waiting months. these are just some of the examples. >> thank you so much, doctor. i'm out of time. with that i yield back. >> gentlewoman yields back. we'll now recess for 45 minutes. why don't we say 50 minutes? the ranking member and myself will race back after the third -- after we cast our third vote, and the witnesses take a break. i think that there you'll find the cafeteria and whatever downstairs here in the raburn building. thank you. i'm sorry we couldn't conclude before votes, but we have -- you are an all-star cast, with just one department missing. but you can see that there is very deep, broad interest in this issue. and you're the experts. and we want to make sure that
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everyone is able to question. so we'll be back at 2:15.


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