Subcommittee Finished Day One of Two Day Legislative Hearing
WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held part one of a two-day hearing examining 25 bipartisan prevention and public health solutions to help combat the opioid crisis.
“The unprecedented plague of opioid addiction and substance use disorder in our country requires an unprecedented response,” stated #FullCmte Chairman Greg Walden (R-OR). “While this committee spearheaded the legislative efforts in CARA and Cures that has already devoted a record amount of federal resources to address this crisis, we can and must do more to meet this growing need.”
#SubHealth Chairman Burgess echoed Chairman Walden’s comments, saying, “This epidemic is in our hospitals, in our living rooms, and on our streets. Our partners at federal agencies must rise up to the challenge and deliver these vital resources for the states and communities most hurt by this crisis.”
#SubHealth heard from two panels of witnesses today – one composed of federal officials and a second panel tailored to bills under the Food and Drug Administration’s (FDA) jurisdiction and other research, development, and prevention initiatives.
Among the 25 bills, #SubHealth focused on the following bills today:
NOTE: Some bills have not received formal titles and instead are denoted by working descriptions.
H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act (AINS), authored by #SubDCCP Chairman Bob Latta (R-OH), will direct HHS to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts and strategies to combat the opioid crisis, and provide states and localities a centralized access point on available funding resources.
- Dr. Anne Schuchat, Acting Director, Centers for Disease Control and Prevention (CDC), highlighted the importance of good and accessible data in her witness statement, also telling Chairman Latta, “This has been a fast moving epidemic and we have seen changes in the principle factors that are driving it. So, the more timely our data are, the more rapidly we can target interventions.”
H.R. 5002, the Advancing Cutting Edge (ACE) Research Act, authored by Rep. Debbie Dingell (D-MI) and #SubEnergy Chairman Fred Upton (R-MI), will provide the National Institutes of Health (NIH) with new, flexible authorities to conduct innovative research and spur urgently needed research on new non-addictive pain medications.
- FDA Commissioner Scott Gottlieb, M.D., highlighted the agency’s current efforts to collect data about pain medication with abuse-deterrent features, and vowed this data would become available soon to help inform policy decisions.
H.R. __, FDA Accelerated Approval & Breakthrough Therapy Status, will take steps to make FDA pathways like the accelerated approval program available to take on the opioid crisis, leading to quicker access to novel, new treatments to treat pain and addiction.
- Ms. Cartier Esham, Executive Vice President, Emerging Companies, Biotechnology Innovation Organization (BIO), told the subcommittee that, “The current state of innovation for next generation pain and addiction therapies holds promise but requires a more conducive policy environment focused on enabling access and incentivizing the investment needed to unleash the full potential innovation to change the paradigm of treatment and improve the lives of patients. Today, less than four percent of total venture investment in the biopharmaceutical sector is being directed into companies whose lead product is a novel pain therapy.”
FDA Commissioner Gottlieb speaks during the first panel of witnesses.
H.R. __, FDA Packaging and Disposal, authored by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC), will direct FDA to work with manufacturers to establish programs for efficient return or destruction of unused Schedule II drugs, with an emphasis on opioids. These methods could include mail-back pouches to secure facilities for incineration, or methods to immediately inactivate/render unattractive unused drugs. In addition, this bill will facilitate utilization of packaging that may reduce overprescribing of opioids. Finally, this bill will require the Government Accountability Office (GAO) to study new and innovative technologies that claim to be able to safely dispose of opioids and other unused medications. GAO would review and detail the effectiveness of these disposal methods.
- Commissioner Gottlieb spoke to Rep. Hudson’s bill and outlined current FDA efforts to address this area, saying, “In December, FDA hosted a public workshop on the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioids. We discussed, among other topics, how new types of packaging, such as unit dose blister packs, could encourage prescribers to opt for shorter durations of use, thereby limiting the number of opioids dispensed to patients. …This could also address the problem of excess supply in the U.S., as there would be fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”
H.R. __, FDA and International Mail, authored by #SubCommTech Chairman Marsha Blackburn (R-TN), will streamline and enhance tools the Food and Drug Administration (FDA) has available to effectively intercept illegal products. In doing so, this bill will create efficiencies for government resources and better protect American citizens from dangerous imported substances.
- Commissioner Gottlieb spoke about the FDA’s current processes and limitations in screening for counterfeit or illicit drugs and how Chairman Blackburn’s bill would bolster their efforts saying, “…this could make us far more efficient in those facilities.” Commissioner Gottlieb also stated in his opening remarks, “Our aim is to stop, inspect, and test more packages that contain suspicious drugs.”
Dr. John Holaday gives his opening statement during the second panel.
H.R. __, FDA Opioid Sparing, authored by Reps. Barbara Comstock (R-VA) and Ben Ray Lujan (D-NM), will direct FDA to articulate clear data collection methods that could be used to inform opioid-sparing labeling claims for products that may replace, delay, or reduce or the use of opioid analgesics.
- Ms. Esham voiced her support of this measure, explaining, “This legislation would enable FDA and stakeholder collaborations to discuss issues relating to data collection on opioid sparing and inclusion of such information in product labeling to inform development of guidance. Specifically, the legislation would direct FDA to develop guidance that would better enable utilization of innovative clinical trial designs to ethically and efficiently collect data on opioid sparing, improve the development and acceptance of endpoints that measure the reduction of chronic pain and opioid use, improve the ability to utilize real world evidence and enable information about opioid sparing data to be included in the label of a product.”
H.R. __, FDA Long-term Efficacy, authored by Rep. Jerry McNerney (D-CA) and #SubOversight Vice Chairman Morgan Griffith (R-VA), will enhance FDA’s authorities and enforcement tools to ensure timely post-marketing studies for chronically administered opioids.
- Commissioner Gottlieb explained that FDA has “…the authority to request post-market studies that are mandated as part of approval on the basis of safety considerations, not purely on an efficacy consideration.” When asked if this bill would be helpful to the agency’s role, FDA Commissioner Gottlieb responded, “One of the questions that continues to come up around opioids is the issues associated with their long-term use. A lot of these, as you know, have not been studied for chronic administration and yet they are chronically administered. So there are certain important questions that we could answer by properly studying the chronic administration…”
H.R. __, FDA Misuse/Abuse, authored by #SubHealth Ranking Member Gene Green (D-TX), will clarify FDA’s authority to consider misuse and abuse as part of the drug approval and assessment process for opioids. It would also augment FDA’s capacity to take necessary action to minimize the public health consequences of opioid misuse and abuse.
- Commissioner Gottlieb provided an example about the removal of the opioid Opana ER, stating, “We believe we have the legal authority to look at risks associated purely with illicit use as a component of how we assess risk and benefit, both pre- and post-market. We exercised that authority in this case, but I do think this is an opportunity for Congress to think about how that authority can be tailored specifically against this challenge, and particularly in respect with controlled susbstances.”
H.R. 449, the Synthetic Drug Awareness Act, authored by Rep. Hakeem Jeffries (D-NY), will require the U.S. Surgeon General to submit a comprehensive report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 in order to further educate parents and the medical community on the health effects of synthetics.
Ms. Sue Thau, Public Policy Consultant, Community Anti-Drug Coalitions of America, testified in support of the bill saying, “Having a Surgeon General’s report on the actual public health effects of synthetic drug use on 12-to-18 year olds will be invaluable. …We need this report to put a spotlight on the facts and information about the actual effects of synthetic drugs on youth so that more attention and resources will be mobilized to aggressively address this critical public health issue more intentionally and comprehensively.”
#SubHealth Vice Chairman Brett Guthrie (R-KY) listens to a witness’ response to the subcommittee.
H.R. __, the Comprehensive Opioid Recovery Centers Act of 2018, authored by #SubHealth Vice Chairman Brett Guthrie (R-KY), will establish Comprehensive Opioid Recovery Centers (CORCs) that will serve as models for comprehensive treatment and recovery. CORCs would utilize the full range of FDA-approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery as productive members of society.
H.R. 5261, the Treatment, Education, And Community Help (TEACH) to Combat Addiction Act, authored by Rep. Bill Johnson (R-OH), will support Centers of Excellence, or institutions of learning that have championed SUD treatment and pain management education to improve how health professionals are taught about both SUD and pain.
- Dr. Christopher M. Jones, PharmD., M.P.H., Director of the National Mental Health and Substance Use Policy Laboratory, Substance Abuse and Mental Health Services Administration (SAMHSA), spoke broadly about centers of excellence and the benefits they have shown, saying, “Thinking about centers for excellence, or hub and spoke models, nurse care manager models, those are things that have been studied in different states that have shown increased retention, reduced drug use, improved outcomes.”
Discussion Draft, PDMPs, authored by #SubOversight Vice Chairman Morgan Griffith (R-VA), will improve current federal support for Prescription Drug Monitoring Programs (PDMPs) to enhance surveillance, data collection, and integration into physician clinical workflow so that timely, complete and accurate information will get into the hands of providers and dispensers, allowing them to make the best clinical decisions for their patients.
- In an exchange with #SubEnvironment Chairman John Shimkus (R-IL), Acting Director Schuchat stressed the importance of inter-state interoperability and how some states are already doing this work. “We basically need to speed it up and make it very easy. …The resources that we’ve been getting have helped, but additional resources that are proposed will help tremendously.”
Dr. Jones listens to a member’s question.
H.R. 5272, the Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act, authored by Reps. Steve Stivers (R-OH) and Eliot Engel (D-NY), will require entities applying for funding that would be used for programs or activities that address mental health or SUD, to submit materials to HHS demonstrating that the programs or activities are evidence-based.
- Dr. Jones said SAMHSA is conducting a needs-assessment, program by program, to see what is needed and how these objectives and initiatives can be implemented.
H.R. 3545, the Overdose Prevention and Patient Safety Act (AINS), authored by Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR), will permit SUD records to be shared in accordance with Health Insurance Portability and Accountability Act (HIPAA), and for the purposes of treatment. The bill would also increase the penalties in the event of disclosure, add breach notification requirements, and provide discrimination prohibitions to protect people seeking and receiving SUD treatment.
- Dr. Jones spoke to the administration’s ongoing efforts to modernize the regulation of SUD treatment records (often called “Part 2”), explaining, “While the administration has not taken a position on any particular bill related to Part 2, I want to assure you that SAMHSA supports further consideration of the benefits of aligning the statute governing Part 2 with HIPAA.”
Stay tuned for a full recap of bills reviewed by #SubHealth following the conclusion of Thursday’s part two of this hearing.
For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click here.