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#SubHealth Reviews Legislation to Improve Patient Safety and Bolster Enforcement Tools in Midst of Opioid Crisis


WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing reviewing eight legislative proposals pertaining to the Controlled Substances Act, as part of the committee’s ongoing efforts to combat the opioid crisis.

“The statistics are heartbreaking: on average 115 Americans die every day from an opioid overdose – that is nearly five people per hour,” said #SubHealth Chairman Burgess. “I said it before and will say it again. Now more than ever, we must come together and strengthen our commitment to fight this scourge – it requires an all-hands-on-deck approach.”

Chairman Walden delivers his opening statement.

“Today marks our first of three legislative hearings this Congress,” said #FullCmte Chairman Greg Walden (R-OR). “…In the coming weeks, this subcommittee will continue its hard work with legislative hearings related to public health and prevention efforts, as well as issues pertaining to insurance coverage. This is just the beginning and represents only a fraction of the ideas members from across the country have formulated to overcome this epidemic.”

#SubHealth considered the following eight bills:

H.R. 2851, the Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act, authored by Rep. John Katko (R-NY), will give law enforcement the tools they need to help get illicit synthetic drugs, like fentanyl, off our streets without compromising important public health and research protections. H.R. 2851 will also modernize scheduling guidelines to keep pace with the fast-changing nature of synthetic drugs.

Ms. Gibson listens to member questions.

When #FullCmte Chairman Walden asked Ms. Susan Gibson, Deputy Assistant Attorney, Diversion Control Division, Drug Enforcement Administration (DEA) if H.R. 2851 would be effective in ridding these dangerous illicit drugs and their analogues from our communities, she acknowledged that it would in fact play a role and help streamline the DEA’s processes. “These people are peddling death,” said Ms. Gibson.

H.R. 5041, the Safe Disposal of Unused Medication Act, authored by Reps. Tim Walberg (R-MI) and Debbie Dingell (D-MI), will help reduce the number of unused controlled substances at risk of diversion or misuse by allowing hospice workers to safely dispose of these medications in patients’ homes.

Speaking in support of H.R. 5041, Dr. John Mulder, Director, Trillium Institute, stated, “Under current law, unless a state or locality has enacted legislation that otherwise allows hospices to dispose of unused medications, hospice staff may not handle or destroy such medications in the home. As a result, it is frequently the case that hospice home visiting staff – who may be the last professional to visit the home in connection with a patient’s death – must leave dangerous medications with a high risk for diversion and misuse by those for whom the drug was never intended in the home environment. These circumstances create a significant challenge for hospice personnel.”

H.R. __, the Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, a discussion draft written by Reps. Ryan Costello (R-PA) and Rick Nolan (D-MN) will make long overdue updates in federal law to improve dispensing of implantable and injectable therapies – developed to make abuse, misuse, and diversion more difficult.

Dr. Ponni Subbiah, Chief Medical officer, Indivior PLC, testified in support of the discussion draft authored by Reps. Costello and Nolan, saying, “We agree with the committee that there is a role for Congress, and the administration, to update laws to allow for new medical technologies. We support the proposed legislation to remove any ambiguity in the current law to ensure that patients with opioid use disorder and their providers have the same level of access to these innovative treatments as they do to other injectable products. We believe this technical clarification will ensure the safest distribution channels for these new treatments.”

Rep. Carter prepares for the hearing.

H.R. __, the Special Registration for Telemedicine Clarification Act of 2018, a discussion draft written by Reps. Buddy Carter (R-GA) and Cheri Bustos (D-IL) will clarify telemedicine waivers. Federal law permits the Attorney General to issue a special registration to health care providers to prescribe controlled substances via telemedicine in legitimate emergency situations, such as a lack of access to an in-person specialist. Unfortunately, the waiver process has never been implemented through regulation, and some patients do not have the emergency access they need to treatment. This bipartisan draft directs the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 30 days of passage of the law.

H.R. __, the Improving Access to Remote Behavioral Health Treatment Act of 2018, a discussion draft written by Reps. Gregg Harper (R-MS) and Doris Matsui (D-CA) will expand access for patients in rural and underserved communities who may live near community mental health or addiction treatment centers, but not a hospital or state-licensed clinic. Without a DEA registration these health facilities do not qualify for the Ryan Haight Act’s telemedicine exception, and are unable to provide care to patients in need. This proposal would direct the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 120 days of passage of the law for these treatment facilities to register with the DEA to engage in the practice of telemedicine.

Mr. Richard Nance, Director, Utah County Department of Drug and Alcohol Prevention and Treatment, highlighted the discussion drafts authored by Reps. Carter and Bustos, and by Reps. Harper and Matsui, respectively, noting, the policies detailed “would support the ability of legitimate clinics to register with DEA for purposes of complying with the Ryan Haight Act.” Mr. Nance also noted these policies strike the right balance, giving DEA greater transparency and jurisdiction, while also balancing the burden placed on health care providers.

Witnesses listen to member questions.

H.R. __, the Tableting and Encapsulating Machine Regulation Act of 2018, authored by Rep. David Kustoff (R-TN), will make it tougher to traffick synthetic drugs. This bill will give the DEA the authority to regulate the use of tableting and encapsulating machines with requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions.

While supportive of efforts by the DEA to investigate individuals using tableting and encapsulating machines, Mr. Thomas Cosgrove, Partner, Covington and Burling LLP, cautioned the discussion draft authored by Rep. Kustoff, suggesting revisions. Mr. Cosgrove, who previously worked at the U.S. Food and Drug Administration (FDA), stated, “If Congress decides that enhanced regulation of tableting and encapsulating machines is needed, I would encourage a more tailored approach that builds on existing authorities.”

Rep. Brad Schneider (D-IL) attended today’s hearing and listened in as his bill was reviewed.

H.R. 2063, the Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017, authored by Rep. Brad Schneider (D-IL), aims to improve provider understanding of pain management treatment guidelines and best practices, early detection of opioid addiction, and the treatment and management of opioid-dependent patients by requiring 12 hours of continuing medical education on the topic every three years.

While Dr. Andrew Kolodny, Co-Director, Opioid Policy Research, Brandeis University, identified some concerns he has with H.R. 2063 in its current form, he stressed he is “strongly in favor of mandatory education for DEA registrants who intend to prescribe more than a 3-day supply of opioid analgesics…”. He also encouraged the legislation enact “strict firewalls between pharmaceutical company marketing and medical education.”

H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, authored by Reps. Mark DeSaulnier (D-CA) and Buddy Carter (R-GA), will help pharmacists detect fraudulent prescriptions. H.R. 4275 will help develop and disseminate materials, giving pharmacists greater understanding and ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion.

Mr. Richard Logan, Owner, L&S Pharmacy, speaking on behalf of the National Community Pharmacists Association (NCPA), stated, “NCPA supports such an effort to bring greater clarity and education to other health care providers and patients regarding a pharmacist declining to fill a controlled substance. Even though pharmacists currently have the right to decline filling any controlled substance as part of their corresponding responsibility per the Controlled Substances Act, it is important to educate patients and entities such as insurance companies and pharmacy benefit managers on such circumstances.”

For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click here.

To learn more about the committee’s ongoing efforts to combat the opioid crisis, click here.


Press Release