Senators Introduce Bill to Address FDA’s Opioids Approval Process

Last week, Senators Joe Manchin (WV) and Mike Braun (IN) introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act, which would provide the Food and Drug Administration (FDA) with authority to review the public health impacts of opioid approvals and deny new drug applications for opioid analgesics if the product is not clinically superior to other commercially available products. The bill was developed in response to requests by FDA Commissioner Dr. Robert Califf to provide the agency with additional legal authority to implement recommendations outlined by the National Academy of Sciences, Engineering and Medicine in their 2017 report, Pain Management and the Opioid Epidemic. In a statement Senator Manchin said, “The EFFECTIVE Act would address gaps in the FDA’s approval process by allowing them to take efficacy into account when approving new opioids to the market, limiting the approval of redundant, more harmful drugs.”

Articles & Resources

Senator Joe Manchin – Manchin, Braun Introduce Bipartisan Bill to Address Gaps in Opioid Approval Process


Lawmakers Request White House Implement Opioid Commission Recommendations

Last week, Representative David Trone (MD-6) and Senator Edward J. Markey (MA) sent a letter to President Joseph Biden requesting that the Administration review the U.S. Commission on Combating Synthetic Opioid Trafficking’s final report issued in February 2022 and take executive action to enact Commission’s recommendations. In their letter, the lawmakers urge the Administration to implement key recommendations from across five pillars: policy coordination and implementation, supply reduction, demand reduction and public health, international cooperation, and research and monitoring. A copy of the letter can be found here, and a copy of the Commission’s final report can be found here.

Articles & Resources

Congressman David Trone – Trone, Markey Urge President Biden to Act on Opioid Crisis by Enacting Recommendations from Opioid Commission Report

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

American Academy of Pediatrics – American Academy of Pediatrics Recommends Non-Stigmatizing Terminology for Substance Use in Policy Statement

American Psychiatric Association – New Study Tests a Curriculum for Medical Students on Detecting and Treating Opioid Use Disorder

Bloomberg Government – Tentative $161.5M Settlement Reached in WVa Opioid Trial

FDA – Orphan Drug Designations and Approvals – buprenorphine

HCP Live – Nora D. Volkow, MD: Advancing Clinical Research for Treating Use Disorders

JAMA Network Open – Association of Opioid Dose Reduction With Opioid Overdose and Opioid Use Disorder Among Patients Receiving High-Dose, Long-term Opioid Therapy in North Carolina

Kaiser Health News – The Blackfeet Nation’s Plight Underscores the Fentanyl Crisis on Reservations

MedCity News – Why decentralization & digitization could be the key to unlock the future of addiction care

Northern Public Radio – Rural community college helps bring opioid crisis conversation out into the open

Senator Maggie Hassan – Hassan, Shaheen & Pappas Participate in Roundtable Discussion on Substance Use Prevention and Treatment Efforts with ONDCP Director Gupta

The Hill – Bipartisan lawmakers target addiction crisis by boosting non-opioid pain management

The White House – FACT SHEET: Biden-⁠Harris Report: “Advancing Equity Through the American Rescue Plan”

Trust for America’s Health – U.S. Experienced Highest Ever Combined Rates of Deaths Due to Alcohol, Drugs, and Suicide During the COVID-19 Pandemic

UCLA – Opioid Addiction Crisis in United States Linked to Poor Working Conditions and Unemployment

United Nations – Neonatal abstinence syndrome: UNODC and experts discuss support for mothers and infants exposed prenatally to synthetic drugs

USC – Electronic ‘Nudges’ May Improve Safety in Opioid Prescribing Among California Doctors, Study Finds

UVA Health – New App Helps People Struggling With Opioids

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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