April 30, 2021
By Ramona du Houx
U.S. Senator Angus King (I-Maine) joined Senators Joe Manchin (D-W.Va.) and Shelley Moore Capito (R-W.Va.) to introduce the FDA Accountability for Public Safety Act, which would ensure experts are heard when the Food and Drug Administration (FDA) considers new, dangerous opioid medications. In 2020, over 90,000 Americans died from drug overdoses – including more than 500 in Maine – and it is likely that 51 percent of those deaths on the national scale involved opioids or synthetic opioids.
“2020 was Maine’s deadliest year on record for drug overdoses – and so far, 2021’s numbers look even worse. The epidemic of substance use disorders continues to devastate communities throughout Maine and across the country,” said Senator King. “I’m for any solution that helps us address this crisis – including increasing accountability at the FDA to prevent dangerous, addictive opioids from coming to market in the first place. We’ve lost too many loved ones and neighbors to overdoses; it’s time to revisit the process that makes these preventable deaths possible.”
Currently, the FDA convenes an advisory committee of scientific experts when a matter is of significant public interest, highly controversial, or in need a specific type of expertise. In recent years, however, the FDA has either ignored its advisory committee’s recommendations or failed to seek its counsel. In 2013, the FDA approved the very powerful opioid, Zohydro, despite the advisory committee voting 11-2 against approval of the drug due to their concerns about the safety of the drug. And since that time, two new opioid medications, Targiniq and Hysingla, have been approved without an advisory committee meeting at all.
The FDA Accountability for Public Safety Act would:
- Strengthen the language included in CARA to ensure that both new opioids and already-approved opioids seeking approval for expanded labeling are subject to advisory committee review and recommendation before the FDA makes a decision about approval.
- Require the FDA Commissioner to make the final decision regarding drug approval if the advisory committee does not approve of an opioid due to concern over consumer health and safety.
- Require the FDA to submit a report to Congress that includes medical and scientific evidence regarding patient safety that clearly justifies why they ignored the advisory committee’s recommendation. It must also include any conflicts of interest that FDA officials involved in the decision may have.
- Prohibit the marketing of the drug until the report is submitted to Congress.
Senator King has made combating the opioid crisis one of his highest priorities in Washington. Since the pandemic has separated Americans from their loved ones and made it more difficult to access resources, Senator King has worked to connect with the people of Maine virtually and raise awareness about resources available for support. Earlier this year, he urged President Biden to request robust funding and increase the federal investment in our nation’s response to the ongoing opioid and substance use disorder (SUD) epidemic.
In September 2020, he introduced a bipartisan resolution to officially recognize September as “National Alcohol and Drug Addiction Recovery Month” and focused his September podcast on recovery from SUDs amid the pandemic.
In May 2020, he participated in a video teleconference with Maine Alliance for Addiction and Mental Health Services to connect with their staff that work with Maine’s behavioral health organizations and help those coping with substance use disorders and mental health challenges.
To encourage additional supports, Senators King and Tim Kaine (D-Va.) led a group of 20 Senators in a letter to Senate leadership to call for increased investments in mental and behavioral health in future coronavirus relief legislation. Senator King voted for the SUPPORT for Patients and Communities Act in 2018, sweeping opioid legislation which passed with overwhelming bipartisan support and included several King-backed provisions to help Maine families and communities affected by the opioid crisis. The legislation was the result of months of bipartisan hearings and discussions on the opioid crisis.