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Senators Braun, Manchin Introduce Bipartisan Bill to Address Gaps in Opioid Approval Process

Senator Mike Braun
Senator Joe Manchin (D-W.V.)

On Thursday, U.S. Senators Mike Braun and Joe Manchin (D-WV) introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act which would allow the Food and Drug Administration (FDA) to deny a new drug application for an opioid analgesic drug on the basis of the drug not being clinically superior to other commercially available drugs. FDA Commissioner Robert Califf requested this additional authority to aid the FDA as it considers whether to approve new and more powerful opioids.

“The opioid epidemic has permeated every corner of Indiana and left communities devastated from the loss of life and opportunity. Drug overdoses are now one of the most common causes of death in Indiana. I’m proud to join with Senator Manchin on this bipartisan solution to slow the growth of the crisis by tightening up the FDA approval process for opioid drugs by taking efficacy into account when approving new ones,” said Senator Braun.

“Last year, more than 107,000 Americans and 1,490 West Virginians died from drug related overdoses,” Senator Manchin said. “It’s heartbreaking to lose so many of our fellow Americans and West Virginians to drug overdoses and it’s far past time for Congress to take comprehensive, meaningful action to address this crisis. 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. I’m proud to introduce this bipartisan bill with my colleague Senator Braun and encourage my colleagues on both sides of the aisle, and FDA leadership, to support this critical step in combating the drug epidemic that continues to ravage our nation.”

The EFFECTIVE Act would allow the FDA to deny a new drug application for an opioid analgesic drug on the basis of the drug not being clinically superior to other commercially available drugs. This bill would provide further authority to the FDA so they can review the public health impact of every new opioid approval and deny new drug applications even if the pharmaceutical company sponsored clinical trials show that a particular drug is “safe.” Importantly, this bill fulfills a request from Dr. Califf to ensure that the FDA is able to fully implement the recommendations from the National Academy of Sciences, Engineering and Medicine’s (National Academies) 2017 report, Pain Management and the Opioid Epidemic. Dr. Califf asked the National Academies to complete this report to highlight what more the FDA could be doing to address the drug epidemic. However, five years later, no meaningful progress has been made on any of the recommendations made in the report.