Bipartisan Bills Seek to Overhaul FDA Opioid Regulations

WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how the Food and Drug Administration approves and manages opioid medications.

“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug-related overdoses,” Manchin said in a written statement. 

“It’s far past time for Congress to take comprehensive, meaningful action to address the crisis,” he continued. “I encourage my colleagues on both sides of the aisle, along with FDA leadership, to support these critical, commonsense reforms to combat the drug epidemic that continues to ravage our nation.”

According to the senators, the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (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 would help provide further authority to the FDA so it can review the public health impact of every new opioid medication approval and deny new drug applications even if the pharmaceutical company–sponsored clinical trials apparently show “safety” of the drug, they said.

“These commonsense pieces of legislation would strengthen scientific review throughout the opioid approval process, prioritize public health impacts over pharmaceutical interests and hold the FDA and its leadership accountable for their role in addressing the drug epidemic,” the senators wrote.

“The opioid epidemic continues to devastate communities and tear a hole through the Midwest,” Braun said in a written statement. “I’m proud to join with Sen. Manchin to introduce these three bipartisan bills to overhaul the FDA approval process for opioid medications. Opioid drugs are different from other pharmaceuticals, and carry very different risks, and how we approve and manage these drugs must change as well.”

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