The U.S. Senate has passed the FDA Reauthorization Act of 2017 by a vote of 94-1. Sen. Bernie Sanders (D-VT) was the only "no" vote. The bill reauthorizes the Food and Drug Administration to collect fees from companies that make prescription drugs, generic drugs, medical devices and biosimilars for the next five years. The user fees will allow for faster product review and expedited approvals from the FDA.
"Since the passage of the first Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played a critical role in the drug approval process," said Debbie Hart, president and CEO of BioNJ. "The overwhelmingly bipartisan support for this legislation in both the House and the Senate is a clear indication of its importance. With the reauthorization of the user fees, the groundbreaking 21st Century Cures Act passed last year can now be fully implemented. It's truly a major victory for patients who depend upon access to innovative lifesaving drugs and therapies."
The bill also says FDA must annually publish the previous year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process, according to Regulatory Focus. And the bill revises requirements for performance reports to include quarterly publication of information regarding guidance and meetings. Read the RAPS story.
As previously reported, if this bill didn't pass, industry representatives told members of the Senate Committee on Health, Education, Labor & Pensions that the FDA would likely see more than 3,000 layoffs.