US Senate Passes FDA User Fee Package

On Aug 4, 2017

The United States Senate passes H.R. 2430, the FDA Reauthorization Act of 2017, by a vote of 94-1 (Sen. Bernie Sanders of Vermont was the lone ‘no’ vote). The bill authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce drugs and biologics. The user fees allow for swifter 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.”

According to Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood, “The user fee program reauthorization package passed by the Senate is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

This is the sixth reauthorization of PDUFA, which extends it through September 2022.

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