The US Senate on Thursday, August 3rd passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.1 According to RAPS, a spokesman for President Donald Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”
The negotiation on the reauthorization of the House Bill began more than two ears ago but was finally passed by the Senate with a vote of 94-1. The bill permits FDA to collect industry user fees through 2022, allowing payment for timely reviews of new medical products.
Industry groups commended the Senate’s passage of the bill while the Project on Government Oversight criticized the close relationship between FDA and industry.
What’s in the user fee reauthorization bill?
PDUFA
The Prescription Drug User Fee Act (PDUFA VI) focuses on “pre-market reviews, postmarket safety, regulatory decision tools and other ways DA is preparing for the future of drug development.”1
The agreement also looks to further incorporate the patient voice into drug development.
GDUFA
The Generic Drug User Fee Amendments (GUDFA II) has created a new user fee structure which the goal to help small businesses as well as speed the review of generic drugs.
MDUFA
The Medical Device User Fee Act (MDUFA IV) increases user fees for device manufactures in exchange for reducing the time to decisions for premarket applications and submissions.
BsUFA
The Biosimilar User Fee Act (BsUFA II) allows for more communication between FDA and biosimilar applicants by adding 60 days to the review timeframe. Furthermore, the next BsUFA could allow for sponsors to request a written response to questions rather than a face-to-face meeting.
Other
The bill requires that FDA publish annual information regarding the previous year’s inspections of drug or medical device facilities. Also, it revises requirements for performance reports “under all the user fee programs to include require[d] quarterly publication of information regarding guidance and meetings.”1
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