Ahead of its summer recess, the US Senate today followed its House counterparts and passed a bipartisan bill to reauthorize FDA user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. 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 Senate’s passage of the House bill by a vote of 94-1 — Bernie Sanders (D-VT) was the only vote against — comes more than two years after negotiations on the reauthorization began. The bill would allow FDA to collect industry user fees through 2022 to help pay for timely reviews of new medical products, in some cases expedite the reviews of certain products and to disclose its progress in meeting new goals.
Industry groups praised the Senate’s passage of the bill, though the Project on Government Oversight criticized the cozy relationship between FDA and industry, as well as one of the bill’s provisions that “could provide patients and regulators with less detailed and timely warnings about potentially deadly hazards associated with medical devices.”
Below is a breakdown of some of the highlights from each of the user fee reauthorizations and other provisions.
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) focuses on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.
In addition, the agreement seeks to further incorporate the patient voice into drug development, enhance the use of real-world evidence, improve benefit-risk assessments and expand postmarket safety data and evaluations.
The second iteration of the Generic Drug User Fee Amendments (GUDFA II), which creates a new user fee structure and aims to help small businesses, also will speed the review of generic drugs and increase interactions between the agency and generics developers working on complex generics.
The fourth iteration of the Medical Device User Fee Act (MDUFA IV) would increase user fees for device manufacturers by more than $320 million over the next five years in exchange for reducing the average total time to decisions for premarket applications and 510(k) submissions, among other provisions.
The second iteration of the Biosimilar User Fee Act (BsUFA II) would allow for additional communication between FDA review teams and biosimilar applicants in the form of presubmission meetings, mid-cycle communications and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate for additional interactions. In addition, the next BsUFA would allow, in certain circumstances, sponsors to request a written response to questions rather than conduct a face-to-face or teleconference meeting.
The bill also requires that FDA annually publish information regarding the previous year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process.
In addition, the bill revises requirements for performance reports under all the user fee programs to include requiring quarterly publication of information regarding guidance and meetings.
Among the amendments adopted by the House Energy and Commerce Committee were proposals for risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, a pilot project for active surveillance of medical devices and a manager’s amendment that provides a number of technical changes and strengthens the labeling requirements for over-the-counter hearing aids under the reauthorization bill.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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