The Senate’s (HELP) Committee is holding a special session to review and revise a bill that would make changes to Food and Drug Administration (FDA) policies. This session is known as a markup.
Titled the FDA Safety and Landmark Advancements (FDASLA) Act, this bill being marked up would reauthorize the existing laws that allow the FDA to get payments from companies for reviews of prescription drugs and medical devices. These user fees are steered toward keeping the FDA’s review operations adequately staffed to prevent delays in decisions on applications. (This 2021 report from the Congressional Research Service provides more details on the Prescription Drug User Fee Act (PDUFA.)
Congress reauthorizes the PDUFA law every five years. The current authorization expires in September, effectively setting a tough deadline for Congress. The reauthorization of the PDUFA law also provides a vehicle for members of Congress to make other changes in FDA policies. Among the proposals included in the draft bill are attempts to give the FDA more clear authority to compel drugmakers to prove that drugs cleared by accelerated approval truly offer a significant benefit to patients.
When/Where: 10:00 a.m EST, Wednesday, June 8, 2022 (online)
Check this link on the HELP page for the webcast.
See the HELP committee’s press release and section-by-section explainer of the bill.