On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would reauthorize the fee system for the FDA’s approval of drugs, medical devices, generic drugs, and biosimilars. Recognizing both the must-pass nature of the bill and the partisan climate in Congress right now, the committee and its staff smartly managed to keep the bill fairly clean, adding few non-funding related provisions relative to some past user fee agreements (UFAs). Still, the full text clocks in at just under 200 pages, including amendments.
I review some of the key provisions below.
Eschewing The President’s Proposed User Fee Hikes
Most importantly, the bill reauthorizes the different user fees drug and device sponsors pay the agency in exchange for review of their products. What is most notable about this set of provisions, which make up Titles I through IV of the bill, is perhaps what is not there. President Trump’s budget blueprint aimed to decrease general funding for the FDA and make up for the shortfall by doubling the size of user fees from industry. This bill does not do that and instead moves forward with the fee levels that were negotiated between the FDA, industry, and consumer groups prior to the release of that blueprint.