The Senate’s draft user fee package, unveiled Tuesday (May 17), allows two interchangeable biosimilars to share exclusivity, if they are approved on the same day, and clarifies that FDA can tentatively approve an interchangeable biosimilar while a first interchangeable product’s exclusivity period is pending.
There is no similar provision in the House user fee package, which will be marked up by the Energy & Commerce Committee Wednesday (May 18). The draft Senate bill also aims to improve the Purple Book by aligning certain reporting requirements for biologics with the reporting requirements for drugs, including by requiring sponsors of biologics license applications to let FDA know when they withdraw a product from the market, and to submit a one-time report confirming their products listed in the Purple Book are still available for sale. The bill also would require FDA to update the Purple Book to reflect changes to the status of a biologic product.
Senate health committee Chair Patty Murray (D-WA) and ranking Republican Richard Burr (NC) released their draft legislation, FDA Safety and Landmark Advancements (FDASLA) Act, on Tuesday. They plan to introduce and mark up a final version in the coming weeks.
The bill reauthorizes FDA’s prescription and generic drug, medical device and biosimilars user fee agreements. It also contains measures that aim to strengthen FDA’s oversight of cosmetics and dietary supplements, improve regulation of laboratory-developed tests, and increase safe disposal of opioids and other drugs with serious risks.
Last month, Murray called for members of the Senate health committee to build on past efforts to lower drug prices and stop drug makers from blocking cheaper generic drugs from coming to market as part of the committee’s user fee discussions.
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