Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar products. In particular, the proposed legislation reauthorizes the FDA’s biosimilar user fees through fiscal year 2022. The bill includes several amendments to the biosimilar user fees, including the elimination of user fees for supplements to biosimilar applications and biosimilar manufacturing facilities, and an annual fee will be assessed on holders of approved applications for biosimilars. The bill also sets the annual amount of revenue that must be generated by fees.
The FDARA was introduced in the Senate and is currently on the Senate Legislative Calendar. Without reauthorization, the FDA’s user-fee programs is set to sunset on September 30, 2017.