On May 10, the Food and Drug Administration (FDA) issued a Federal Register notice requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under section 351(k) of the Public Health Service Act (PHSA).1 FDA is requesting comments relating to FDA’s key principles for development of a 351(k) user fee program and FDA’s proposed 351(k) user fee goals for this program.2 FDA is accepting comments on the 351(k) user fee program through June 9, 2011.3

Background

The Patient Protection and Affordable Care Act (PPACA)4 amended the PHSA to create a regulatory approval pathway for abbreviated biologic applications.5 In doing so, PPACA also amended the prescription drug user fee provisions under section 735 of the Federal Food, Drug, and Cosmetic Act6 (FFDCA) to include 351(k) applications. Under PPACA, the user fee for a Biologic License Application (BLA) is the same regardless of whether the application is submitted under the new 351(k) approval pathway or the preexisting 351(a) approval pathway through September 2012.7 However, PPACA directs FDA to develop recommendations for a user fee program specifically for 351(k) applications for Fiscal Years 2013–2017.