After winning overwhelming and swift approval in the House and Senate, the Food and Drug Administration Safety and Innovation Act (S. 3187), which is expected to generate $6 billion over five years from user fees to fund the agency, has been signed into law by President Barack Obama (D). The bill reauthorizes user fees for another five years. Among other matters, the legislation imposes certain deadlines on the Food and Drug Administration (FDA), including one that reduces the time the agency has to respond to a citizen petition seeking to stay a pending generic-drug application and another that sets a limit on the time FDA has to respond to petitions relating to genericdrug approval. Also intended to speed the approval of cheaper generic drugs are requirements that, for the first time, impose user fees on generic-drug makers.
Provisions that were excluded from the measure include supply chain track-and-trace requirements as well as a prohibition on brand-name manufacturers with a risk evaluation and mitigation strategy from denying drug samples to generic-drug manufacturers. Exclusivity periods under the law are extended to new qualified infectious disease products, and programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations have been made permanent. Other provisions address prescription drug shortages, direct FDA to expand its use of foreign clinical data and give the agency additional authority over medical devices. See The Washington Post, June 26, 2012; The Hill, July 9, 2012.