FDA Amendments Act – HPM Issues Detailed Summary and Analysis

Hyman, Phelps & McNamara, P.C. issued a detailed summary and analysis of the FDA Amendments Act (“FDAAA”), which President Bush signed into law on September 27, 2007. FDAAA amends both the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, the new law provides FDA with new funding and oversight of drug safety. The law significantly changes FDA’s handling of postmarket drug product safety issues and will have considerable short- and long-term effects on drug manufacturers.

FDAAA includes 11 titles, the first 5 of which reauthorize drug and medical device user fee and pediatric-related programs through Fiscal Year 2012. Title III also amends the FDC Act to create new provisions to provide incentives to medical device manufacturers to develop devices for pediatric patients and to provide FDA with new authority to review and regulate such devices. Titles VI-VIII establish a new private-public partnership intended to modernize medical product development and enhance product safety, amend the FDC Act with respect to certain conflict of interest issues among FDA advisory committee members, and establish databases for clinical trial registries and results. Title IX, perhaps the longest reaching FDAAA provision, includes various programs intended to improve the postmarket safety of drugs, including giving FDA the authority to impose Risk Evaluation and Mitigation Strategies. This title also modifies the citizen petition process with respect to petitions having the potential to delay approval of generic drug products. Title X, which concerns food safety, creates a reportable food registry to help track problems in the food supply and to allow for a rapid FDA and industry response. Finally, Title XI includes several miscellaneous provisions intended to, among other things, improve antibiotic access and innovation.