by Todd M. Nesbit
March 12, 2014
The Food and Drug Administration (FDA) recently proposed a new rule intended to disseminate drug safety information more quickly to physicians and the public. The “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule would give Abbreviated New Drug Application (ANDA) holders of approved generic drugs more independence in enacting a safety-related labeling change. The FDA argues that this rule will allow ANDA holders to more actively participate in the updating of safety-related labeling. Given that 80 percent of all prescription medications dispensed are generic, adequate dissemination of drug-safety information for generic drugs is an important matter. Yet, the analysis presented in the Preliminary Regulatory Impact Analysis (PRIA) fails to substantiate the claim of the rule’s beneficence. Given the potential impact on consumer health, this regulation deserves a more thoughtful analysis. Further, it is advisable that the FDA compare and contrast the proposed rule reasonable alternatives.