In their recent commentary, Furberg et al1 make recommendations to improve Food and Drug Administration (FDA) and current drug safety regulations. The authors fail to address 2 critical points: (1) the need to improve mechanistic assessments of new drug safety prior to FDA approval and (2) the need for sweeping changes in practice of medicine.
Their proposal for empirical determination of drug safety through postmarketing study commitments and for FDA authority over their conduct may improve our long-term understanding of safety. However, this approach assumes that a safety issue has already been identified by the time of FDA approval. Also, it benefits only those who begin using the product after such safety studies are completed, results published, and clinical care modified.
Cross JT. Sweeping Changes to Food and Drug Administration and Drug Safety Regulations. Arch Intern Med. 2007;167(7):732. doi:10.1001/archinte.167.7.732-a