The FDA, Regulation, and the Risk of Stroke

Abstract

When Jane Henney, commissioner of the Food and Drug Administration (FDA), announced on October 10, 2000, the agency's intention to have products containing phenylpropanolamine withdrawn from the market, another chapter — perhaps the final one — for this over-the-counter drug was opened. The FDA acted even before the results of the work on which the decision is based could be published. In this issue of the Journal, Kernan et al. report the results of an exemplary epidemiologic effort, the Hemorrhagic Stroke Project.¹ This project was designed in response to the FDA's concern about the safety of phenylpropanolamine, which began in . . .