Abstract:: All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench‐marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.
1 Center for Inflammatory Bowel Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts
2 Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota
*Reprints: Center for Inflammatory Bowel Disease, BIDMC, 330 Brookline Ave., Boston MA 02215
Received 9 February 2011; Accepted 21 February 2011
Published online 11 April 2011 in Wiley Online Library (wileyonlinelibrary.com).