FDA is Issuing More Postmarketing Requirements, but Challenges with Oversight Persist

FDA approves new drugs for sale in the United States through the new drug application (NDA) review process. FDA requires all new drugs to undergo clinical testing to demonstrate their safety and efficacy prior to approval. However, premarket clinical trials may not always identify or fully characterize risks. Postmarketing research can provide additional information about the risks, benefits, and optimal use of an approved drug. In 2006, the Office of Inspector General (OIG) found that FDA could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that FDA lacked an effective monitoring system for postmarketing studies. Since then, the Food and Drug Administration Amendments Act (FDAAA) expanded FDA's authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance. This study follows up on OIG's previous work in light of FDA's expanded authority.