Postmarket Drug Safety−Related Actions Before and After the US Food and Drug Administration Amendments Act

Was the 2007 Food and Drug Administration (FDA) Amendments Act (FDAAA) associated with differences in time to first FDA postmarket drug safety−related action, including withdrawals, boxed warnings, and safety communications?In this cross-sectional analysis of 560 therapeutics approved by FDA between 2001 and 2019, a total of 130 (23.2%) experienced postmarket safety-related actions during a median (IQR) follow-up period of 12.1 (7.8-18.2) years. Compared to pre-FDAAA approvals, there was no statistically significant difference in time to first postmarket drug safety−related action post-FDAAA.The enhanced drug safety−related regulatory authorities of FDAAA were not associated with differences in time to first postmarket safety-related action except for among therapeutics with actions within the first 5 years after approval for which median time to first action was shorter post-FDAAA.

Corresponding Author: Joseph S. Ross, MD, MHS, Section of General Internal Medicine and the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT 06520-8093 (joseph.ross@yale.edu).

Link to the article in your story

We encourage you to link out to this article in your story using the link below. It includes an access token that will give free access to the article for your readers up to one year after publication. (The link will be live after the article publishes and embargo is lifted.)

Please see the article for additional information, including full author list, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

Need more information? Contact us.