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# No FDAAA Difference in Time to 1st Postmarket Safety Action: Study
- URL: https://www.fdaweb.com/no-fdaaa-difference-in-time-to-1st-postmarket-safety-action-study/
- Published: 2025-12-10T12:00:00.000Z
- Updated: 2026-09-14T15:28:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160363

Researchers from several universities say the enhanced safety-related regulatory authorities in the FDA Amendments Act (FDAAA) of 2007 were not associated with differences in time to first postmarket safety-related action. Writing in *JAMA Internal Medicine*, the researchers [said](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2842413?ref=fdaweb.com) (subscription required) that among therapeutics with postmarket safety-related actions within five years of approval, the median time to first action was shorter post-FDAAA implementation.

The researchers conducted a cross-sectional study of 560 therapeutics approved by FDA between 1/1/2001 and 12/31/2019, and followed up through 12/31/2024\. The main outcome and measure was time to first FDA postmarket drug safety-related action, a composite of withdrawals due to safety concerns, incremental Boxed Warnings, and safety-related communications.

An *American Journal of Managed Care* (AJMC) review of the study [says](https://www.ajmc.com/view/postmarket-drug-safety-timelines-largely-unchanged-after-fda-amendments-act?ref=fdaweb.com) that among the 91 therapeutics with safety events within the first five years, the median time to first action was 3.1 years pre-FDAAA and 1.8 years post-FDAAA, reflecting earlier regulatory response after implementation of the law. The authors said this finding indicates the enhanced safety-related regulatory authorities of the FDAAA were effective. However, the review says, the authors emphasized that the study was not designed for causal inference, and other time-varying factors may have contributed.

AJMC says the analysis also examined 260 therapeutics approved post-FDAAA after the 2013 introduction of the breakthrough therapy designation. It says several drug and regulatory characteristics were associated with time to first postmarket safety-related action:

- small-molecule drugs had shorter times to safety actions than biologics;
- breakthrough therapy and fast-track designation were associated with faster safety actions;
- prolonged regulatory review was also associated with shorter times;
- FDAAA-mandated postmarket study requirements at approval were linked to faster safety-related actions; and
- orphan-designated therapeutics had significantly longer times to first safety action, consistent with challenges in detecting safety signals in small populations.