Drugs

No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

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 (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 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.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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