Drugs that receive “fast track” or accelerated approval status from the US Food and Drug Administration (FDA) are associated with increased safety-related label changes after approval, according to data published in the BMJ.

A recent retrospective cohort study examined whether drugs approved through the FDA’s expedited development and review pathways have different rates of safety-related label changes after approval compared with drugs approved through standard pathways. Drugs may receive accelerated approval status from the FDA if they treat serious or life-threatening conditions or meet unmet medical needs.

FDA public records from January 1997 to April 2016 were examined, and among 382 eligible new drugs, 135 (35%) had undergone expedited development or review. These were matched with nonexpedited drugs in the same therapeutic class that were approved within 3 years of the expedited drugs. Matches were available for 96 (71%) of the expedited drugs. The primary outcome was the number of times the safety section of a label, including the boxed warnings, contraindications, warnings, precautions, or adverse reactions, was changed during the time the drug was on the market.

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The matched pairs were associated with 1710 safety-related label changes during the study period. The rate of safety-related label changes per drug per year was 0.94 for expedited pathway drugs compared with 0.68 for nonexpedited pathway drugs (rate ratio, 1.38; 95% CI, 1.25-1.52). Expedited drugs had a 48% higher rate of changes to boxed warnings and contraindications, which are the 2 most clinical important categories of safety warnings.

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Study limitations included the failure to find matches for 29% of expedited drugs, thus excluding them from the analysis, and the inability to provide qualitative analysis of the type of changes made.

These findings suggest that although there is great value in expediting certain drugs, it is important to ensure that these pathways are not overused and that there is sufficient post-approval monitoring.


Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017;358:3837