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M 03: Analysis of Postmarket Safety Labeling Changes: Comparison of Expedited Versus Standard NDA Approvals

Poster Presenter

      Adam Chin

      • Pharmacy Student, President-Elect, SSHP
      • Touro College of Pharmacy
        United States


Recently, GAO reported FDA has not determined whether drugs approved via expedited process are associated with safety issues at rates different from drugs approved via standard processes. Our objective was to compare rates of labeling changes of drugs approved via expedited vs. standard mechanisms.


FDA approved drugs from 2007-2015 with expedited approval were reviewed for safety-related labeling changes using Rates of postmarket safety label changes for these drugs were compared to rates of postmarket safety label changes for a sample of standard approval drugs.


A total of 119 drugs were identified as approved via the FDA’s expedited processes: accelerated approval, breakthrough designation and fast track. Anti-infective and oncology medications were the largest categories of medication which were approved via expedited processes. Significant safety issues were defined as those requiring labeling changes. 25 drugs were approved via the FDA’s accelerated approval process from 2007-2015; of these, 13 (52%) were found to have significant safety issues. 15 drugs were approved via the FDA’s Breakthrough designation process from 2012-2015; of these, 6 (40%) were found to have significant safety issues. 79 drugs were approved via the FDA’s Fast Track process from 1998-2015; of these 42 (53%) were found to have a post marketing safety issues that required a label change. In total, 61/119 (51.3%) of drugs that were approved through one of the FDA’s accelerated approval processes were found to have a postmarket safety issue that required a labeling change. A sample of 119 drugs approved through the standard approval process were found to have 65/119 (54.6%) labeling changes due to postmarket safety issues. A comparative assessment of expedited vs standard approval drugs using Chi Square analysis revealed no statistically significant difference between the rate of safety issues between the two groups. Additionally, there were no statistically significant differences between rates of safety labeling changes for the three types of accelerated approvals studied in this analysis.


Drugs that were approved via an expedited process were not found to have significantly more postmarket safety issues as compared with drugs that were approved via the standard process. In fact, slightly less labeling changes were observed. The route of expedited approval also did not seem to affect the rate of safety labeling issues. The need for expedited drug approval to address unmet medical needs in the treatment of serious conditions must be balanced by a requirement that the benefits justify the risks.

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