The U.S. Government Accountability Office (GAO) has released the results of its study of the Food and Drug Administration’s fast-track approval process for new drugs and says the agency has failed to track safety issues and conduct postmarket studies, adversely impacting the FDA’s regulatory oversight of postmarket drug safety.
Currently, the FDA has four expedited programs for drug approval: accelerated approval, breakthrough therapy designation, fast track designation and priority review. These four programs are designed to help speed the development and review of new drugs for serious conditions.
The GAO study found that from October 2006 to December 2014, there were approximately 1,000 requests from drug makers for either fast track or breakthrough therapy designation. Of the 770 requests for fast-track designation, the FDA approved two-thirds of the requests. Of the 220 requests for breakthrough therapy designation, more than half were rejected. Overall, one in four drug applications approved by the FDA used at least one expedited program.
The FDA is required to monitor a drug’s safety after it has been released to the market and report on any potential safety issues, such as serious adverse reactions or dosage errors which may necessitate warning labels for the public or withdrawal from the market. The FDA can request or require that a manufacturer conduct postmarket safety studies after a drug has received approval. The agency must then provide the proper oversight of those studies to confirm a drug’s clinical benefit.
The GAO study found that the “FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.”
In addition, the study noted that although the FDA has taken a few steps to remedy the data problems, the agency does not have comprehensive plans for dealing with these issues.
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