The FDA lacks reliable data on tracked safety issues and postmarket studies related to drug applications needed to meet certain postmarket safety reporting responsibilities, according to a report by the United States Government Accountability Office.
Here are six points:
1. The FDA's Center for Drug Evaluation and Research receives requests for fast track designation and breakthrough therapy designation, two of the agency's expedited programs for the review of new drugs.
2. About a quarter of the drug applications CDER approved for the U.S. market from 2006 to 2014 used at least one expedited program.
3. These applications include new drug applications, biologic license applications and efficacy supplements.
4. The FDA tracks potential safety issues using an internal database, however, the GAO has found problems with the completeness, timeliness and accuracy of the database.
5. Additionally, FDA does not have plans to use the data to enhance its oversight of the expedited programs, such as determining if drugs that used an expedited program were later associated with tracked safety issues.
6. The GAO recommends that the FDA develop plans to correct problems with its postmarket safety data and ensure that these data can be easily used for oversight.