FDA Deficient in Postmarket Drug Surveillance, GAO Reports

The FDA does not effectively track potential safety issues with drugs granted expedited approval after they reach the market, according to a report from the US Government Accountability Office (GAO). Between 2006 and 2014, the FDA’s Center for Drug Evaluation and Research (CDER) received about 1000 requests for fast-track and breakthrough therapy designation, both of which require manufacturers to submit formal requests for expedited review. When the FDA grants a new drug accelerated approval, it is required to monitor and report on potential safety issues such as serious adverse events and medication errors. This is because expedited drugs are not subject to the standard review process, so there is less information available on their clinical effectiveness, as well as some risk. The FDA keeps track of these potential safety issues through postmarket study data captured in its internal database known as the Document Archiving, Reporting, and Regulatory Tracking System. However, CDER’s internal evaluations of the postmarket study data collected in this database showed that they contained inaccuracies and were outdated, partly as a result of delays in staff review of submissions from drug manufacturers. In fact, more than half of drug sponsors’ submissions involving about 1400 postmarket studies required or requested from the FDA between March 2008 and September 2013 were delayed or overdue. Furthermore, GAO uncovered that the all of the FDA’s tracking data has to be entered manually, which essentially renders the software inadequate. In addition, the database cannot be queried to determine characteristics of tracked safety issues, such as the population affected, therapeutic area, or past regulatory actions. In light of this, the GAO report concluded that the “FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.” The GAO recommended that the FDA develop plans to correct problems with its postmarket safety database and ensure that the data can be easily used for oversight. The US Department of Health and Human Services (HHS) agreed with GAO's recommendations and provided additional information on FDA's postmarket safety efforts. The GAO also suggested that HHS order the FDA commissioner to develop a comprehensive plan to address the identified problems, and that the FDA upgrade its information technology system. Reference US Government Accountability Office. FDA expedites many applications, but data for postapproval oversight need improvement. http://www.gao.gov/assets/680/674183.pdf. Published December 2015. Accessed January 27, 2016.