GAO Report Finds Gaps in the FDA’s oversight of Drug Safety
GAO Report Finds Gaps in the FDA’s oversight of Drug Safety
The Government Accountability Office released a report last week that summarized a list of shortcomings in how the Food and Drug Administration tracks drug safety issues.
In recent years, the FDA has sped up the process of approving many new drugs through expedited programs. Over 1,000 expedited requests were received from October 2006 to December 2014. Just last year, the FDA approved 45 new drugs.
This was the highest number of drugs approved in 19 years, with half of those drugs receiving specialized reviews so that they could reach the market faster.
As new drugs continue to be expedited, the GAO found that the FDA often fails to properly track important safety issues of those drugs.
Between 2008 and 2013, the FDA was late in reviewing more than half of the 1,400 follow up studies it had required of drug manufacturers. These post-market studies are crucial in finding out important safety issues that arise after patients start taking the drugs. These shortcomings could ultimately put more consumers at risk.
Furthermore, the GAO reported that many of the potential safety issues had not yet been uploaded to the FDA’s drug archival tracking system. In interviews, the FDA told the Government Accountability Office that, “it had prioritized identifying, assessing and addressing potential safety issues over administrative tracking,” due to the extensive workload of its review staff.
The Department of Health and Human Services says that the FDA is currently conducting evaluations in order to improve its computerized tracking system for reviewing drugs. The GAO recommends a complete overhaul of the FDA’s database, so that information can be tracked more efficiently and accurately.
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