GAO Report Evaluating FDA Performance Released

The U.S. Food and Drug Administration (FDA) has been pelted with criticism recently regarding its medical device testing and approval practices. Consumer Reports (CR) released a report that insinuated the FDA is too lax on the medical device industry and gives devices 510 (k) clearances or pre-market approvals (PMAs) too easily. The U.S. Government Accountability Office (GAO) has released a report evaluating the FDA’s performance goals and has something to say about its device approval practices—and it’s not what one might expect.

Despite CR’s allegation that the FDA clears some devices requiring “nothing more” than some paperwork and a user fee, the GAO finds that the FDA is taking longer between submission and final decision for 510(k) clearances than it has in previous years. As for PMAs, the most recent data available shows that the average time to final submission has increased from 462 days in fiscal year 2003 to 627 days in fiscal year 2008. The increase in review time comes two months after medical device makers agreed to pay twice the amount of user fees it had been paying before in support of the FDA shortening its review time. The user-fee program is up for renewal in September.

While CR has been criticizing the FDA for supposed irresponsible practices, the medical device industry has been questioning the increased review time. The GAO report points out that where the FDA runs into problems is when its review requires more information from the device maker in question, which of course indicates responsible review practices. The FDA pointed out to the GAO that the only alternative to requesting more information (if review time is to be decreased) is to reject the submission outright.

The GAO interviewed unnamed consumer advocacy groups (CR is an advocacy group) as well. According to the report, these groups suggested the FDA should speak to patients as part of its review process. These groups also took issue with the “lack of predictability and consistency in reviews” as well as the increased review time.

In order to address the issues raised, the FDA will be taking steps such as “issuing new guidance documents, enhancing reviewer training, and developing an electronic system for reporting adverse events” according to the report.

The GAO is an independent, non-partisan agency that works for Congress. Its goal is to investigate how the federal government spends taxpayer money.