Many in the medical device industry see the FDA approval process as only having gotten more cumbersome and slow. A new report from the Government Accountability Office (GAO) adds more fuel to the fire.
Released recently, the February-dated report gives kudos to the FDA for meeting its 510(k) performance goals but also calls the agency to task because "the elapsed time from submission to final decision has increased substantially in recent years," jumping 61% from an average 100 days to 161 days. Though to regulators' credit, the GAO report notes that the agency was able to review more than 90% of its 510(k) submissions within three months, a major performance goal. But the review does not include approval time frames, and the overall period does include time taken to comply for requests for more data, critics have noted.
For the more rigorous PMA submission process, the GAO knocks the agency for being "inconsistent" in meeting its own performance goals. What's more, review and decision time for PMA approval products varied highly, the GAO said, but generally jumped from 462 days in 2003 to 627 days in 2008, the last year for which it had available data.
To be fair, the FDA continues to address delays by holding hearings and workshops to seek industry input. The agency has also issued or proposed new guidance to help make regulatory processes smoother. GAO notes that the agency is boosting reviewer training and developing an electronic system for reporting adverse events. (We'll see if they actually work.) But in the short-term, this report becomes a political tool, with impeccable timing. As Modern Healthcare notes, the release comes as Congress begins to debate re-authorizing the industry's user-fee agreement with FDA--a deal that helps fund the review process. Both sides tentatively signed off on a $595 million agreement in early February, but Congress must approve the measure before the old one expires Sept. 30. And reports such as this are already putting the FDA under a microscope.
Case in point: "The GAO oversight report released today confirms a disturbing trend: the FDA is taking longer and longer to make final decisions on life-saving medical devices," Republican Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) said in a written statement, as quoted by The Hill's Healthwatch blog.
- access the GAO report
- read Modern Healthcare's take
- check out The Hill's account