If William Shakespeare was an FDA beat reporter, this is about the time he’d pull out his once more unto the breach bit as we dive back into the controversy regarding whether the agency is slowing the medical device approval process.
A new bi-partisan report from GAO praises the FDA for trying to fix this, then basically notes they haven’t actually fixed it. After reading the report, we could forgive Commissioner Margaret Hamburg if she felt beleaguered liked Shakespeare’s Henry V.
We’ve written about this back and forth he said/she said battle for many moons now and it boils down to this: The medical device industry says FDA is too cumbersome and slow and that it is thwarting innovation. FDA says it is doing better than it gets credit for and slams some device industry studies backing its position as flawed and misleading.
Well, both sides will have some additional ammo from this new GAO report, but overall I think it does more to bolster the medical device industry contention that reviews have gotten slower. GAO doesn’t blast anyone, and it takes great pains to put its findings into useful context. That’s something FDA and the medical device industry don’t always do so well.
“Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years,” GAO notes. Despite making some progress in its approach, FDA’s bottom-line results are not so hot: “Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days.”
GAO also takes FDA to task for being “inconsistent” in meeting performance goals for PMA submissions. “While FDA met the performance goals for original PMA submission for four out of seven years the goals were in place, it met those goals for expedited PMA submissions only twice out of seven years.” Again, the bottom-line results aren’t a report card you’d want to bring home to Mom: “The average time to final decision for original PMAs increased from 462 days for GY 2003 to 627 days for FY 2008,” which is the most recent year for which data is available. Trends in 2009 and beyond don’t appear to be getting any better.
GAO sounded out industry trade and consumer groups and took away four big complaints:
- Insufficient communication between FDA and stakeholders throughout the review process.
- Lack of predictability and consistency in reviews.
- Increased time to reach final decision.
- Inadequate assurance of the safety and effectiveness of approved or cleared devices.
“FDA is taking steps that may address many of these issues,” GAO adds hopefully.
I wonder what Shakespeare would make of all this. Henry V died on the battlefield fighting his version of the good fight. No one is asking for that level of sacrifice from the FDA. But the agency should heed this GAO report and take a cool, hard look at how it reviews medical devices. Public safety is the top goal, of course, but sometimes that means encouraging innovation, too.