The FDA’s device center unveiled its regulatory science priorities for 2016. They include leveraging clinical experience, a topic touched on in the House 21st Century Cures bill. The FDA is finally making it a priority to leverage “Big Data” for regulatory decision making, stating that clinical databases contain a wealth of scientific and clinical information relevant to the safety, performance and/or quality of medical devices, sources that are “underutilized in regulatory decision making.” How well we know!
In addition to using data from genetics databases, the FDA has finally acknowledged that there is a vast amount of observational data on medical devices that could enhance the quality of regulatory decision making. The FDA is also finally placing a priority on developing better methods to collect high quality patient experience data, and then to incorporate that data into regulatory decision making.
The 21st Century Cures bill passed by the House last July calls on FDA to evaluate the potential use of evidence from real world clinical experience to support new indications for approved drugs or satisfy post-approval study requirements. That’s what we’ve been saying about the USWR! For example, the US Wound Registry has been tracking adverse events with negative pressure – and really, there aren’t many. We tried to publish our experience several years ago. I wish I had saved the reviewers comments from the rejection that I got from the Journal of the American College of Surgeons after I submitted an article retrospectively comparing about 9,000 wound patients who did not get NPWT with about 1,000 who did. The review’s one line comment was, “What a lot of trouble to go to just to look at safety.” I could feel him holding his nose when he typed the word “safety.” They wanted an article about effectiveness and not safety. How ironic that a few years later, the AHRQ published a review on the safety of NPWT and lamented how few articles had been published on that topic. Some days I could just scream.