There’s a new chapter in the ongoing saga of the medical device adverse event reports. In the latest entry, outgoing FDA Commissioner Scott Gottlieb tweeted on Wednesday that all of the adverse event reports would be made open to the public.
Here's Gottlieb's tweet:
This is an old database where historical information wasn't easily accessible electronically owing to the system's age. But it's imperative that all safety information be available to the public. We're now prioritizing making ALL of this data available. https://t.co/T1c3qQQQ3E
— Scott Gottlieb, M.D. (@SGottliebFDA) March 27, 2019
To recap, the agency came under fire earlier this month when Kaiser Health News reported that at least 1.1 million incidents had been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE.
In an interview with MD+DI earlier this month, an FDA spokesperson said the agency issued a guidance document about the program in October 2000 that is still publicly available and solicited public comments on the document required by law.
FDA modified the conditions of ASR exemptions in 2017 to include the submission of Form 3500A, which summarizes the reports submitted for that quarter and is available in the MAUDE database.
The agency noted that each MDR summary report is posted on MAUDE and clearly identifies the number of adverse events associated with the summary report, so patients or others in the public will have increased visibility regarding the number of reported adverse events that may be related to the same issue or device.
The agency said the majority of the exemptions were revoked following a review of the program, and that generally only low-risk products are eligible for voluntary malfunction summary reporting.
Gottlieb’s pledge to make the adverse events public comes shortly before his exit from FDA next month. He is stepping down nearly two years after he was appointed to the top position of the regulatory agency.
MD+DI reported that Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner until a permanent replacement is found.