Outgoing FDA Commissioner Dr. Scott Gottlieb said in a tweet yesterday that the agency plans to release all medical device adverse event reports to the public.
The move comes only weeks after a Kaiser Health News investigation revealed that millions of adverse event reports have been hidden from the public through the agency’s “alternative summary reporting” repository.
“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,” Gottlieb wrote in a tweet.
Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the KHN report.
Gottlieb is slated to exit his position at the head of the federal watchdog next Friday leaving current National Cancer Institute head Dr. Normal Sharpless, who was tapped earlier this month to serve as acting Commissioner once Gottlieb exits, to handle the release of the previously hidden reports.
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