The Food and Drug Administration responded Wednesday to a Freedom of Information Act request filed months ago, noting that the information sought by Kaiser Health News 鈥渋s now posted online.鈥
KHN had filed a series of FOIA requests, beginning in September 2018, seeking hidden reports of malfunctions or injuries tied to scores of medical devices. The FDA said fulfilling the requests would take up to 22 months and denied a KHN request for expediting the process because there was no 鈥渃ompelling need鈥 to release the information.
In the meantime, KHN published a series of stories that showed more than a million reports had been filed to the hidden database, bypassing the public database known as MAUDE that doctors, researchers and patients rely on to spot problems with devices. Reports of malfunctioning surgical staplers, leaky breast implants and inaccurate blood glucose tests instead were sent to the agency as 鈥渁lternative summary reporting鈥 files.
In the wake of those news stories, the FDA announced it would shut down the alternative summary reporting program and release the data in the hidden reports, which it published online on June 21. In an emailed statement Wednesday morning, an FDA official said: 鈥淚 believe this satisfies your FOIA request and the denial of expedited processing appeal, let me know if there are remaining issues to address, otherwise we will close your request and appeal.鈥
KHN had asked the FDA to expedite processing in April, citing a March 27 tweet by FDA Commissioner Scott Gottlieb, which stated, 鈥淚t鈥檚 imperative that all safety information be available to the public. We鈥檙e now prioritizing making ALL of this data available.鈥
A FOIA officer responded a few days later to say KHN鈥檚 appeal fell under 鈥渦nusual circumstances鈥 and that the FOIA 鈥渙ffice will need to consult with another office or agency that has substantial interest in the determination of the appeal.鈥
That was the last KHN heard from the FOIA office about this request until this week.
The hidden database released June 21 included 5.7 million incidents of malfunctions and injuries linked to medical devices over two decades. KHN analyzed this data and published five findings last week.
Read the original investigation:
