FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request

By | July 5, 2019

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 “is now posted online.”

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 “compelling need” 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 “alternative summary reporting” 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: “I 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.”

KHN had asked the FDA to expedite processing in April, citing a March 27 tweet by FDA Commissioner Scott Gottlieb, which stated, “It’s imperative that all safety information be available to the public. We’re now prioritizing making ALL of this data available.”

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A FOIA officer responded a few days later to say KHN’s appeal fell under “unusual circumstances” and that the FOIA “office will need to consult with another office or agency that has substantial interest in the determination of the appeal.”

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:

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