FDA Digs Up 600,000 Hidden Adverse Event Reports

On Friday, June 21, 2019, Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), made good on former FDA Commissioner Scott Gottlieb, M.D.’s promise to release more than 20 years of non-public reports of adverse events involving medical devices.

The agency thus ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. The FDA is now making over 600,000 reports received under ASR exemptions from 1999 to 2019 available in the data files linked here.

The files contain ASR data by reporting year, comprising over six million records in total over the last 20-plus years. Each file is large and contains all ASRs received for that year. These are compressed data files using the zip format. After files are downloaded, they should be unzipped.

The FDA makes medical device reports available to the public on the FDA’s public MAUDE database. However, the agency said there were certain cases where reports were not included in MAUDE. Older reports received through CDRH’s legacy Device Experience Network (DEN) reporting system from 1984 – 1996 and reports received under the Alternative Summary Reporting Program from 1999 – April 2019 were not available in MAUDE. Those reports are now available.

In a written statement, Shuren said the FDA also has informed 13 manufacturers that they’ve lost ASR exemptions for devices.

He added that the agency has been working on sunsetting the ASR program since 2017 as it developed the recently unveiled Voluntary Malfunction Summary Reporting Program. That program allows device makers to report events in a quarterly summary that’s made publicly available through MAUDE.

Kaiser Health Network Exposé

As we reported in April, “Gottlieb Promises to Open Hidden Device Database,” this all came to light after the Kaiser Health Network (KHN) began filing Freedom of Information Act (FOIA) requests for the “alternative summary reporting” database and for other special “exemption” reports. But the agency denied a request for expedited delivery of those records, saying the lack of “compelling need” for the public to have the information. Officials noted that it might take up to two years to get such records through the FOIA process.

KHN then went public on March 8, 2019 with a report titled, “Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices.”

Three weeks later, then-Commissioner Gottlieb wrote:

“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.”

The agency has now made good on that promise.