Facing a growing backlash over secret adverse event reports on medical devices, the outgoing commissioner of the U.S. Food and Drug Administration (FDA) pledged this week to start working to make hundreds of thousands of previously undisclosed reports freely available to the public for the first time.
FDA says secret files on medical device problems will be opened to public
Agency chief disclosed the intention a week before his expected departure.
March 29, 2019 at 2:57AM
FDA Commissioner Dr. Scott Gottlieb, who is expected to step down on April 5, said on Twitter on Wednesday that the agency is "now prioritizing making ALL of this data available."
Gottlieb's social media comment came in response to a Kaiser Health News report published earlier that day by NBC News that said the FDA had quietly allowed more than 2 million reports of problems related to medical devices to slip into hidden files called "alternative summary reports" since the start of 2014. Doctors use injury-report data to inform decisions about which devices to use.
Previously, the contents of those summary reports were only available through the Freedom of Information Act (FOIA) requests, which can take years to receive and be subject to arbitrary redactions of key information.
FDA spokeswoman Deborah Kotz said Thursday via e-mail that the agency is working to make summary reports prior to 2017 available without an FOIA request. The agency has greatly whittled down the number of reporting "exemptions" that allow summary reports to be filed in the place of full reports on each incident.
"A total of 108 exemptions had filed been since the inception of the Alternative Summary Reporting program in 1997," Kotz wrote. "Only 3 exemptions are still active today, with plans to fully phase out the program this year. In most cases, the FDA revoked exemptions due to changing circumstances. … In a small number of instances, the FDA revoked exemptions due to the voluntary withdrawal from the program by manufacturers or where the conditions of the exemption were no longer met."
Redacted reports
In the past, the FDA routinely redacted information in public filings that could tip off the public to the existence of summary reports, such as the summary's approval number, which could be used to FOIA the data and understand how many other summaries exist, since the report numbers are sequential.
For example, on Feb. 24, 2014, the FDA allowed Minnesota-run Medtronic PLC to summarize an undisclosed number of adverse events pertaining to its controversial Infuse Bone Graft biotech product for lower-back surgery. Information on those adverse events was collected as part of a study more than five years earlier and was summarized in a "marker" report whose exemption-approval number was redacted. Medtronic has said the reports were withheld mistakenly but that the information in them would not have added to public knowledge about Infuse.
Following questions from the Star Tribune in 2015 and 2016, the FDA acknowledged that the summary report should have disclosed that the number of adverse events contained in the summary was 1,039. At the time they were collected, that was triple the number of public reports about Infuse on file with the FDA.
Since then, Kaiser Health News (KHN) and the International Consortium of Investigative Journalists have each published reports exposing how other controversial device injury reports have been concealed from the public using summary reporting. Those hidden reports included hundreds of thousands of reported problems with breast implants — problems that were the subject of a major FDA hearing earlier this week.
One KHN report highlighted hidden adverse-event reports regarding surgical staplers, of which Medtronic is a major seller. Following the KHN report, the FDA sent out a letter to health care providers announcing that an FDA review of its own files had turned up 41,000 past medical device reports on surgical staplers, including 9,000 serious injuries and 366 deaths.
"The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler," the FDA letter said.
That statement was unusual. Typically the FDA and medical-device makers take pains to note that the FDA's public adverse-event report system, known by the acronym MAUDE, cannot be used to tell whether a device caused the underlying adverse event.
Adverse events
"Adverse event" is an umbrella term used to describe situations where something went wrong, regardless of the cause.
Federal law requires medical device companies to file MAUDE reports when the company learns that an adverse event has caused or contributed to death or serious injury, or when manufacturers become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if it reoccurred.
Since 1997, the FDA has also established summary-reporting programs that allow the device companies to get exemptions from the normal reporting requirements, which was the effect of allowing them instead to file the reports without public scrutiny. Sometimes the "marker reports" for summaries make explicit reference to spreadsheets of adverse events that are not filed in MAUDE.
In response to critical news accounts of this summary reporting system, FDA Commissioner Gottlieb said on Twitter on Wednesday, "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."
Kotz, the FDA spokesperson, said that in an effort to promote greater transparency to the public, the agency changed the conditions of the alternative summary reporting (ASR) program so that the filing of marker reports is mandatory. These public-facing reports in MAUDE summarize all of the adverse events submitted over a prior quarter, including identifying the number of events in each report.
"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," Kotz' e-mail said. "In addition, after review of the ASR program, the majority of the exemptions have been revoked."
In most cases, she wrote, the FDA revoked exemptions because of changing circumstances, like implementation of electronic medical device reporting and participation in voluntary summary malfunction reporting.
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Pioneering surgeon has run afoul of Fairview Health Services, though, which suspended his hospital privileges amid an investigation of his patient care.
