Looks like outgoing FDA Commissioner Scott Gottlieb, M.D. wants to leave behind a giant data dump.
A recent Kaiser Health News (KHN) investigation revealed a hidden FDA reporting pathway used by device makers to report allegedly millions of injuries and malfunctions for about 100 medical devices. Gottlieb is promising to release those reports.
In a March 27, 2019 tweet, 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.”
Exemption From MAUDE
Agency data reportedly shows that more than two million alternative summary reports have been filed since the start of 2014.
The reporting pathway allowed device makers to seek an “exemption” from the MAUD (Manufacturer and User Facility Device Experience) reporting system. Devices with such exemptions included surgical staplers. Gottlieb reportedly said he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.”
The FDA has declined to provide a complete list of the devices that have been granted reporting exemptions over the years but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.
In mid-2017, the FDA began requiring a public report summarizing data filed within the FDA. “But nearly two decades of data remained cordoned off from doctors, patients and device-safety researchers,” reported KHN. An FDA official told KHN that the program was for issues that were “well-known and well-documented with the FDA.”
Last September, KHN began filing Freedom of Information Act (FOIA) requests for the “alternative summary reporting” database and for other special “exemption” reports. “To little effect,” reported KHN. A request to expedite delivery of those records was denied, and the FDA cited 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.
S. Lori Brown, M.D., a former FDA official who accessed the data for her research, told KHN, “The public has a right to know about this.” She said doctors relying just on the public reports, “can easily reach the wrong conclusion about the safety record of a particular device.”
We’ll keep you updated of any reports that surface related to orthopedic devices.
