FDA to Eliminate Program That Hid Faulty Medical Device Reports
The Food and Drug Administration (FDA) announced that it will be eliminating its “alternative summary reporting” program and ending its practice that allows medical device makers to conceal reports of harm and malfunctions from the public.
Past records will be opened to the public within weeks.
The announcement comes months after an investigation by Kaiser Health News found that the program collected more than 1 million reports since 2016. The change also comes as the medical device industry has come under fire after a Netflix documentary criticized Bayer for its birth control implant. The implant, Essure, has been linked to thousands of injuries.
The agency started wrapping up its summary alternative reporting program in 2017, but it was still accepting hundreds of thousands of injury reports. According to the investigation by Kaiser Health News, the FDA accepted more than 190,000 injury reports and 45,000 malfunction reports in the first nine months of 2018.
The FDA previously stated that the program was designed to allow for a more efficient internal review of risks. A spokesman for the FDA, Angela Stark, said the agency will also end the exemptions in place for makers of pacemakers, implantable cardiac defibrillators and tooth implants.
The FDA does note that the reports are from a third party, and that it cannot use the reports to determine the frequency of adverse events. The data release will include reports that were filed before mid-2017.
While the agency will be putting an end to this program, it has not said that it will stop allowing device makers to file other types of device-harm exemption reports that are hidden from the public.
The FDA will replace the program with a newer summary-reporting program that allows more than 5,000 types of medical devices to send spreadsheets that detail device malfunctions. However, device makers will not be able to report serious injuries using this method.