FDA formally ends secret alternative reporting of adverse events

The FDA today said it ended a program that allowed medical device makers to report adverse events to the agency without alerting the public, fulfilling a pledge made after the secret database was brought to light earlier this year.

The federal safety watchdog’s Alternative Summary Reporting repository contains at least 1.1 million adverse event reports filed since 2016, but was so obscure that former commissioner Dr. Robert Califf said he’d “never heard anything about it” during his tenure. In March a Kaiser Health News report unmasked the ASR database, prompting a promise from outgoing commissioner Dr. Scott Gottlieb to release all medical device adverse event reports to the public.

The FDA today made good on that promise by posting the ASR database on its website, covering all reports filed in that system from 1999 to the present.

“Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks,” Dr. Jeffrey Shuren, head of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “To formally end the program, we’ve issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes.”

The FDA also said that part of the ASR sunsetting involves a new program called Voluntary Malfunction Summary Reporting.

“The VMSR program enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. This voluntary program allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis, for eligible device types,” Shuren said in the press release. “Importantly, reports of a death or serious injury are not allowed to be submitted via the VMSR Program and the FDA may still require individual malfunction reports – instead of summary reports – for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.”

The agency said it’s also planning to make its Manufacturer and User Facility Device Experience database easier to navigate.

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