FDA to end alternative summary reporting

The FDA is putting an end to a program that allowed medical device companies to keep the public in the dark about reports of harm and malfunction. The program, called alternative summary reporting, was established in 1997 and its data has not been publicly available.

The agency plans to make past data received through summary reporting publicly available in the coming weeks. The announcement comes a month after a Kaiser Health News investigation uncovered the program collected 1.1 million reports since 2016.

The change also comes as the medical device industry has recently come under fire after a Netflix documentary that debuted in mid-2018 slammed Bayer for its controversial birth control implant, Essure, which has been tied to thousands of injuries.

In particular, makers of breast implants have been able to report adverse events and keep the malfunctions and injuries opaque.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, DM, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

However, the FDA noted the reports it receives can’t be used to determine the frequency of adverse events and that the reports are from an outside party.

The agency began ending its summary alternative reporting program in mid-2017, according to Kaiser Health News, but still accepted hundreds of thousands of injury reports


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