In what is being called a victory for patients and consumers, the U.S. Food and Drug Administration (FDA) said that it is ending its controversial “alternative summary reporting” program, which allowed medical device manufacturers to conceal reports of harm and malfunctions from the general public.
FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD, announced the decision in a statement on increasing transparency about the safety of breast implants.
The alternative summary reporting was established in 1997 “to more efficiently review adverse events for well-established risks but was not allowed for patient deaths and unusual, unique, or uncommon adverse events,” they explained. The program was obscure; the general public, forensic medical device experts, “and even a recent FDA commissioner were unaware of its existence,” according to a Kaiser Health News investigation.
An FDA spokesperson told Kaiser Health News that this is a culmination of efforts to improve transparency that began in mid-2017, when the agency began revoking reporting exemptions for saline breast implants and intra-aortic balloon pumps. It also is ending alternative summary reporting exemptions for manufacturers of implantable cardiac defibrillators, pacemakers, and tooth implants.
Going forward, medical device manufacturers will be required to file individual reports, describing each case of patient harm related to a medical device, in the FDA’s public device-harm database known as Manufacturer and User Facility Device Experience, or MAUDE.
Source: Kaiser Health News, May 3, 2019.