Report: FDA hiding millions of adverse event reports from docs, public

The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News. Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the report. The summary reporting repository was originally created as an alternative for issues “well-known and well-documented with the FDA” and covers approximately 100 medical devices, according to the Kaiser Health News report.  The FDA declined to provide a complete list of the approximately 100 devices that have been granted reporting exemptions. More than 480,000 injuries or malfunctions were reported in 2017 through the publicly inaccessible pathway, according to the report, with over 2 million events reported through it since 2014. While the reports are still hidden, a new push for transparency at the agency has allowed public individuals to submit Freedom of Information Act requests to obtain information about the incidents – but the wait can take up to two years, Kaiser Health News reports. FDA spokesperson Alison Hunt said that the program “has allowed the FDA to more efficiently review adverse events … and take action where warranted without sacrificing the quality of our review or the inform...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news