Why is the FDA Hiding Millions of Adverse Events from Doctors & The Public?

Kaiser Health News reports the FDA is hiding millions of adverse events from medical professionals and the public. Why would this be the case? The FDA was set up long ago to protect the public. According to the report, at least 1.1 million adverse event reports have been moved into the FDA’s “alternative summary reporting” system—inaccessible to the public and according to some reports completely hidden to most clinical research stakeholders. Apparently, this summary reporting system was designed for well-known and well-documented issues and purportedly includes 100 medical devices according to the Kaiser Health News report.  The FDA declined to provide a full list of the approximately 100 devices granted reporting exemptions. Other key data points:

480,000 + injuries or malfunctions were reported in 2017 through the public but inaccessible system
2+ million events have been reported since 2014

A confluence of movements has converged to drive a push for greater transparency: and the FDA is feeling the pressure. Kaiser Health News reports that the transparency movement materializes with many Freedom of Information Act requests to obtain incident information—however waits ...