Many of the documents are related to FDA monitoring of emails sent by FDA scientists who began complaining several years ago about how new medical devices were being evaluated by the FDA’s medical device center. The New York Times recently reported on the wide-ranging surveillance operation the FDA underwent to capture those emails the scientists privately sent out to members of Congress, lawyers, labor officials, journalists and President Obama. The scientists have filed lawsuits against the FDA.
Meanwhile, Fulton, Md.-based Quality Associates was hired to print materials to make available to parties in the litigation. Those confidential files were available online for several days earlier this year, but have since been removed. It’s unclear how the files were made public.
The FDA claims it wasn’t interfering with the scientists’ right to complain about safety issues to Congress, but rather that it sought to discern how confidential information was being disclosed, according to the Wall Street Journal report.
More Articles Related to the FDA:
Will the New FDA Law Really Curb Drug Shortages?: 6 Things to Know
FDA May Release Mobile Medical App Guidelines
FDA Issues Class 1 Recall for GE Ventilator
