Dive Brief:
- The results of a new report by the Office of Special Counsel, which examines allegations within the federal government, conclude insider complaints against the FDA were unsubstantiated.
- The issue, which was first raised in late 2008, surrounded the FDA's approvals for breast-cancer and colon-cancer screening devices.
- The counsel reported the FDA did alter certain internal practices after the complaint was lodged, primarily surrounding how it handles internal disputes over medical product approvals.
Dive Insight:
The handling of the whistleblower complaints garnered as much interest as the complaints themselves, due to revelations in 2012 the FDA was monitoring the computer activity of employees that had alleged safety issues with certain colonoscopy and breast-cancer devices.
The news raised controversy at the time over whether the whistleblowers' rights were being infringed upon, but the involved congressional committees at the time elected to not pursue the FDA employees' safety complaints.
The new special counsel report determined the previous investigations by the FDA and HHS, which found no wrongdoing, “appear to be reasonable," The Wall Street Journal reports.
Additional high-profile healthcare whistleblower cases have also emerged recently. According to Becker's Hospital Review, 504 hospitals across the U.S. operated under Healogics have been hit with a lawsuit over false claims allegations, and Fort Lauderdale, Fla.-based Broward Health paid $69.5 million to settle a federal kickback case alleging the system violated the False Claims Act by engaging in "improper financial relationships" with physicians.