Reviewers: ‘longstanding corruption’ at the FDA

Echoing earlier complaints by drug reviewers, now medical device reviewers at the FDA have begun complaining to Capitol Hill and the Obama administration about allegedly improper management pressures on their work, and the targeted managers have retaliated by opening a criminal investigation against the dissidents.

In a heavily documented letter to the Obama transition team and the New York Times in January, nine unnamed physicians and scientists cited what they termed “independent facts” to allege “longstanding pandemic corruption” in the Center “that cries out for new leadership at FDA from the bottom up.”

The independent facts they cited came from an unnamed federal judge’s decision and findings of fact last year in an Equal Employment Opportunity Commission case that found supervisors in the FDA Center for Devices and Radiological Health, including Office of Device Evaluation director Donna Bea Tillman, “knew or should have known of the hostile work environment” that had resulted from managers’ efforts to force unscientific approvals.

Tillman, a 2005 appointee of CDRH director Daniel Schultz, “Shockingly…herself testified in court that she was aware of the ‘hostile work environment’ but ‘did not want to get involved,’” the dissidents said in their letter to Obama. The dissidents also complained that after conducting an investigation into their issues last year, Schultz concluded that they needed to “move forward” without him taking any curative or disciplinary action.