Federal investigators are taking another look at complaints by Food & Drug Administration scientists that senior managers at the federal watchdog agency pressured them to approve medical devices, despite the reviewers’ concerns about health risks.
The inspector general’s office of the Dept. of Health and Human Services is re-opening its investigation of the scientists’ complaints, which they made public last year in an open letter to President Barack Obama.
The letter detailed numerous instances in which FDA officials violated agency rules and, in some cases, federal law. It went on to say that “sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”
“Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA,”according to the April 2009 letter. “As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.”
The HHS inspector general’s initial investigation of the charges was closed in March, after it was determined that no criminal wrongdoing occurred. But the scientists called foul, according to the Wall Street Journal, saying that their main allegations never involved criminal matters in the first place. An independent group, the Project on Government Oversight, launched an investigation of its own and took the findings to the HHS inspector general earlier this year.
That prompted the IG’s office to look into the charges again. The office is also digging into the Center for Devices & Radiological Health, taking a look at the already-much–studied 510(k) clearance process and the FDA’s process for resolving internal disputes, HHS deputy inspector general for investigations Gerald Roy told the Journal.
