Federal investigators cleared Food & Drug Administration managers of criminal acts against agency scientists who opposed clearances given to some medical devices, according to the Wall Street Journal.
Anonymous scientists at the federal watchdog agency wrote open letters last year to Congress and President Barack Obama, citing "serious wrongdoing" by top FDA officials and asking Obama to clear house in the Center for Devices and Radiological Health.
“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 letter to Obama. “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.”
But a federal probe into the allegations found no cause for criminal proceedings, according to the newspaper. The U.S. Dept. of Health and Human Services’ inspector general won’t be making any criminal referrals to the Justice Dept., FDA chief counsel Ralph Tyler told the Journal. The agency hired a management consulting firm to investigate workplace issues and allegations not addressed by the HHS inspector general, FDA spokeswoman Meghan Scott told the paper.
CDRH director Jeffrey Shuren, who came on board after the imbroglio broke into public view, said the agency takes the dissidents’ complaints seriously.
"We do have a zero tolerance policy for retaliation," Shuren said, according to the newspaper.
Tyler said the FDA won’t release the report to the FDA scientists or the public. A longtime device reviewer said the chief counsel asked several members of the whistleblower coalition to meet with the management consulting firm, aiming to get the device division back on the rails.
One whistleblower told the Journal he welcomes the outside review.
"At least management has recognized that some of the violations of regulations we raised may not be criminal, but are nonetheless serious, and hurt the workings of the division," the dissident said.