FDA Whistleblower Case Moving Ahead

Jane Akre
November 14, 2012
November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration.

Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were victims of surreptitious surveillance and a violation of their rights to privacy.

MDND Background story is here and here.

Judge James Boasberg found about 1,500 documents, which the NWC had sought from the FDA, were properly withheld or redacted because they did not contain information on “government impropriety.”

The NWC had been fighting to obtain the documents, but the FDA argued they might contain trade secrets of the companies they monitor.

The Freedom of Information Act (FOIA) allows documents to be withheld when they contain company trade secrets, any attorney-client privileged information, and personal information that could be considered a violation of privacy. These types of documents can be withheld, but only if there is no evidence of government wrongdoing.

Boasberg wrote the documents “Do not approach the level of misconduct contemplated by these cases with respect to either improper approval of medical devices or retaliation against FDA employees.”

The employees, who were in the medical devices division, wrote to Rep. John Dingell in an October 14, 2008 letter (these are excerpts) :

“The U.S. Food and Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA's mission to protect and promote the health of all Americans.

“Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).

“There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices.

“Managers at CDRH with no scientific or medical ex~_ devices, or any clinical experience in the practice of medicine.__,have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements. To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.

“At the same time, there is a need for new legislation that modernizes the regulatory structure of the 510(k) program so that complex medical devices are not allowed onto the market without a comprehensive (or in some cases, any) clinical evaluation of their safety and effectiveness.”

Meanwhile the case, now in its 14th month continues. NWC had obtained thousands of documents related to the case and the Department of Justice, on behalf of the FDA, has filed a motion to dismiss the case which will be heard in December.

The case is filed as Hardy et al v. Shuren et al here.

Here is the letter October 14, 2008 by 11 whistleblowers to Rep. John Dingell concerning mismanagement at the FDA’s CDRH. It's a pretty interesting read.

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