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Project on Government Oversight




Investigation into Wrongdoing at FDA Re-Opened: But Will It Be Different This Time?

September 28, 2010 


The Associated Press reports that the Department of Health and Human Services (DHHS) has re-opened an investigation into allegations of egregious wrongdoing at the FDA’s Center for Devices and Radiological Health (CDRH), the FDA center responsible for approval of medical devices.

But will the investigation fully address the many serious violations of FDA regulations alleged by whistleblowers within the agency? And will it address whistleblower claims—claims that POGO believes to be valid—of retaliation?

An initial investigation, completed in 2009, effectively ignored the whistleblower complaints that prompted the investigation.

In a letter sent today HHS Deputy Inspector General Gerry Roy—the newly appointed head of the DHHS Office of Investigations—POGO reviewed the deep flaws of the initial investigation, which was conducted by Roy's predecessor, and expressed concern that failing to conduct a more thorough investigation would have serious consequences:

We remain gravely concerned that current FDA leadership is hiding behind the seemingly favorable outcome of the 2009 investigation and is using this outcome as an excuse for not taking the necessary corrective actions. The result: tragic injuries and deaths caused by defective medical devices. The approval by FDA of these defective devices was and continues to be enabled by the wrongdoing never addressed by the 2009 investigation.

The letter also details four case studies in which the FDA approved—or is on its way to approving—a device for marketing despite strong recommendations against doing so by expert physicians and scientists in the FDA. In some instances, whistleblowers said they were retaliated against after they called the agency's attention to the undue risk created by a device and urged the FDA to reject the manufacturer's request that the device be approved for marketing.

For over two years, FDA whistleblowers have alleged that serious wrongdoing at the agency, including repeated violations of FDA regulations, has compromised the safety of medical devices.

Find more details about this issue in POGO's letter to Gerry Roy.

Founded in 1981, the Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO's investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government.

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