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FDA Achieves Small Win as Whistleblower Law Passed


The FDA won a small victory in a legal dispute with the National Whistleblower Center over the agency's right to withhold documents relating to its medical device review process.

This article published with permission from The Burrill Report.

The U.S. Food and Drug Administration (FDA) won a small victory in a legal dispute with the National Whistleblower Center just ahead of Congress passing legislation to strengthen protections for federal employees who uncover waste, fraud and abuse in government operations.

The Whistleblower Center took the agency to district court over documents the FDA withheld or redacted when responding to a Freedom of Information Act (FOIA) request the center made on behalf of FDA scientists who expressed concern in 2010 over the agency’s medical device review process.

The Whistleblower Center argued that the documents were held back to protect confidential commercial or financial information. Instead, argued the Department of Health and Human Services’ Office of General Counsel, the withholding and redactions were made under two FOIA exemptions: one protecting inter-agency or intra-agency records that would not be available by law to a party in litigation with the agency; and the second from providing files that would constitute an unwarranted invasion of personal privacy if disclosed.

The New York Times reported July 15 that the FDA monitored thousands of emails disgruntled agency scientists sent to reporters, Congress members and others. The newspaper says that the effort began as a narrow investigation into five scientists in mid-2010, but quickly expanded “to counter outside critics of the agency’s medical review process.”

The FDA acknowledges the surveillance of the scientists, saying its intent was to make sure information wasn’t being shared inappropriately.

The decision in U.S. District Court for the District of Columbia came just ahead of bipartisan passage of The Whistleblower Protection and Enhancement Act, legislation strengthening protections for federal whistleblowers.

Among the improvements included in the law are new protections for whistleblowers, provisions holding agencies accountable for retaliatory investigations against whistleblowers, and giving the Office of General Counsel greater authority to shape whistleblower law by allowing this office to file friend of the court briefs in important cases.

President Barack Obama is expected to sign the bill soon.

Copyright 2012 Burrill & Company. For more life sciences news and information, visit www.burrillreport.com.

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