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Shapiro, Lewis, Appleton & Favaloro, P.C.
| Shapiro, Appleton & Washburn

The FDA has recently found itself in the middle of a controversy that raises some questions about the extent to which its own scientists and researchers are allowed to challenge drug and medical device approvals. At issue is an allegation that the FDA was using electronic surveillance software to spy on a group of scientists who accused the FDA with “not following the law, not following the science, not following the F.D.A. core values.”

According to an article in the Washington Post, lawyers for the FDA authorized the electronic surveillance, which involved monitoring employee’s email accounts when accessed via work computers, taking screen shots of those computers, and alerting about program activity and printing. The FDA contends it was chiefly concerned with its scientists improperly disclosing confidential business information or trade secrets about medical devices.

But those scientists—some of who have been fired—contend that the spying and subsequent firing was because they were acting as whistleblowers, informing Congressional members and oversight committees of harmful practices at the FDA. Of course, the case is not all clear-cut. Some of the scientists involved may have stood to profit from the accusations that they made, as they were parties to a separate lawsuit against the FDA. Others are accused of contributing to a hostile and toxic work environment at the FDA.

It remains to be seen how this controversy will be resolved—whether the doctors have truly been punished for standing up for ethical medical and regulatory processes at the FDA or whether they were motivated by personal gain. But, the news highlights a need for the FDA to ensure going forward that its scientists have a work environment that enables them to stand up to both the agency and medical manufacturers in favor of public health and safety.

About the Editors: The Shapiro, Lewis & Appleton personal injury law firm, whose attorneys work out of offices in Virginia (VA) and North Carolina (NC), edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard, Eastern Shore Injuryboard, and Northeast North Carolina Injuryboard as a pro bono service.

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