FDA Lawyers Blog is pleased to announce that FLH Partner Brian J. Malkin was quoted in an FDAnews article by David Pittman commenting on the FDA e-mail monitoring suit concerning several FDA whistleblowers in the Center for Devices and Radiological Health.
FDA Email Monitoring Suit May Chill Whistleblowing on Safety Concerns
The FDA's alleged monitoring of the personal emails of employees who voiced product safety concerns to Congress could dissuade other staffers from airing grievances, industry experts tell DID.
Several FDA staffers are suing the agency, claiming it monitored personal email accounts from the government computers of six FDA scientists and doctors. These employees had contacted congressional staff to draft whistleblower complaints about what they believed were unsafe medical devices that gained approval, according to a lawsuit filed last week in Washington, D.C. federal court. The staffers were harassed and eventually fired from their positions in the Center for Devices and Radiological Health, according to the suit.
If the allegations are true, "this is the kind of retaliation that will intimidate other scientists from stepping forward when they are aware of wrongdoing," Joe Newman, spokesman for FDA watchdog Project on Government Oversight, told DID. "One has to wonder why the FDA seems more concerned about punishing whistleblowers than it is about getting to the bottom of their grievances."
The HHS Office of Inspector General found no criminal conduct and said the staffers had a right to communicate with Congress and journalists.
The FDA's alleged actions, if true, would place employees in a difficult situation, experts said. They would either need to leave the agency to voice their concerns or risk seeing complaints go unanswered if speaking through authorized channels.
The FDA wants its official communications to Congress to go through the agency's legislative office, rather than individuals.
Brian Malkin, attorney with Frommer Lawrence & Haug and a former FDA staffer, suggests the agency clarify what communications its employees can have with legislative staff and other outsiders.
And it should establish criteria for what information can and can't be shared with outsiders, Richard Samp, chief counsel at the Washington Legal Foundation, told DID. Whistleblowers are supposed to expose corruption, not simply publicize the decisions they disagree with, he said.
The FDA does not comment on pending legal actions, an agency spokeswoman told DID.
View the lawsuit at www.fdanews.com/ext/files/CDRH_lawsuit.pdf. -- David Pittman