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For Immediate Release
February 2, 2012

Grassley Seeks FDA Answers on Targeting of Agency Whistleblowers on Medical Devices

WASHINGTON – Sen. Chuck Grassley has asked the Food and Drug Administration to account for its treatment of a group of agency scientists who questioned approvals of medical devices in communications with Congress and the White House.  The FDA appears to have punished the employees for expressing safety concerns about radiological devices used to detect diseases such as breast cancer and colon cancer.

“The FDA has a poor track record of retaliating against whistleblowers.  This situation appears to be more of the same,” Grassley said.  “Federal law explicitly protects the right of federal employees to provide information to Congress.  I reminded the FDA of the relevant law in January 2009 after this came to my attention.  Still, even after that letter, the FDA appears to have persisted in a long campaign to punish a group of employees for talking to Congress.   I’m pursuing this matter with the FDA to get answers and ensure that whistleblowers aren’t singled out and retaliated against for protected disclosures to Congress.”

Grassley wrote to FDA Commissioner Margaret A. Hamburg, asking for a description of whether each of the staff members involved still works at the agency and if not, for an explanation of the circumstances of the employee’s departure.  Grassley also sought details of who authorized the monitoring of the employees’ e-mail and to what extent such monitoring occurred.  The agency engaged in extensive monitoring of the employees’ email accounts, apparently to try to justify its case for retaliation.

Grassley also reminded Hamburg that any retaliation against whistleblowers “directly contradicts” her promise during her 2009 confirmation hearing that she would protect whistleblowers by “creating a culture that enables all voices to be heard.”

“The FDA has a huge responsibility to protect public health and safety,” Grassley said.  “With all the important work that needs to be done on that front, it’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress.”

Grassley also sought answers from Hamburg on what the agency is doing in light of the retaliation inquiry to reassure employees of their right to provide information to Congress.

“Without federal whistleblowers, I wouldn’t be able to perform my constitutional oversight of the executive branch,” Grassley said.  “Whistleblowers come forward to shed light on matters that affect public safety or the public purse.  They expose incompetence and malfeasance and promote reform that leads to better government.  Their perspective has done a lot of good.  I’ve seen this kind of behavior from the FDA before, and it’s troubling to think there might be a pattern.  The FDA needs to make an immediate effort to reassure employees of their freedom to talk to Congress.  Muzzling is inappropriate and illegal.  Retaliation of this kind is intolerable by any federal government agency.”

Grassley, a long-time advocate for whistleblowers, works to strengthen whistleblower protections for all government employees.  Certain employees, including members of the Public Health Service Commissioned Corps within the Department of Health and Human Services, are not covered under the Whistleblower Protection Act, which leaves employees vulnerable to retaliation.  This is a loophole in current law that needs to be closed.  Grassley is actively working to ensure that employees of the commissioned corps are given necessary whistleblower protections.

Grassley’s letter to the FDA is available here.  His 2009 letter to the FDA is available here.  Washington Post articles on the matter are available here and here.