Grassley Asks Torti to Confirm Whistleblower Protection

April 2, 2009
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Senator Charles Grassley (R-IA) sent a letter to Frank Torti, acting commissioner of the US Food and Drug Administration, to express concern about a memo that Torti sent to agency staff.

On Mar. 24, 2009, Senator Charles Grassley (R-IA) sent a letter to Frank Torti, then the acting commissioner of the US Food and Drug Administration, to express concern about a memo that Torti had sent to agency staff. (Joshua Sharfstein took over as acting commissioner on Mar. 30, 2009.) Torti’s memo emphasized employees’ responsibility to maintain the confidentiality of certain information and warned that violations would result in disciplinary actions and criminal liability. In his letter, Grassley asserted that Torti’s memo was stricter than legitimate privacy concerns warrant and appeared to contradict laws that protect members of the executive branch who communicate with Congress.

“Federal laws protect whistleblowers and allow people who work in the federal bureaucracy to discuss what’s happening inside an agency with other officials. Attempts to silence whistleblowers are illegal,” Grassley said in a press release. “If the memo sent last week was intended to have a chilling effect on FDA employees who want to speak up about problems, then that memo is contrary to the president’s call for open and transparent government, and the acting commissioner needs to set the record straight.”

Recent high-profile allegations that lobbying influenced FDA’s decisions prompted Grassley’s concern about the memo. In his letter, Grassley cited a Wall Street Journal story about allegations that the agency gave special treatment to ReGen Biologics (Hackensack, NJ) when it examined the company’s Menaflex device for knee injuries. Grassley also referred to an IndyStar article about Eli Lilly’s (Indianapolis, IN) role in removing a skeptical physician from an advisory panel that was considering the company’s Effient blood thinner.

Grassley drew Torti’s attention to specific sections of laws that sanction officials who discourage or prevent federal employees from communicating with Congress. Grassley also cited statutory penalties for officials who demote, fire, or threaten to punish employees because of their interactions with Congress. In his letter, Grassley asked Torti to review these statutes and reevaluate the memo to agency workers. “I believe that you should take the further step of issuing a second memorandum to FDA employees outlining their rights and whistleblower protections, as well as outlining the FDA’s responsibilities for respecting those protected disclosures,” said Grassley in the letter.

Grassley coauthored the Whistleblower Protection Act of 1989 and has cosponsored legislation to update the law. In February 2009, Grassley urged President Obama to honor federal whistleblowers in a Rose Garden ceremony as a way to encourage “speaking the truth,” according to the press release.