A senior US Senator has warned acting Food and Drug Administration (FDA) Commissioner Frank Torti that “attempts to silence whistleblowers are illegal,” after a confidential memo which he sent to all agency staff this month was leaked.

In the memo, entitled Protecting Confidential Information, Dr Torti states that while the FDA “is committed to the principles of open government and transparency,” it “must comply with its obligations to keep certain information in its possession confidential.”

Such information generally relates to trade secrets, confidential commercial information (CCI), personal privacy information, privileged intra-agency and inter-agency documents and law enforcement records and information, says Dr Torti’s memo, which goes on to warn staff that violation of the laws governing disclosure or requiring confidentiality “can result in disciplinary sanctions and/or individual criminal liability. Improper disclosure could also result in FDA being sued for damages.”

Senator Charles Grassley, the senior Republican on the powerful Senate Finance Committee, says he believes the memo “goes beyond legitimate privacy concerns and could be viewed “as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws to communicate with Congress.”

In a letter, Sen Grassley also tells Dr Torti he is concerned with the timing of the memo, “given some recent high-profile matters concerning your agency and the release of information that has shown failures in FDA's regulatory mission.”

Attempts to silence whistleblowers are illegal, he reminds Dr Torti, and tells him: “it would have been prudent for you to include a section in your memorandum that outlines the interplay between protected confidential and trade secret information and making protected disclosures to Congress and/or Inspectors General in accordance with the whistleblower protection laws. Absent such a discussion, many FDA employees could take this memo to mean that they could be criminally sanctioned for providing information to Congress.”

In fact, FDA employees have the right to talk to Congress and provide it with information, “free and clear of agency influence” or fear of retaliation or reprisal, says Sen Grassley, and he calls on Dr Torti to issue a second memo to staff outlining their rights and protections, to “set the record straight.”

- In late January, nine FDA scientists told President Barack Obama they believed they were under criminal investigation after they had told Congress that illegal activities were ongoing at the agency.

The scientists had initially told then-FDA Commissioner Andrew von Eschenbach last May of their concerns that staff working on reviews for medical devices were being forced by their managers to manipulate data, thus endangering patient safety. He promised an internal review but by October nothing had happened, and the scientists then asked legislators for an investigation, which they began in November.

Alerting the Obama Administration’s transition team of their concerns at the beginning of the year, the FDA staffers claimed that the agency was “fundamentally broken.” The system had been “corrupted and distorted by current FDA managers,” and there was an atmosphere at the agency “in which the honest employee fears the dishonest employee,” they said.