Regulatory Focus™ > News Articles > Senator Grassley Expresses 'Concern' About FDA Treatment of Whistleblowers, Opens Investigation

Senator Grassley Expresses 'Concern' About FDA Treatment of Whistleblowers, Opens Investigation

Posted 02 February 2012 | By Alexander Gaffney, RAC 

Senator Charles Grassley, a Ranking Member on the Senate Committee on the Judiciary has called for an investigation of the US Food and Drug Administration's (FDA) actions relating to their treatment of nine whistleblowers. The staff scientists and physicians had brought up concerns about actions within the Center for Devices and Radiological Health (CDRH) to both the Congress and the White House in 2009, and have reportedly suffered reprisals from agency staff as a result of their actions.

The Washington Post reported last week that six of the whistleblowers have filed a lawsuit against the agency in the US District Court in Washington, charging the agency with violating their privacy rights by monitoring their interactions with Congressional staffers and other lawful activities.

Concerns raised by the whistleblowers include that CDRH was approving, or about to approve, devices that were not proven to be safe or effective. All of the staff scientists involved in writing the letter have since been let go by the agency, fired, passed over for promotion or harassed, according to statements obtained by The Washington Post.

In a public letter released on 31 January, Grassley called on FDA to release information regarding the authorization of monitoring activities, the current status of the whistleblowers within the agency, the scope and depth of monitoring activities, employee access to Congress and confidentiality procedures. Grassley further demanded access to all intercepted emails, records and communications related to the whistleblowers.

In addition, Grassley specifically called on the agency to release all records of emails intercepted between whistleblowers and his office.

In a statement released last week, Grassley said that "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 serves on both the Senate Finance Committee, which has jurisdiction over the funding of most agencies.

Grassley said he is troubled by FDA's actions. "It is troubling to me to see your Agency actively pursue the dismissal of an employee against the advice of the OSC-not because they violated procedure and leaked genuinely confidential classified information, but simply because you 'cannot trust him,'" wrote Grassley in his letter to Commissioner Hamburg.

In the absence of evidence to the contrary, and in light of two opinions from oversight agencies that the employees had not violated any rules or laws, the employees should not have been subject to any retributive actions, wrote Grassley.

Grassley had particularly harsh words for FDA Commissioner Margaret Hamburg. Grassley claimed FDA's actions had directly contradicted her confirmation hearing testimony, in which she claimed that she wanted to "create a culture that enables all voices to be heard."

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