US FDA Industry "Retaliation" Plan

16 July 1995

The US Food and Drug Adminstration is to draw up a document describing the agency's processes for retaliation and dispute resolution, and outline the industry's rights in this area. The document is to be developed by the FDA's Office of Chief Mediator and Ombudsman, in order to enhance the industry's knowledge and use of the Office, according to FDA Commissioner David Kessler.

Dr Kessler's statement comes in response to a request by members of the Senate Labor and Human Resources Committee for him to outline what affirmative steps the FDA proposes to adopt "to reassure those regulated by the agency that they may feel completely comfortable exercising their right to speak freely to the Congress, without threat of retribution or retaliation from the agency." According to the Senators, some industry spokesman had been unhappy at the prospect of testifying before the Committee on agency issues because of the fear of retaliation.

In his response, Dr Kessler also said that following a meeting with senior agency officials, additional steps have been identified which will "increase employees' sensitivity to the issue and enhance the agency's ability to deal with any allegation of retaliation." A number of other initiatives are to be explored to deal with this issue, he added.

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