DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville MD 20857
June 29, 1995
TO: All FDA Employees
FROM: Commissioner of Food and Drugs
SUBJECT: Allegations of Retaliation
I want to address a very important issue--allegations of retaliation--that implicates core agency values.
As FDA employees, our mission is to protect, promote, and enhance the public health. We also have important responsibilities to the industries we regulate, including working to bring new products to the market and minimizing regulatory burdens.
In carrying out this mission, FDA employees are required to make many decisions and take many actions involving complex clinical, scientific, legal, and factual issues. In this context, questions can be, and have been, raised about the fairness of agency proceedings and retaliatory actions-against companies which challenge or criticize the agency. In recent Congressional hearings, for example, some companies testified that they were victims of regulatory harassment or felt they were at a competitive disadvantage because they were on an uneven "playing field." Other companies declined to testify in Congressional hearings because of concerns about possible FDA retaliation.
We must take such concerns and allegations very seriously. Without question, companies are free to vigorously challenge agency positions and requirements, and to freely voice their views to the agency, the press, the public, and the Congress. One of our fundamental duties as FDA employees is to be scrupulously fair, even-handed and objective. We can accept no less. Fear of retaliation among those we regulate may chill scientific, legal and policy discourse, depriving the agency of information crucial to sound judgments and decisions. Given our special responsibilities, all FDA employees must make every effort to avoid even the appearance of unfairness or retaliatory action.
Because of the critical importance of these issues, any allegation of retaliation should be reported immediately to Amanda B. Pedersen, FDA's Chief Mediator and Ombudsman, HF-7, Parklawn, Room 14-105, (301) 443-1306. In addition, anyone with concerns about retaliation or related issues should contact, or be referred to, that office. Ms. Pedersen and her staff will treat matters in confidence, and will work with other agency offices to address all relevant issues.
The Interim Deputy Commissioner for Operations, the Associate Commissioner for Regulatory Affairs, and the Center Directors will be undertaking further initiatives in their respective organizations to ensure both fairness and the appearance of fairness. Because of the complexity of the issues presented and the potential for agency decisions to affect members of the regulated communities and other interested persons, this is a challenging, but vitally important task.
As an agency, we are making many changes and seeing positive results that you have helped bring to fruition. We must enhance our vigilance to ensure the fairness and objectivity of our actions. We must work with dedication and creativity to foster open and candid discourse and to reduce the perceptions of unfairness and fears of retaliatory action.
David A. Kessler
Date created: October 17, 1996; last update: July 7, 2005
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