Non-Retaliation Policy

At the FDA, 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.

We 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 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 the Office of the Ombudsman. In addition, anyone with concerns about retaliation or related issues should contact that office. Such matters will be treated in confidence, and the office will work with other agency offices to address all relevant issues.