Ombudsman Program was created to enhance the operations of the FDA Office of Regulatory Affairs (ORA) by serving as a confidential, neutral resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders including industry, government, and the public.
The ombudsman assists stakeholders in identifying and evaluating options; explaining the appropriate process for resolution; referring concerns, when possible, to the appropriate office or program; and monitoring outcomes. Stakeholders can request ombudsman assistance with issues involving:
- Dispute resolution
- Mediation/facilitated discussions
- Complaints relating to an action or lack of action by ORA
- Requests for supervisory review of a decision
- General regulatory questions or concerns
- Claims of retribution or unfair treatment
Program Standards of Practice
The ORA Ombudsman abides by ethical principles and standards established by the Coalition of Federal Ombudsmen, the U.S. Ombudsman Association, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, and informality.
Interactions with the FDA can sometimes be confusing, daunting, and complicated. You should find interactions with the staff professionals at ORA helpful and the decision made based on sound policy and regulation. Occasionally, miscommunication could occur due to a lack of feedback, disagreement between the two sides of an issue, or maybe one side has information overload. The ombudsman helps mitigate these and other concerns without the external stakeholder fearing adverse administrative or retaliatory consequences (please refer to the FDA Non-Retaliation Policy). The ombudsman advocates for fairness, efficiency, and effectiveness of ORA operations.
ORA Ombudsman Information Sheet - A flyer about the ORA Ombudsman Program suitable for sharing with all ORA stakeholders
Contact ORA Ombudsman
Toll free 844-871-4536