The FDA Ombudsman

The FDA Office of the Ombudsman is the agency's focal point for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices concerning fair and even handed application of FDA policy and procedures. It serves as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level. It works to resolve externally and internally generated problems for which there are no legal or established means of redress by finding approaches that are acceptable to both the affected party and to the agency.

Type of Cases Handled

• Disputes from regulated industry regarding agency product center or District Office actions.
• Disputes about import detentions.
• Complaints from small businesses, including those referred by the U.S. Small Business Administration.
• Inquiries about the agency's handling of consumer complaints.
• Requests for information and assistance from regulated industry.

Additional Functions

• Coordination of Appeals from decisions made by offices within the Office of the Commissioner under 21 CFR 10.75.
• Coordination of certain administrative hearings that fall under 21 CFR Part 16.
• Coordination of Requests for Reinstatement by disqualified clinical investigators.

Staff

Laurie Lenkel, Director
Andrew Moss, Deputy Ombudsman
(vacant) Paralegal Support Specialist

Phone: (301) 796-8530
Fax: (301) 847-8628
E-mail: ombuds@oc.fda.gov