https://www.fda.gov/ombudsman 1 

FDA’s Office of the Ombudsman

Assisting in resolving disputes between companies or individuals and FDA offices.

Who We Are, What We Do

An ombudsman is someone who looks into and 

addresses complaints and disputes involving an 

organization. But the role of the ombudsman here 

at the Food and Drug Administration (FDA) involves 

much more. 

FDA’s ombudsman function is handled at

two levels:

• a separate office within the Office of the 

Commissioner (FDA Office of the Ombudsman)

• designated ombudsmen within specific product 

centers (drugs, devices, biologics, tobacco) and 

office of regulatory affairs

Companies can turn to the FDA Office of the 

Ombudsman for:

• dispute resolution

• mediation

• breaking up “log jams” with the agency

• guidance and assistance in solving problems with 

the agency or with FDA-regulated products 

• general regulatory questions or concerns

Cases We Handle

The following types of cases are routinely handled by 

the FDA Office of the Ombudsman:

• Disputes from regulated industry regarding agency 

product center actions, or lack of action, and those 

issues that cut across center jurisdictions

• Disputes from regulated industry related to 

interactions with agency field offices, including 

inspection and compliance issues

• Concerns from small businesses, including those 

referred by the U.S. Small Business Administration

• Inquiries about the agency’s handling of Freedom of 
https://www.fda.gov/ombudsman 2 

Information Act (FOIA) requests

• Requests for information and assistance from 

regulated industry regarding agency policy and 

regulations, and on how to work with the agency

How We Handle Disputes

The various methods used by the FDA Office of 

the Ombudsman for handling disputes include 

consultation, dispute resolution, and mediation.

Typical actions include: 

• Determining relevant issues and obtaining complete 

and accurate information about a case

• Reviewing and acting on cases in a timely manner

• Initiating meetings with affected parties

• Recommending more transparent reasons for 

agency action/decision, when warranted

• Recommending alternative courses of action

Confidentiality:

• May be requested with regard to identity and nature 

of complaints

• Will be honored, but may restrict complaint/dispute 

resolution actions

FDA has a strict non-retaliation policy that protects 

anyone who files a complaint against the agency.

Other Functions

The FDA Office of the Ombudsman has responsibility 

for the following additional functions:

Liaison to the Small Business Administration

• Serves as FDA liaison to the National Ombudsman’s 

Office at the Small Business Administration (SBA)

• Handles issues that fall under the Small Business 

Regulatory Enforcement Fairness Act (SBREFA)

• Responds to all complaints referred to FDA under 

SBREFA, involving any agency regulatory area

Coordination of:

• Certain appeals made under 21 CFR 10.75

• Complaints received under the Information

Quality Act

• Certain administrative hearings that fall under 21 

CFR Part 16

FDA’s Office of the Ombudsman

CONTACT

FDA OFFICE OF THE OMBUDSMAN

Laurie Lenkel, R.Ph., J.D., Director

Talisha Williams, B.S., MCPM, Assistant Ombudsman

FDA Office of the Ombudsman

10903 New Hampshire Avenue 

WO 1, Room 4204

Silver Spring, MD 20993

Phone: (301) 796-8530

Fax: (301) 595-8041

E-mail: ombuds@oc.fda.gov

www.fda.gov/ombudsman

FDA PRODUCT CENTER OMBUDSMEN

Drugs

Phone: (301) 796-3436

E-mail: cderombudsman@fda.hhs.gov

Devices

Phone: (301) 796-0293

E-mail: cdrhombudsman@fda.hhs.gov

Biologics

Phone: (240) 402-7912

E-mail: cberombudsman@fda.hhs.gov

Office of Regulatory Affairs

Phone: (844)-871-4536

oraombudsman@fda.hhs.gov

Tobacco

Phone: (301) 796-3095

E-mail: ctpombudsman@fda.hhs.gov

General FDA Information

Phone Toll-Free: 888-INFO-FDA (888-463-6332)

www.fda.gov

U.S. Department of Health and Human Services

U.S. Food and Drug Administration

FDA Office of the Ombudsman

Office of Scientific Integrity

Office of the Chief Scientist

Office of the Commissioner