Office of Chief Counsel

Mission

The Office of Chief Counsel is composed of litigators and counselors. Litigators handle both civil and criminal cases, participating in case development; drafting pleadings, motions and briefs; and conducting discovery and trials. Counselors provide legal opinions to the major programs of the agency -- drugs, foods, biologics, devices, veterinary products, and enforcement. They participate in rulemaking proceedings, legislative matters, policy deliberations, and international negotiations. In addition, FDA attorneys are involved in explaining agency programs to Congress, regulated industry, and the public.

The Office consists of about 80 lawyers and 20 support staff. It is located at FDA headquarters in Rockville, Maryland, a suburb of Washington, D.C. The Office is a component of the Office of the General Counsel (OGC) of the Department of Health and Human Services. The Office works closely with other components of OGC and with other federal agencies including the Department of Justice on court litigation, the Federal Trade Commission on advertising issues, the Department of Agriculture on food products, the Environmental Protection Agency on environmental and pesticide issues, the Federal Bureau of Investigation on criminal matters, the Department of State on international matters, the Customs Service on imported products, the Postal Service on mail fraud, and the Drug Enforcement Administration on controlled substances.

Major Functions

1. Representing FDA in court proceedings and administrative hearings with respect to programs administered by FDA.
2. Providing legal advice and policy guidance for programs administered by FDA.
3. Acting as liaison to the Department of Justice and other Federal agencies for programs administered by FDA.
4. Drafting or reviewing all proposed and final regulations and Federal Register notices prepared by FDA.
5. Performing legal research and gives legal opinions on regulatory issues, actions, and petitions submitted to FDA.
6. Reviewing proposed legislation affecting FDA that originates in HHS or on which Congress requests the views of the Department.
7. Providing legal advice and assistance to the Office of the Secretary on matters within the expertise of the Chief Counsel