The Office of the Chief Counsel (OCC), which is the Food and Drug Division of the HHS Office of the General Counsel, is composed of litigators, counselors, and support staff. Litigators handle both civil and criminal enforcement cases, and defend challenges to provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), the implementing regulations, and FDA policies, initiatives, and decisions. The litigators work closely with agency compliance personnel to ensure an adequate evidentiary foundation for enforcement matters, prepare referrals to the Department of Justice, draft memoranda setting out the agency's interpretation of the law, develop case strategy, conduct negotiations, prepare and respond to discovery, and are key participants in hearings, trials, and appellate proceedings. The litigators act as the liaison to the Department of Justice during active litigation, and in many criminal prosecutions have been asked to work as Special Assistant United States Attorneys, assuming primary responsibility for prosecuting violations of the FDCA or related statutes. The litigators frequently work closely with senior officials at the Department of Justice and play an active role in all of FDA's cases, including matters before the United States District Courts, the Courts of Appeal, and the United States Supreme Court.
The counselors provide legal services to FDA and HHS officials on matters involving FDA-regulated products, such as drugs, biologics, food, medical devices, cosmetics, veterinary products, radiation-emitting products, and tobacco products. Such services include, for example, review and revision of draft and final regulations, draft and final guidance documents, responses to citizen petitions, draft legislation, press materials, and correspondence. In addition, the counselors advise agency officials on complex medical product approvals and safety issues and food safety and nutrition issues. During emergencies, such as foodborne illness outbreaks, novel influenza epidemics, or potential bioterrorism attacks, the counselors provide legal services essential to the government’s effective immediate response.
In addition, the counselors have active roles in agency activities related to Congress. For example, the counselors review agency officials’ written congressional testimony and congressional correspondence, analyze pending FDA-related legislation, and help FDA respond to congressional requests for technical assistance or other briefings. The counselors help FDA implement new, as well as longstanding, legislation, which often involves complex legal analyses of intricate statutory provisions. The counselors also participate in FDA’s interactions with other federal agencies (e.g., USDA, EPA, FTC) and with state public health agencies. The counselors also advise FDA officials on their interactions with stakeholders, such as members of the public, health care providers and institutions, regulated firms, and associations representing a broad range of interest groups. The counselors also contribute significantly to the transparency of the agency’s actions through interpretation and implementation of the Freedom of Information Act, the Federal Advisory Committee Act, the Administrative Procedure Act, and other administrative law activities.
The OCC litigators and counselors also have central roles in FDA’s administrative proceedings, such as clinical investigator disqualification hearings, hearings on product approval withdrawals, and civil money penalty hearings. The litigators and counselors also advise agency enforcement officials on pending compliance issues and review certain warning letters sent to firms and individuals believed to have violated the FDCA or related laws. Support staff assist with all OCC activities through applying their technical skills.
Through all of these activities, OCC advances FDA’s mission of promoting and protecting the public health.