FDA Law refers to the laws and regulations governing the research, development, manufacturing, promotion, sale, and distribution of foods, drugs, medical devices, cosmetics, and animal drugs. The term “drug” includes both prescription and nonprescription drugs, as well as biotechnology products and vaccines. “Foods” can include traditional foods, as well as medical foods and dietary supplements.
A number of statutes make up the regulatory scheme for these products in the United States, including most notably the Federal Food, Drug, and Cosmetic Act. There are also the Public Health Service Act, the Fair Packaging and Labeling Act, the Controlled Substances Act, the Poison Prevention Packaging Act, the Lanham Act, and numerous other federal, state, and local laws. Broader principles of administrative law and other laws governing administrative agencies such as the Freedom of Information Act also come into play. These laws are implemented and enforced by a range of regulatory authorities, including the United States Food and Drug Administration, the Drug Enforcement Administration, the Consumer Product Safety Commission, the United States Department of Agriculture, the Federal Trade Commission, and state agencies.
FDA Law practitioners apply their knowledge of the governing laws and agency practice to provide strategic advice to clients. For example, a lawyer in this field might guide clients on the best strategy for obtaining approval of a new drug or medical device, help a client respond to an adverse FDA inspection, review proposed marketing campaigns, or conduct internal investigations of quality or marketing practices. FDA Law practitioners also represent clients in enforcement proceedings, participate in legislative and agency rulemaking proceedings, and support corporate deals and other transactions. For example, an FDA Law practitioner might conduct regulatory due diligence for an acquisition or draft regulatory provisions of agreements or securities filings. FDA Law practitioners also represent clients in litigation involving underlying regulatory issues.
In selecting a lawyer for an FDA Law matter, clients should carefully consider the lawyer’s substantive expertise, along with his or her knowledge of the applicable regulators, and legal and practical judgment. The field is complex and at times arcane. There is no substitute for counsel with deep subject matter expertise and real world experience.