U.S. Food and Drug Administration (FDA) — a federal regulatory agency of the U.S. Department of Health and Human Services, not a commercial enterprise. It is headquartered at the White Oak Federal Research Center, 10903 New Hampshire Ave., Silver Spring, Maryland. Its institutional lineage runs to the 1862 Bureau of Chemistry; the name "Food and Drug Administration" was adopted in 1930, and its core regulatory authority dates to the 1906 Pure Food and Drugs Act and the 1938 Food, Drug, and Cosmetic Act. It has no public ticker or equity owners and is funded through congressional appropriations and industry user fees. Public sources put staffing at roughly 18,000 employees across headquarters, laboratories, and field/district offices (fda.gov; GSA/NCPC campus planning documents).
Operations. The FDA reviews and approves human drugs and biologics (CDER, CBER), medical devices and radiation-emitting products (CDRH), foods, dietary supplements and cosmetics (CFSAN), animal drugs and feed (CVM), and tobacco products (CTP). Its work includes premarket review of NDAs, BLAs, 510(k)s and PMAs; facility inspections; post-market safety surveillance; maintenance of the Orange Book of approved drugs and listed patents; grants of marketing and orphan-drug exclusivity; and imposition of Risk Evaluation and Mitigation Strategies (REMS).
Litigation posture. The FDA is not a patent plaintiff, not a patent owner enforcing a portfolio, and not a non-practicing entity. Its single tracked appearance is as a defendant (0 plaintiff, 1 defendant) — an Administrative Procedure Act challenge to agency action rather than a patent infringement suit. Such challenges commonly land in the U.S. District Court for the District of Columbia because it is the agency's home venue.
Notable case. Avadel CNS Pharmaceuticals, LLC v. Xavier Becerra et al. (No. 1:22-cv-02159, D.D.C., filed July 21, 2022). Avadel challenged FDA's decision requiring a Paragraph IV patent certification — rather than a patent statement — for its Lumryz (sodium oxybate) 505(b)(2) NDA, tied to a Jazz Pharmaceuticals Orange Book–listed REMS patent (the '963 patent). The court granted summary judgment to the FDA and intervenor Jazz, holding Avadel had adequate alternative relief in parallel Delaware patent litigation. Related context: Jazz separately sued the FDA in D.D.C. (1:23-cv-01819) over the Lumryz approval and orphan-drug exclusivity.