FDA

Created byRegulatory function created by Pure Food and Drugs Act of 1906 (Bureau of Chemistry); named FDA in 1930; modern charter is the Federal Food, Drug, and Cosmetic Act of 1938 (ch. 675, 52 Stat. 1040); agency itself first codified in statute by the Food and Drug Administration Act of 1988 (P.L. 100-607, Title V)

Head appointed21 U.S.C. § 393(d)(1): Commissioner of Food and Drugs appointed by the President by and with the advice and consent of the Senate; no fixed term (PAS)

Removal standardno statutory protection — at will (serves at the pleasure of the President; reports to the HHS Secretary per 21 U.S.C. § 393(d)(1))

Funded underHybrid: annual Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, plus industry user fees — e.g., prescription-drug fees (PDUFA, 21 U.S.C. § 379h), device fees (21 U.S.C. § 379j), generic-drug fees (21 U.S.C. § 379j-42), and tobacco assessments that fully fund the tobacco program (21 U.S.C. § 387s)

Congressional oversightHouse Energy and Commerce · Senate Health, Education, Labor, and Pensions

Inspector generalHHS OIG (PAS establishment IG under the Inspector General Act, now codified at 5 U.S.C. ch. 4)

Judicial reviewMostly APA § 702 suits in district court; specific direct court-of-appeals review for some orders (e.g., drug-approval withdrawals, 21 U.S.C. § 355(h); tobacco marketing denials, 21 U.S.C. § 387l(a))