U.S. Sup. Ct.
12-142
The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers to gain Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce. 21 U. S. C. §355(a). Once a drug is approved, a manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.” 21 CFR §314.70(b)(2)(i). Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label. See §§314.94(a)(8)(iii), 314.150(b)(10).
