Abbott Laboratories v. Gardner

Mr. Justice Harlan delivered the opinion of the Court.

In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, as amended by the Drug Amendments of 1962, 76 Stat. 780, 21 U. S. C. § 301 et seq.), to require manufacturers of prescription drugs to print the “established name” of the drug “prominently [*138] and in type at least half as large as that used thereon for any proprietary name or designation for such drug,” on labels and other printed material, § 502 (e)(1)(B), 21 U. S. C. § 352 (e)(1)(B). The “established name” is one designated by the Secretary of Health, Education, and Welfare pursuant to § 502(e)(2) of the Act, 21 U. S. C. § 352 (e) (2); the “proprietary name” is usually a trade name under which a particular drug is marketed. The underlying purpose of the 1962 amendment was to bring to the attention of doctors and patients the fact that many of the drugs sold under familiar trade names are actually identical to drugs sold under their “established” or less familiar trade names at significantly lower prices. The Commissioner of Food and Drugs, exercising authority delegated to him by the Secretary, 22 Fed. Reg. 1051, 25 Fed. Reg. 8625, published proposed regulations designed to implement the statute, 28 Fed. Reg. 1448. After inviting and considering comments submitted by interested parties the Commissioner promulgated the following regulation for the “efficient enforcement” of the Act, § 701 (a), 21 U. S. C. § 371 (a):

“If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation, shall accompany each appearance of such proprietary name or designation.” 21 CFR §1.104 (g)(1).