United States v. Article of Drug Bacto-Unidisk - 394 U.S. 784, 89 S. Ct. 1410 (1969)

Rule:

Congress intends that the Federal Food, Drug, and Cosmetic Act's coverage be as broad as its literal language indicates -- and equally clearly, broader than any strict medical definition might otherwise allow. Courts must give effect to congressional intent in view of the well-accepted principle that remedial legislation such as the Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health, and specifically, 21 U.S.C.S. § 357 purpose to ensure that antibiotic products marketed serve the public with "efficacy" and "safety."

Facts:

After certain antibiotic sensitivity discs, used as a screening test for help in determining the proper antibiotic drug to administer to patients, were marketed without complying with premarket clearance regulations promulgated by the Secretary of Health, Education, and Welfare, proceedings were instituted in the United States District Court for the Eastern District of Michigan to condemn such discs on the ground that they were "drugs" which could not be marketed without complying with the Secretary's regulations. The District Court denied the government's request for condemnation of the discs, holding that they were not "drugs" within the meaning of the Federal Food, Drug, and Cosmetic Act, and the Court of Appeals for the Sixth Circuit affirmed. The United States Supreme Court granted certiorari.

Issue:

Did the antibiotic sensitivity discs in question fall within the general definition of “drugs” under 21 U.S.C.S. § 321?

Answer:

Yes.

Conclusion:

The Court held that the term "drug," which was defined in 201(g)(1)(B) of the Act as an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, was to be construed as broadly as its literal language indicated, and that the antibiotic sensitivity discs were "drugs" within the general definition of 21 U.S.C.S. § 321. According to the Court, a patient would derive less benefit and perhaps more harm from a particular antibiotic if, although the drug itself was properly batch-tested, it was not the proper antibiotic to use. Therefore, the Court found that the discs were subject to pre-market clearance regulations promulgated pursuant to 21 U.S.C.S. § 357.