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UNITED STATES v. AN ARTICLE DRUG . . . BACTO-UNIDISK . . . .

decided: April 28, 1969.

UNITED STATES
v.
AN ARTICLE OF DRUG . . . BACTO-UNIDISK . . . .



CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT.

Warren, Black, Douglas, Harlan, Brennan, Stewart, White, Fortas, Marshall

Author: Warren

[ 394 U.S. Page 784]

 MR. CHIEF JUSTICE WARREN delivered the opinion of the court.

At issue here is the scope of the statutory definition of drug contained in the Federal Food, Drug, and Cosmetic Act and the extent of the Secretary of Health, Education, and Welfare's regulatory authority under that definition. The specific item involved in this definitional controversy is a laboratory aid known as an antibiotic sensitivity disc, used as a screening test for help in determining the proper antibiotic drug to administer to patients. If the article is a "drug" within the general definition of § 201 of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U. S. C. § 321 (1964 ed., Supp. II)), then the Secretary can subject it to pre-market clearance regulations

[ 394 U.S. Page 785]

     promulgated pursuant to § 507 of the Act (21 U. S. C. § 357). Section 507 authorizes the Secretary to require batch certification of any antibiotic product which also meets the general drug definition of § 201. If, on the other hand, the article is merely a "device" under the Act, it is subject only to the misbranding and adulteration proscriptions of the Act and does not have to be pre-tested before marketing; and, of course, if the disc does not fall under either definition, the Act itself is totally inapplicable.

When the discs were marketed without complying with the certification regulations of the Secretary, the Government condemned them pursuant to § 334 of the Act (21 U. S. C. § 331) on the assumption that the discs were drugs and thus validly subject to pre-market regulation. In this action following the condemnation, however, the United States District Court for the Eastern District of Michigan held that the discs were not drugs within the meaning of the Act, suggesting that, if anything, they were devices. It therefore ruled that, since pre-market clearance was not required or authorized, the seizure was improper. The Court of Appeals for the Sixth Circuit affirmed on the same reasoning. We reverse.

I.

Some background information about the development of the discs and the controlling legislation is necessary for an understanding of the determinations made by the Secretary and the courts below. Various antibiotics, known more commonly as "wonder drugs" under such familiar names as penicillin, aureomycin, terramycin, tetracycline, and streptomycin, have proved very useful since World War II in treating numerous infectious diseases.*fn1 Produced biologically, however, these drugs

[ 394 U.S. Page 786]

     tend to vary greatly in their quality and potency unless developed, and thereafter tested, under very carefully controlled conditions. Consequently,*fn2 Congress enacted § 507 of the Food, Drug, and Cosmetic Act, directing the Secretary of Health, Education, and Welfare to

[ 394 U.S. Page 787]

     promulgate regulations establishing such standards of identity, potency, quality, and purity as necessary to ensure the "safety" and "efficacy" of those antibiotics. At present, more than 30 antibiotic drugs are listed (21 CFR § 145.3) with accompanying regulations covering more than 700 pages in the Code of Federal Regulations (21 CFR §§ 141.1-148z.4).

With the proliferation of the various types of antibiotics, doctors found a need for a screening test to help choose which antibiotic to use in treating a particular infection. A diffusion test, using antibiotic sensitivity discs like the one in question here, soon became a widely employed screening method.*fn3 In this test, a round paper disc, which has been impregnated with a specific antibiotic, is placed in contact with sample cultures, or isolates, of a patient's virus, grown in a special culture medium (agar) from a specimen of the patient's fluid (blood, spinal fluid, sputum, urine, etc.). In those places impregnated with an antibiotic to which the patient's infection is sensitive, no new isolate will grow, leaving a clear area (an "inhibition zone"); in those places impregnated with a drug to which the infection is resistant, the isolate will grow, leaving no clear area. The disc is used, in conjunction with a patient's specimen, in laboratory work exclusively, and never comes in contact with any part of the patient's body itself.

[ 394 U.S. Page 788]

     The discs had been in general use for some four years when, in 1960, the Secretary of Health, Education, and Welfare determined to regulate them pursuant to § 507. After notice and an opportunity for public participation, the Commissioner of Food and Drugs, under authority delegated by the Secretary, promulgated regulations requiring pre-clearance, batch-testing, and certification of antibiotic sensitivity discs (25 Fed. Reg. 9369). The Commissioner's action, the regulations noted, followed "numerous complaints by the medical profession, hospitals, and laboratory technicians" and a resulting extensive survey of the use of the discs. That study found the discs unreliable in their statements of potency with resulting loss of safety and efficacy, and thus found it "vital for the protection of the public health" to adopt the regulations (25 Fed. Reg. 9370).

This case arose in May 1962 as an in rem seizure proceeding against an interstate shipment of a number of cases of sensitivity discs, manufactured by Difco Laboratories, Inc., under the trade name of "Bacto-Unidisk." In condemning the product pursuant to § 301 et seq. of the Food, Drug, and Cosmetic Act, the United States claimed, inter alia, that the product, as a "drug" within the meaning of the Act, had not been certified nor exempted from certification as required by § 507 (21 U. S. C. § 357) and the regulations thereunder and was therefore misbranded under § 502 (21 U. S. C. § 352).*fn4 The seizure was proper only if the Secretary's

[ 394 U.S. Page 789]

     regulations subjecting the discs to the pre-market clearance requirements were authorized by the Act. Since the scope of the Secretary's pre-market regulatory power over antibiotic drugs under § 507 depends ultimately on the Act's general definition of "drug" in § 201 (g), the validity of the disc regulations allegedly violated turned on the coverage of the drug definition:

"For the purposes of this chapter --

"(g)(1) The term 'drug' means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories." 21 U. S. C. § 321 (1964 ed., Supp. II).

If, on the other hand, the product was a "device," only the misbranding, adulteration, and labeling provisions of §§ 501 and 502 applied, and the Secretary's disc certification regulations were invalidity promulgated. Although a "device" expressly cannot be a "drug" under the last phrase of the drug ...


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