Source: https://supreme.justia.com/cases/federal/us/394/784/
Timestamp: 2019-04-19 05:09:02+00:00

Document:
Antibiotic sensitivity disc used as laboratory screening test to help determine proper antibiotic drug to administer to patients held not merely a "device" but a "drug" within definition of § 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, and thus subject to pre-market clearance regulations issued pursuant to § 507 of the Act. Pp. 394 U. S. 791-801.
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.
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. [Footnote 3] 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.
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).
"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."
parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals."
21 U.S.C. § 321(h). Finally, it was established at trial that of the various definitions given above, the operative ones in this case were § 201(g)(1)(B) of the drug provision and § 201(h)(1) of the parallel device definition; [Footnote 5] the essential question underlying the validity of the regulations, then, was whether the Bacto-Unidisks were "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."
"evidence affords no basis for the conclusion that the definition of 'drug' in the Federal Food, Drug, and Cosmetic Act . . . was intended by Congress to extend beyond the meaning of that term in medical science, to encompass these sensitivity disks."
suggested, without deciding, that the discs would be more appropriately classified as "devices" under the Act.
On appeal, the Court of Appeals for the Sixth Circuit affirmed, accepting the District Court's conclusions that the Bacto-Unidisk was not a "drug" in the medical sense of the term and that Congress did not intend the statutory definition of "drug" to be any broader than the medical one. 392 F.2d 21, 23. The court noted that the discs did aid physicians in the determination of what antibiotic to use for the cure, mitigation, or treatment of disease by furnishing useful information, but held that Congress did not intend to apply the statutory phrase "intended for use in the . . . cure, mitigation, [or] treatment" in such an indirect manner. 392 F.2d 21, 22. We granted the Government's petition for certiorari because this interpretation of the Act raised issues of importance in the administration of the Federal Food, Drug, and Cosmetic Act (393 U.S. 911 (1968)).
is enough for us that the expert agency charged with the enforcement of remedial legislation has determined that such regulation is desirable for the public health, for we are hardly qualified to second-guess the Secretary's medical judgment. Our sole concern is whether the statute's definition of "drug" authorizes the disc regulations contested here, and, while we agree with the lower courts' limited conception of the issue, for reasons outlined below, we reverse their disposition of it.
Respondent's primary contention here is that the sensitivity discs are not subject to any of the provisions of the Act, because Congress did not intend it to cover articles used so indirectly in the "cure, mitigation, [and] treatment" of disease. Respondent uses the same two-step analysis relied on by the courts below: (1) Congress did not intend to write the drug definition more broadly than does the medical profession, and (2) the medical concept of drug is limited to articles that are administered to man either internally or externally. Alternatively, respondent argues, even if the Act's "intended for use" language does cover the discs, they must clearly be classified as devices. In view of the legislative history discussed below and the broad, remedial purpose of the Act itself, however, we hesitate to give the critical language such a narrow, restrictive reading in the absence of congressional direction to do so, and we therefore reject the contention that the discs do not properly fall within the purview of the Act. For the same basic reasons, we furthermore reject the argument that the discs, once found to come under the Act's coverage, must be classified specifically as devices, and not drugs.
the Bacto-Unidisk. Although respondent again urges that the disc itself does not "treat" a patient in the same way an antibiotic does in terms of personal application, the disc plays at least some role in the selection of the appropriate drug. Thus, the essential question for our determination is whether Congress intended the definition of drug to have the broad coverage the courts below and the parties agree its words allow. Viewing the structure, the legislative history, and the remedial nature of the Act, we think it plain that Congress intended to define "drug" far more broadly than does the medical profession. The reason for including a separate, almost parallel, definition of "devices" in the Act is, as the legislative history shows, relevant to congressional intent. It is therefore helpful to consider both the question of the Act's initial application and the question of the drug-device dichotomy at the same time.
or prevention of disease of either man or other animals."
34 Stat. 768, 769. As subsequent congressional action clearly indicates, however, the cope of that original definition has since been greatly enlarged.
"(1) all substances and preparations recognized in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United States, or National Formulary or supplements thereto, and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals, and (3) all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body."
preparations which are intended to alter the structure or some function of the body, as, for example, preparations intended to reduce excessive weight. There are many worthless and some dangerous devices and preparations falling within these classifications. S. 2800 contains ample authority to control them."
"[I]f the devices ought to be outlawed, they ought to be outlawed, and I have no objection to that; but to maintain that a purely mechanical device is a drug and to be treated as a drug in law and in logic and in lexicography is a palpable absurdity, in my opinion."
"Mr. President, I desire to state the effect of this amendment. There are on the market certain electrical devices. A man takes hold of the handles of the machine, and the indicator spins around.
It stops at 'appendicitis,' or it stops at 'meningitis.' . . . Such a device is manifestly a fraud upon society. That is what the amendment is designed to deal with."
Id. at 4842. Despite Senator Copeland's proffered explanation, there was continued criticism during the Senate debates (79 Cong.Rec. 4905 4020, 5215-5234) [Footnote 10] of the definition on the ground that it would lead to the incongruous result of calling the following items "drugs": shoulder braces (id. at 4841), radium belts (ibid.), electrical devices (id. at 4842), bathroom weight scales (ibid.), and hospital air conditioning apparatus (id. at 5231). [Footnote 11] The opposition finally settled on "crutches" (id. at 4913) [Footnote 12] to signify the ultimate absurdity of the drug definition's broad coverage.
"For the first time, it is proposed in a bill before Congress to control therapeutic devices. . . . There are hundreds of worthless contrivances being sold to and used by gullible people. Suffice it to say that a fake contraption for the cure of consumption is just as serious a menace to health as is a worthless drug sold for the same disease."
tragedy in the fall of 1937. [Footnote 17] (S. 3073, 75th Cong., 2d Sess.) The excepting clause of § 201(g)(1), stating clearly that a drug cannot be a device, was also added in 1938 (S. 5, 75th Cong., 3d Sess., H.R.Rep. No. 2139).
The historical expansion of the definition of drug, and the creation of a parallel concept of devices, clearly show, we think, that Congress fully intended that the Act's coverage be as broad as its literal language indicates -- and, equally clearly, broader than any strict medical definition might otherwise allow. Strong indications from legislative history that Congress intended the broad coverage the District Court thought "ridiculous" should satisfy us that the lower courts erred in refusing to apply the Act's language as written. But we are all the more convinced that we must give effect to congressional intent in view of the well accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health, and specifically, § 507's purpose to ensure that antibiotic products marketed serve the public with "efficacy" and "safety." Cf. United States v. Sullivan, 332 U. S. 689, 332 U. S. 693-695 (1948); United States v. Dotterweich, 320 U. S. 277, 320 U. S. 283-284 (1943).
not a "drug," must also be rejected, we believe, in light of the foregoing analysis. At the outset, it must be conceded that the language of the statute is of little assistance in determining precisely what differentiates a "drug" from a "device": to the extent that both are intended for use in the treatment, mitigation and cure of disease, the former is an "article" and the latter includes "instruments," "apparatus," and "contrivances." Despite the obvious areas of overlap in definition, we are not entirely without guidance in determining the propriety of the Secretary's decision below, given the overall goals of the Act and its legislative history.
More specifically, as we have previously held in an analogous situation where the statute's language seemed insufficiently precise, the "natural way" to draw the line "is in light of the statutory purpose" (SEC v. Ralston Purina Co., 346 U. S. 119, 346 U. S. 124-125 (1953)). [Footnote 18] Since the patient will tend to derive less benefit and perhaps some harm from a particular antibiotic if, though the drug itself was properly batch-tested, it was not the proper antibiotic to use, it was entirely reasonable for the Secretary to determine that the discs, like the antibiotics they serve, are drugs, and similarly subject to pre-clearance certification under § 507. An opposite conclusion might undercut the value of testing the antibiotics themselves, for such testing would be a useless exercise if the wrong drug were ultimately administered, even partially as the result of an unreliable disc.
"[i]n our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop."
U.S. 593, 340 U. S. 600 (1951). Our holding here simply involves an obvious corollary to that principle, that we must take care not to narrow the coverage of a statute short of the point where Congress indicated it should extend.
MR. JUSTICE DOUGLAS, being of the view that an antibiotic sensitivity disc used by physicians to aid them in determining what antibiotic drug, if any, to give to a patient, is a "device" as defined in § 201(h) * of the Act, not a "drug" as defined in § 201(g) would affirm the judgment.
* "The term "device" . . . means instruments, apparatus, and contrivances . . . for use in the diagnosis . . . of disease in man. . . ." It would indeed be difficult to write a clearer description of an antibiotic sensitivity disc.
See generally L. Goodman A. Gilman, The Pharmacological Basis of Therapeutics (3d ed., 1965).
"(a) The Secretary of Health, Education, and Welfare, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. For purposes of this section and of section 352(1) of this title, the term 'antibiotic drug' means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance)."
"(b) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure, and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this section."
See generally Bauer, Kirby, Sherris, & Turck, Antibiotic Susceptibility Testing by a Standardized Single Disk Method, 45 American Journal of Clinical Pathology 493 (1966); Petersdorf Sherris, Methods and Significance of In Vitro Testing of Bacterial Sensitivity to Drugs, 39 American Journal of Medicine 766 (1965); Gould, The Laboratory Control of Antibiotic Therapy, 3 Chemotherapia 477 (1961); Second Report of the Expert Committee on Antibiotics, Standardization of Methods for Conducting Microbic Sensitivity Tests, World Health Organization Technical Report Series No. 210, pp. 12-17 (1961).
"A drug or device shall be deemed to be misbranded --"
"(1) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracyeline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 357 of this title, and (2) such certificate or release is in effect with respect to such drug: Provided, That this subsection shall not apply to any drug or class of drugs exempted by regulations promulgated under section 357(c) or (d) of this title."
Respondent's witnesses established that sensitivity discs are not listed in the United States Pharmacopoeia or the National Formulary, and thus do not come within that portion of the definition of "drug" in § 201(g)(1)(A).
The District Court's opinion is unreported; its pertinent findings of fact and conclusions of law are quoted in the opinion of the Court of Appeals, 392 F.2d 21, 22-23 (1968).
The earliest versions were S.1944, 73d Cong., 1st Sess. (1933), and S. 2000, 73d Cong., 2d Sess. (1934). S. 2800 was succeeded by S. 5, 74th Cong., 1st Sess. (1935). S. 5 died in the House, but was succeeded by S. 5, 75th Cong., 1st Sess. (1937), and was the bill eventually enacted into law, as supplemented by S. 3073, 75th Cong., 2d Sess. (1937), and H,R. 9341, 75th Cong., 3d Sess. (1938).
Most of the Act's legislative history is reprinted in C. Dunn, Federal Food, Drug, and Cosmetic Act (1938).
See Dunn, supra. n 7, at 214, 237, 239.
Id. at 429 (remarks of Senator Clark).
"I do not think the President of the United States would tolerate for a moment a piece of legislation that described crutches as 'drugs' and advertising as 'adulteration,' carrying the English language and the law very far."
"A definition of devices is provided paralleling that of drugs. This expansion of the definition of the term 'drug' and the inclusion of devices are essential if the consumer is to be protected against a multiplicity of abuses not subject to the present law."
(S.Rep. No. 646, 74th Cong., 1st Sess. (1935).) See Dunn, supra, n 7, at 477.
This was the "Elixir-Sulfanilamide" tragedy of September-October, 1937, where nearly 100 persons died as the result of consuming an untested drug. See Report of the Secretary of Agriculture on Deaths Due to Elixir Sulfanilamide-Massengill (submitted in response to S.Res.194 of November 16, 1937), in Dunn, supra, n 7, at 1316-1327.
Cf. Cawley v. United States, 272 F.2d 443, 445 (C.A.2d Cir.1959): "[U]nless they explicitly forbid it, the purpose of a statutory provision is the best test of the meaning of the words chosen."
Cf. AMP Inc. v. Gardner, 389 F.2d 825, 830 (C.A.2d Cir.), cert. denied sub nom., AMP Inc. v. Cohen, 393 U.S. 825 (1968), petition for rehearing pending.
"Any chemical compound or any non-infectious biological substance, not used for its mechanical properties, which may be administered to or used on or for patients, either human or animal, as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiological or pathological condition."

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