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
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.
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.
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.
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).
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 invalidly promulgated. Although a "device" expressly cannot be a "drug" under the last phrase of the drug definition above, a device is given almost a parallel definition in § 201 (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;
In resolving this question in the negative and holding the seizure invalid, the District Court noted in a memorandum opinion
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)).
Although there was some testimony below debating the precise extent of the public health dangers posed by the sensitivity discs, the courts below declined to substitute their judgment for that of the Commissioner of Food and Drugs by determining whether his action was really necessary to protect the public health from a purely medical viewpoint. Rather, the courts below quite properly confined the inquiry to an examination of whether the disc regulations, even if medically unwise, were authorized by the Act, and more specifically, by the Act's definition of "drug." Despite the renewed effort here to relitigate the public health issue, we agree with the decision implicitly made by the courts below not to base a resolution of this case on the public need for, or medical wisdom of, the Secretary's regulations requiring pre-market clearance of antibiotic sensitivity discs. 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.
We need not stop to parse the language of the Act's definition of drug, for the District Court found, and the parties do not disagree here, that a literal reading of the words "intended for use in the . . . cure, mitigation, [or] treatment" of disease "clearly has application" to
At the outset, it is clear from § 201 that the word "drug" is a term of art for the purposes of the Act, encompassing far more than the strict medical definition of that word. If Congress had intended to limit the statutory definition to the medical one, it could have so stated explicitly, or simply have made reference to the official United States Pharmacopoeia (or the National Formulary), as it did in the first of the three subsections of § 201 (g) (1), and let the definition rest there. The historical expansion of the statute's definition, furthermore, clearly points out Congress' intention of going beyond the medical usage. The 1906 Food and Drug Act, for instance, defined "drug" in a rather limited way to include "all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation,
The enactment of the 1938 Federal Food, Drug, and Cosmetic Act illustrates the expansion of the definition of drug. One of the changes contemplated in S. 2800, an early version of the Act,
Senator Copeland of New York, who sponsored the Act, remarked about the inclusion of the word "devices" in his prepared statement introducing S. 2800 as follows:
The definition was revised in S. 5, 74th Cong., 1st Sess. (1935), to include substances, preparations, and devices intended for diagnostic purposes, as well as for cure, mitigation, treatment, or prevention of disease (S. 5, § 201 (b), S. Rep. No. 361, 74th Cong., 1st Sess. (1935)).
In answer to Senator Clark's remark that a bathroom scale would be classified as a drug, Senator Copeland made the following comment:
Despite Senator Copeland's proffered explanation, there was continued criticism during the Senate debates (79 Cong. Rec. 4905-4920, 5215-5234)
As a result of the criticism on the Senate floor, Senator Copeland proposed an amendment to add a definition of "device" to parallel that of drug, an amendment which was included
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, 693-695 (1948); United States v. Dotterweich, 320 U.S. 277, 283-284 (1943).
Respondent's alternative contention, that even if its product does fall within the purview of the Act, it is plainly a "device" and therefore by definition necessarily
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, 124-125 (1953)).
Furthermore, the legislative history, read in light of the statute's remedial purpose, directs us to read the classification "drug" broadly, and to confine the device exception as nearly as is possible to the types of items
In upholding the Secretary's construction of the Act, we are not unmindful of our warning that "[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." 62 Cases of Jam v. United States, 340 U.S. 593,
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)
"(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 (l) 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."
"A drug or device shall be deemed to be misbranded—
"(l) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, 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."
Most of the Act's legislative history is reprinted in C. Dunn, Federal Food, Drug, and Cosmetic Act (1938).
"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."