UNITED STATES v. BACTO-UNIDISK

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 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.1 Produced biologically, however, these drugs tend to vary greatly in their quality and potency unless developed, and thereafter tested, under very carefully controlled conditions. Consequently,2 Congress enacted § 507 of the Food, Drug, and Cosmetic Act, directing the Secretary of Health, Education, and Welfare to 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.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).

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).4 The seizure was proper only if the Secretary's 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:

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;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."

In resolving this question in the negative and holding the seizure invalid, the District Court noted in a memorandum opinion6 that the concept of drug is limited in a medical sense to articles administered to man either externally or internally, and ruled that the "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." The District Court pointed out that although a "literal reading" of § 201 (g) (1) (B) "clearly has application to the article libeled herein," enforcing such an application would be "ridiculous and contrary to common sense." The court therefore held that the Bacto-Unidisk did not fall within the purview of the Act for the reason that it was not medically a drug, and 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)).

II.

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 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.

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 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.

III.

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, or prevention of disease of either man or other animals." 34 Stat. 768, 769. As subsequent congressional action clearly indicates, however, the scope of that original definition has since been greatly enlarged.

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,7 defined "drug" to include

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)).8 As the inclusion of the word "diagnosis" came before the Senate for consideration, a controversy developed on the floor, aimed more at the word "devices," which was not then before the Senate, than at the word "diagnosis." 79 Cong. Rec. 4841-4845 (1935).9 Senator Clark contended that it was not proper to classify devices as drugs, and that diagnostic devices were so broadly defined as to make even a bathroom scale a drug:

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)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).11 The opposition finally settled on "crutches" (id., at 4913)12 to signify the ultimate absurdity of the drug definition's broad coverage.

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 included13 when the bill was returned to the Senate Committee on Commerce and later agreed to by the Senate without debate. (Id., at 8351-8355.14) The ultimate effect of the various amendments, of course, was still to include devices under the control of the Act for the first time, the goal Senator Copeland had originally set out to achieve. As Congressman Chapman of Kentucky explained to the House after the bill had passed the Senate, "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." 80 Cong. Rec. 10236 (1936).15 According to the Chief of the Food and Drug Administration, the reason for providing a separate definition of devices, instead of using Senator Copeland's original drug definition, was simply to avoid "the incongruity of classifying certain devices, such as the electric belt, therapeutic lamps, and so forth, as drugs . . . ." (Testimony given during hearings held on S. 5 by a subcommittee of the House Committee on Interstate and Foreign Commerce, 74th Cong., 1st Sess. (1935).16) Because of that incongruity as "pointed out by the Senate in the last consideration of the bill," the official explained, "[t]hey felt it proper to provide an independent definition of `devices.' " Thus, it is clear that two parallel definitions were provided for semantic reasons only; for the purposes of the Act, the two definitions had the same effect of subjecting both drugs and devices to the adulteration and misbranding provisions. No practical significance to the distinction between the two words arose until the pre-market clearance provisions, similar to the certification regulations for antibiotics enacted in 1945, were added after a drug tragedy in the fall of 1937.17 (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, 693-695 (1948); United States v. Dotterweich, 320 U.S. 277, 283-284 (1943).

IV.

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 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, 124-125 (1953)).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.

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 Congress suggested in the debates,19 such as electric belts, quack diagnostic scales, and therapeutic lamps, as well as bathroom weight scales, shoulder braces, air conditioning units, and crutches. In upholding the Secretary's determination here, without deciding the precise contours of the "device" classification, we need only point out that the exception was created primarily for the purpose of avoiding the semantic incongruity of classifying as drugs (1) certain quack contraptions and (2) basic aids used in the routine operation of a hospital—items characterized more by their purely mechanical nature than by the fact that they are composed of complex chemical compounds or biological substances. Finally, we are supported in the decision to uphold the FDA's determination that the sensitivity discs fall under the coverage of the Act and specifically under the drug provision thereof by the knowledge that the classification of these discs as drugs may not be as contrary to common medical usage as the District Court and respondent would have us believe.20

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, 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.

Reversed.

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.