Source: https://supreme.justia.com/cases/federal/us/442/544/
Timestamp: 2019-04-24 12:45:19+00:00

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"any drug . . . not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
Finding t.hat Laetrile, in proper dosages, was nontoxic and effective, the District Court ordered the Government to permit limited purchases of the drug by one of the named plaintiffs. While not disturbing the injunction, the Court of Appeals instructed the District Court to remand the case to the Food and Drug Administration (FDA) for determination whether Laetrile was a "new drug" under § 201(p)(1), and, if so, whether it was exempt from premarketing approval under either of the Act's two grandfather clauses. After completion of administrative hearings, the Commissioner of the FDA found that Laetrile constituted a "new drug" as defined in § 201(p)(1) and fell within neither grandfather provision. On review of the Commissioner's decision, the District Court concluded that Laetrile was entitled to an exemption from premarketing approval under the Act's 1962 grandfather clause and, alternatively, that the Commissioner had infringed constitutionally protected privacy interests by denying cancer patients access to Laetrile. The Court of Appeals, without addressing either the statutory or constitutional rulings of the District Court, held that the Act's "safety" and "effectiveness" standards have "no reasonable application" to terminally ill cancer patients, and approved intravenous injections of Laetrile for such individuals.
Held: The Act makes no express exception for drugs used by the terminally ill, and no implied exemption is necessary to attain congressional objectives or to avert an unreasonable reading of the terms "safe" and "effective" in § 201(p)(1). Pp. 442 U. S. 551-559.
(a) Nothing in the legislative history suggests that Congress intended protection only for persons suffering from curable diseases. Moreover, in implementing the statutory scheme, the FDA has never exempted drugs used by the terminally ill. The construction of a statute by those charged with its administration is entitled to substantial deference, particularly where, as here, an agency's interpretation involves issues of considerable public controversy and Congress has not acted to correct any misperception of its statutory objectives. Pp. 442 U. S. 552-554.
(b) The Court of Appeals erred in concluding that the safety and effectiveness standards of § 201(p)(1) could have "no reasonable application" to terminal patients. For purposes of § 201(p)(1), the effectiveness of a drug does not necessarily denote capacity to cure; in the treatment of any illness, terminal or otherwise, a drug is effective if it fulfills, by objective indices, its sponsor's claims of prolonged life, improved physical condition, or reduced pain. Nor is the concept of safety under § 201(p)(1) without meaning for terminal patients; a drug is unsafe for the terminally ill, as for anyone else, if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit. Finally, construing § 201(p)(1) to encompass treatments for terminal diseases does not foreclose all resort to experimental cancer drugs by patients for whom conventional therapy is unavailing. That § 505(i) of the Act makes explicit provision for carefully regulated use of certain drugs not yet demonstrated to be safe and effective reinforces the conclusion that no exception for terminal patients may be judicially implied. Pp. 442 U. S. 554-559.
The question presented in this case is whether the Federal Food, Drug, and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as "safe and effective" within the meaning of § 201(p)(1) of the Act, 52 Stat. 1041, as amended, 21 U.S.C. § 321 (p)(1).
qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. . . . "
In 1975, terminally ill cancer patients and their spouses brought this action to enjoin the Government from interfering with the interstate shipment and sale of Laetrile, a drug not approved for distribution under the Act. [Footnote 4] Finding that Laetrile, in proper dosages, was nontoxic and effective, the District Court ordered the Government to permit limited purchases of the drug by one of the named plaintiffs. 399 F.Supp.
1208, 1215 (WD Okla.1975). [Footnote 5] On appeal by the Government, the Court of Appeals for the Tenth Circuit did not disturb the injunction. However, it instructed the District Court to remand the case to the Food and Drug Administration for determination whether Laetrile was a "new drug" under § 201(p)(1), and, if so, whether it was exempt from premarketing approval under either of the Act's grandfather clauses. 542 F.2d 1137 (1976).
Having determined that Laetrile was a new drug, the Commissioner proceeded to consider whether it was exempt from premarketing approval under the 1938 or 1962 grandfather provisions. On the facts presented, the Commissioner found that Laetrile qualified under neither clause. See id. at 39787-39795. First, there was no showing that the drug currently known as Laetrile was identical in composition or labeling to any drug distributed before 1938. See 21 U.S.C. § 321(p)(1); n. 3, supra. Nor could the Commissioner conclude from the evidence submitted that, as of October 9, 1962, Laetrile in its present chemical composition was commercially used or sold in the United States, was generally recognized by experts as safe, and was labeled for the same recommended uses as the currently marketed drug. See § 107(c)(4), 76 Stat. 789; n. 3, supra.
On review of the Commissioner's decision, the District Court sustained his determination that Laetrile, because not generally regarded as safe or effective, constituted a new drug under § 201(p)(1). 438 F.Supp. 1287, 1293-1294 (WD Okla.1977). The court also approved the Commissioner's denial of an exemption under the 1938 grandfather clause. However, concluding that the record did not support the Commissioner's findings as to the 1962 grandfather provision, the District Court ruled that Laetrile was entitled to an exemption from premarketing approval requirements. Id. at 1294-1298. Alternatively, the court held that, by denying cancer patients the right to use a nontoxic substance in connection with their personal health, the Commissioner had infringed constitutionally protected privacy interests. Id. at 1298-1300.
Tenth Circuit held that "the safety' and `effectiveness' terms used in the statute have no reasonable application to terminally ill cancer patients." 582 F.2d 1234, 1236 (1978). Since those patients, by definition, would "die of cancer regardless of what may be done," the court concluded that there were no realistic standards against which to measure the safety and effectiveness of a drug for that class of individuals. Id. at 1237. The Court of Appeals therefore approved the District Court's injunction permitting use of Laetrile by cancer patients certified as terminally ill. However, presumably because the Commissioner had found some evidence that Laetrile was toxic when orally administered, see 42 Fed.Reg. 39786-39787 (1977), the Court of Appeals limited relief to intravenous injections for patients under a doctor's supervision. 582 F.2d at 1237. In addition, the court directed the FDA to promulgate regulations "as if" the drug had been found "`safe' and `effective'" for terminally ill cancer patients. Ibid.
"[a]ny drug . . . not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
See supra at 442 U. S. 546-547.
When construing a statute so explicit in scope, a court must act within certain well defined constraints. If a legislative purpose is expressed in "plain and unambiguous language, . . . the . . . duty of the courts is to give it effect according to its terms." United States v. Lexington Mill & Elevator Co., 232 U. S. 399, 232 U. S. 409 (1914). See Andrus v. Sierra Club, ante, p. 442 U. S. 347.
Exceptions to clearly delineated statutes will be implied only where essential to prevent "absurd results" or consequences obviously at variance with the policy of the enactment as a whole. Helvering v. Hammell, 311 U. S. 504, 311 U. S. 510-511 (1941). See TVA v. Hill, 437 U. S. 153, 437 U. S. 187-188 (1978); United States v. Key, 397 U. S. 322, 397 U. S. 324-325 (1970); United States v. American Trucking Assns., 310 U. S. 534, 310 U. S. 543-544 (1940). In the instant case, we are persuaded by the legislative history and consistent administrative interpretation of the Act that no implicit exemption for drugs used by the terminally ill is necessary to attain congressional objectives or to avert an unreasonable reading of the terms "safe" and "effective" in § 201(p)(1).
Corp., 439 U. S. 234, 439 U. S. 248 (1978); Bayside Enterprises, Inc. v. NLRB, 429 U. S. 298, 429 U. S. 304 (1977); Udall v. Tallman, 380 U. S. 1, 380 U. S. 16 (1965). Such deference is particularly appropriate where, as here, an agency's interpretation involves issues of considerable public controversy, and Congress has not acted to correct any misperception of its statutory objectives. See Red Lion Broadcasting Co. v. FCC, 395 U. S. 367, 395 U. S. 381 (1969); Zemel v. Rusk, 381 U. S. 1, 381 U. S. 11-12 (1965). [Footnote 10] Unless and until Congress does so, we are reluctant to disturb a longstanding administrative policy that comports with the plain language, history, and prophylactic purpose of the Act.
standards set forth in § 201(p)(1) could have "no reasonable application" to terminally ill patients. 582 F.2d at 1236. We disagree. Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy. See Anderson v. Wilson, 289 U. S. 20, 289 U. S. 27 (1933). Only when a literal construction of a statute yields results so manifestly unreasonable that they could not fairly be attributed to congressional design will an exception to statutory language be judicially implied. See TVA v. Hill, 437 U.S. at 437 U. S. 187-188. Here, however, we have no license to depart from the plain language of the Act, for Congress could reasonably have intended to shield terminal patients from ineffectual or unsafe drugs.
A drug is effective within the meaning of § 201(p)(1) if there is general recognition among experts, founded on substantial evidence, that the drug in fact produces the results claimed for it under prescribed conditions. See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. at 412 U. S. 629-634; n 7, supra. Contrary to the Court of Appeals' apparent assumption, see 582 F.2d at 1236, effectiveness does not necessarily denote capacity to cure. In the treatment of any illness, terminal or otherwise, a drug is effective if it fulfills, by objective indices, its sponsor's claims of prolonged life, improved physical condition, or reduced pain. See 42 Fed.Reg. 39776-39786 (1977).
the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit. Indeed, the Court of Appeals implicitly acknowledged that safety considerations have relevance for terminal cancer patients by restricting authorized use of Laetrile to intravenous injections for persons under a doctor's supervision. See 582 F.2d at 1237; supra at 551.
"would lead to needless deaths and suffering among . . . patients characterized as 'terminal' who could actually be helped by legitimate therapy."
toxic or ineffectual, for such individuals. If history is any guide, this new market would not be long overlooked. Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and "Fountain of Youth" mixtures of spices, oil, and suet. [Footnote 16] In citing these examples, we do not, of course, intend to deprecate the sincerity of Laetrile's current proponents, or to imply any opinion on whether that drug may ultimately prove safe and effective for cancer treatment. But this historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise.
35 n. 23. That the Act makes explicit provision for carefully regulated use of certain drugs not yet demonstrated safe and effective reinforces our conclusion that no exception for terminal patients may be judicially implied. Whether, as a policy matter, an exemption should be created is a question for legislative judgment, not judicial inference.
"(a) . . . No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) of this section is effective with respect to such drug."
"(b) . . . Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a) of this section. Such person shall submit to the Secretary as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use. . . . "
"(d) . . . If the Secretary finds . . . that (1) the investigations . . . required to be submitted to the Secretary . . . do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; . . . (4) . . . he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) . . . there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. . . . As used in this subsection . . . , the term 'substantial evidence' means evidence consisting of adequate and well controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof."
The Secretary has delegated his approval authority to the Commissioner of the Food and Drug Administration. See 21 CFR § 5.1(a)(1) (1978).
The requirements for investigative use are set forth in § 505(i) of the Act, 21 U.S.C. § 355(i). See n 1, supra.
"In the case of any drug which, on the day immediately preceding the enactment date [October 10, 1962], (A) was commercially used or sold in the United States, (b) was not a new drug as defined by section 201(p) of the basic Act as then in force, and (C) was not covered by an effective [new drug] application under section 505 of that Act, the amendments to section 201(p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day."
§ 107(c)(4), 76 Stat. 789.
The suit was originally instituted by a cancer patient, Juanita Stowe, and her husband, Jimmie Stowe. After Ms. Stowe's death, two other patients, Glen L. Rutherford and Phyllis S. Schneider, and Ms. Schneider's husband, filed an amended complaint on behalf of a class composed of all cancer patients and spouses responsible for the costs of treatment. By order entered April 8, 1977, the District Court certified a class consisting of terminally ill cancer patients. 429 F.Supp. 506 (WD Okla.). The Government did not seek review of that order.
The District Court subsequently entered similar orders for other individuals who submitted affidavits averring their membership in the certified class of terminally ill cancer patients. See App. 1-6.
The Commissioner initiated proceedings with an announcement in the Federal Register seeking public comment. 42 Fed.Reg. 10066-10069 (1977). Notice was also afforded to certain known proponents of Laetrile. See id. at 39785-39786.
The Act does not define what constitutes general recognition of a drug's safety and effectiveness under § 201(p)(1). However, based on the structure and purpose of the statutory scheme, this Court, in Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. at 412 U. S. 629-634, interpreted § 201(p)(1) to require an "expert consensus" on safety and effectiveness founded upon "substantial evidence" as defined in § 505(d) of the Act, 21 U.S.C. § 355(d). See 442 U. S. 1, supra.
Under the 1938 Act, a "new drug" was one not generally recognized by qualified experts as safe for its recommended use. § 201(p)(1), 52 Stat. 1041. The Drug Amendments of 1962, Pub.L. 87-781, 76 Stat. 789, redefined the term to include drugs not generally recognized as effective or safe for their intended use. § 201(p)(1), 21 U.S.C. § 321(p)(1). See supra at 442 U. S. 546-547, 442 U. S. 551. In addition, the Amendments provided that no new drug application may be approved absent substantial evidence that the drug is effective as well as safe under prescribed conditions. § 505(d), 21 U.S.C. § 355(d). See n 1, supra.
"The Food and Drug Administration now requires, in determining whether a 'new drug' is safe, a showing as to the drug's effectiveness where the drug is offered for use in the treatment of a life-threatening disease, or where it appears that the 'new drug' will occasionally produce serious toxic or even lethal effects, so that only its usefulness would justify the risks involved in its use. In such cases, the determination of safety is, in the light of the purposes of the new drug provisions, considered by the Food and Drug Administration to be inseparable from consideration of the drug's effectiveness. The provisions of the bill are in no way intended to affect any existing authority of the Department of Health, Education, and Welfare to consider and evaluate the effectiveness of a new drug in the context of passing upon its safety."
S.Rep. No. 1744, 87th Cong., 2d Sess., pt. 1, p. 15 (1962). See also H.R.Rep. No. 2464, 87th Cong., 2d Sess., 3 (1962).
"If the drug is offered for treatment of progressive or life-threatening diseases, such as cancer, . . . we now consider its effectiveness. In such cases, the determination of safety is, in the light of the purpose of the new drug provisions, inseparable from consideration of the drug's effectiveness."
Hearings on S. 1552 before the Subcommittee on Antitrust and Monopoly of the Senate Committee on the Judiciary, 87th Cong., 1st Sess., 2588 (1961).
To be sure, it may not always be realistic to infer approval of a judicial or administrative interpretation from congressional silence alone. See, e.g., Helvering v. Hallock, 309 U. S. 106, 309 U. S. 119-121 (1940); Toucey v. New York Lie Ins. Co., 314 U. S. 118, 314 U. S. 140-141 (1941). But once an agency's statutory construction has been "fully brought to the attention of the public and the Congress," and the latter has not sought to alter that interpretation, although it has amended the statute in other respects, then presumably the legislative intent has been correctly discerned. Apex Hosiery Co. v. Leader, 310 U. S. 469, 310 U. S. 487-489 (1940). See United States v. Bergh, 352 U. S. 40, 352 U. S. 46-47 (1956). See, e.g., Pub.L. 94-295, 90 Stat. 575; Pub.L. 94-278, 90 Stat. 411; and Pub.L. 91-513, 84 Stat. 1281 (amending § 201 of the Act, 21 U.S.C. § 321).
The issue presented in this case plainly has not escaped public or legislative notice. Whether Laetrile should be freely accessible to cancer patients has been a frequent subject of political debate. Seventeen States have legalized the prescription and use of Laetrile for cancer treatment within their borders, and similar statutes have been defeated in 14 other States. See CCH F.D.Cosm.L.Rep. ¦ 42,292 (1978); Comment, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, 127 U.Pa.L.Rev. 233, 234 n. 8 (1978). That Congress is aware of the FDA's policy concerning Laetrile is evident from Senate Subcommittee hearings on the Commissioner's 1977 ruling. See Hearing before the Subcommittee on Health and Scientific Research of the Senate Committee on Human Resources, 95th Cong., 1st Sess. (1977).
See L. Goodman & A. Gilman, The Pharmacological Basis of Therapeutics 325-339 (5th ed. 1975).
See statement of Dr. Theodore Klumpp, Chief, Drug Division, FDA, June 23, 1941, CCH F.D.Cosm.L.Rep. ¦ 71,053.59 (1977); n 13, infra.
See, e.g., 42 Fed.Reg. 39768, 39787 (1977) (statement of Dr. Carl Leventhal, Deputy Director of the Bureau of Drugs, FDA, and Assistant Professor of Neurology and Pathology at Georgetown University) ("The safety of a drug for human use depends, in large measure, on the therapeutic effectiveness of the particular drug. . . . In the case of cancer, treatment with an ineffective drug will . . . inexorably lead to the patient's death"); ibid. (statement of Dr. George J. Hill II, Chairman of the Department of Surgery at Marshall University School of Medicine, W.Va.) (Ineffectual treatment can lead to delay in accepted modes of therapy and needless deaths; thus, "[i]n the absence of scientific evidence of effectiveness, no drug intended for use in treating cancer can be regarded as safe").
See, e.g., id. at 39805 (statement of Dr. Peter Wiernik, Chief of the Clinical Oncology Branch of the National Cancer Institute's Baltimore Research Center) ("[N]o one can prospectively define the term terminal' with any accuracy. A patient can be said to be terminal only after he dies. Many patients who are critically ill respond to modern day management of cancer"); ibid. (statement of Dr. Joseph Ross, Professor of Medicine, University of California School of Medicine at Los Angeles) ("[T]he distinction of `terminal' patients from `non-terminal' patients may not be reliably determined, and an assumption that Laetrile may be given to [`terminal'] patients with impunity may deprive such patients of therapeutic measures which could help them").
The Commissioner noted that these unexpected behavior patterns may account for anecdotal claims of Laetrile's effectiveness. Users of Laetrile who experience spontaneous remissions or delayed responses to conventional therapy after its abandonment may ascribe their improvement to Laetrile without any objective basis for that attribution. See, e.g., id. at 39777 (statement of Dr. Daniel S. Martin, researcher in cancer immunology and chemotherapy); id. at 39800 (statement of Dr. Emil J. Frereich, Chief of the Division of Oncology at University of Texas Medical School at Houston); ibid. (statement of Dr. Melvin Krant, Director of Cancer Project at the University of Massachusetts Medical Center). Particularly since accepted cancer treatments such as chemotherapy and radiation often have painful side effects, the Commissioner concluded that patients who subjectively perceive improvement after substituting Laetrile for these modes of therapy may erroneously believe that their condition has been arrested or ameliorated. See id. at 39777, 39799-39800.
CCH Fed.F.D.Cosm.L.Admin.Reps., 1907-1949, p. 745 (1951); id. at 1408; id. at 1170-1171, 1298-1299; id. at 224; FDA Ann. Reps., 1950-1974, pp. 309, 464; id. at 45; id. at 412.
See n 1, supra. At present, some 300 experimental drugs are available to critically ill cancer patients at authorized institutions. See Brief for United States 34 n. 23; National Cancer Institute, Extramural Clinical Trial Programs of the Division of Cancer Treatment, General Overview and Scope of Contract-Supported Activities (1979). During 1977, over 90,000 cancer patients participated in investigative programs under the auspices of the National Cancer Institute or the Veterans' Administration. Brief for United States 35 n. 23.
Respondents urge that we consider the District Court's rulings on the constitutional and grandfather clause questions as alternative bases for sustaining the judgment below. However, since the Court of Appeals addressed neither issue, we remand the case for further consideration of respondents' claims. See Vermont Yankee Nuclear Power Corp. v. National Resources Defense Council, Inc., 435 U. S. 519, 435 U. S. 549 (1978); Arlington Heights v. Metropolitan Housing Dev. Corp., 429 U. S. 252, 429 U. S. 271 (1977).

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