Weinberger v. Hynson, Westcott and Dunning, Incorporated Hynson, Westcott and Dunning, Incorporated v. Weinberger 8212 394, 72 8212 414

• Citation: 93 S.Ct. 2469,412 U.S. 609,37 L.Ed.2d 207
• Decision Date: 18 June 1973
• Docket Number: Nos. 72,s. 72
• Parties: Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. Petitioners, v. HYNSON, WESTCOTT AND DUNNING, INCORPORATED. HYNSON, WESTCOTT AND DUNNING, INCORPORATED, Petitioner, v. Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. —394, 72—414
• Court: United States Supreme Court

412 U.S. 609

93 S.Ct. 2469

37 L.Ed.2d 207

Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. Petitioners,

v HYNSON, WESTCOTT AND DUNNING, INCORPORATED.

HYNSON, WESTCOTT AND DUNNING, INCORPORATED, Petitioner,

v. Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al.

Nos. 72—394, 72—414.

Argued April 17, 1973.

Decided June 18, 1973.

Syllabus

The Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962, establishes a system of premarketing clearance for drugs and prohibits in § 505 (a) the introduction into commerce of any 'new drug' unless a new drug application (NDA) filed with the Food and Drug Administration (FDA) was effective with respect to such drug. Under the Act procedures were established for filing 'new drug' applications not only for the safety of drugs but for their efficacy as well. Standards were provided under which, after notice and hearing, FDA could refuse to allow an NDA to become effective, or could suspend an NDA in effect on the basis of new evidence that the drug was not effective. FDA is directed to refuse approval of an NDA and to withdraw prior approval if 'substantial evidence' (§ 505(d)) that the drug is effective for its intended use is lacking. All NDA's 'effective' prior to 1962 were deemed 'approved' and manufacturers were given two years to develop substantial evidence of effectiveness during which previously approved NDA's could not be withdrawn by FDA for the drug's lack of effectiveness. The 1962 Act also contained a 'grandfather' clause exempting from the effectiveness requirements any drug which on the day proceeding enactment (1) was commercially used or sold in the United States, (2) was not a 'new drug' as defined in the 1938 Act, and (3) 'was not covered by an effective application' for a new drug under the 1938 Act. The FDA had permitted more than 9,000 NDA's to become effective between 1938 and 1962, of which some 4,000 were still on the market. Additionally, manufacturers have marketed thousands of 'me-too' drugs without applying for clearance, drugs similar or identical to drugs with effective NDA's, marketed in reliance on the 'pioneer' drug application approved by FDA. To aid it in fulfilling the statutory mandate to review all marketed drugs, whether or not previously approved, for their efficacy, FDA retained the National Academy of Sciences-National Research Council (NAS—NRC) to create expert panels to review by class the efficacy of each approved drug. Holders of NDA's were invited to furnish the panels with the best available data to establish efficacy and FDA announced that it would apply NAS—NRC efficacy findings to all drugs, including the 'me-too' drugs. Respondent in No. 72—394 (Hynson) had filed an application for a drug called Lutrexin under the 1938 Act. FDA informed Hynson that the studies submitted with the application were not sufficiently well controlled to justify the claims of effectiveness, but allowed the application to become effective since the 1938 Act permitted evaluation of a new drug solely on the basis of its safety. When the 1962 amendments became effective Hynson submitted evidence of the efficacy of the drug, but the NAS—NRC panel reported that Hynson had not satisfied the requirements. Notice of an intention to withdraw approval of the NDA's covering the drug was given by the Commissioner of Food and Drugs. Before the hearing, Hynson brought suit in the District Court for a declaratory judgment that the drug was exempt from the efficacy review provisions of the 1962 Act, or that there was no lack of substantial evidence of the drug's efficacy. Petitioners' motion to dismiss was granted. While the District Court litigation was pending, the Commissioner denied Hynson's request for a hearing based on claims of 'substantial evidence' of Lutrexin's effectiveness, and withdrew the NDA for the drug, ruling that it was not exempt from the 1962 amendments and that Hynson had not submitted adequate evidence that the drug was not a new drug or was effective. The Court of Appeals reversed, holding that while the drug was not exempt, Hynson was entitled to a hearing on the substantial-evidence issue. No. 72 414 is a cross-petition by Hynson from the judgment of the Court of Appeals, which suggested that only a district court has authority to determine whether Lutrexin is a 'new drug.' While Hynson agrees that the Commissioner has authority to determine new drug status in proceedings to withdraw approval of the product's NDA, some manufacturers, parties to other suits in this group of cases, advance the contrary view. Held:

1. The 1962 amendments and the regulations issued thereunder, which express well-established principles of scientific in- vestigation, in their reduction of the 'substantial evidence' standard to detailed guidelines for the protection of the public, make FDA's so-called administrative summary judgment procedure appropriate. Pp. 617—619.

2. FDA's procedure, whereby it will not provide a formal hearing when it is apparent at the threshold that the applicant has not tendered any evidence which on its face meets the statutory standards as particularized by the regulations, is valid. United States v. Storer Broadcasting Co., 351 U.S. 192, 76 S.Ct. 763, 100 L.Ed. 1081; FPC v. Texaco, Inc., 377 U.S. 33, 84 S.Ct. 1105, 12 L.Ed.2d 112. Pp. 620—622.

3. In No. 72—394, the Court of Appeals' holding that Hynson was entitled to a hearing on whether its submission of evidence satisfied its threshold burden of providing 'substantial evidence' is affirmed. Pp. 622—623.

4. The heart of the statutory procedure is the grant of primary jurisdiction to FDA, subject to judicial review when administrative remedies are exhausted. Pp. 623—627.

5. Although a drug can be 'generally recognized' by experts as effective for intended use within the meaning of the Act only when that expert consensus is founded upon 'substantial evidence,' any ruling on Lutrexin's 'new drug' status is premature, and must await the outcome of the hearing on whether Hynson submitted 'substantial evidence,' as held in No. 72—394 (item 3, supra). Pp. 628—632.

6. Lutrexin is not exempt under the 'grandfather' provisions of the 1962 Act, as held by FDA and the Court of Appeals, and their construction accords with the legislative history which suggests that the exemption is afforded only for drugs that never had been subject to new drug regulation. Pp. 632—634.

461 F.2d 215, affirmed as modified.

Opening statement by Daniel M. Friedman, Washington, D.C., for Caspar W. Weinberger, Secretary, HEW, in all five cases.

Andrew L. Frey, Washington, D.C., for Weinberger, and others.

Edward Brown Williams, Washington, D.C., for Hynson, Westcott and Dunning, Incorporated.

Mr. Justice DOUGLAS delivered the opinion of the Court.

These cases, together with Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235; CIBA Corp. v. Weinberger, 412 U.S. 640, 93 S.Ct. 2495, 37 L.Ed.2d 230, and USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244, all here on certiorari, raise a series of questions under the 1962 amendments¹ to the Federal Food, Drug, and Cosmetic Act of 1938. 52 Stat. 1040. The 1938 Act, which established a system of premarketing clearance for drugs, prohibited the introduction into commerce of any 'new drug' unless a new drug application (NDA) filed with the Food and Drug Administration (FDA)² was effective with respect to that drug. § 505(a), 52 Stat. 1052. Under the 1938 Act a 'new drug' was one not generally recognized by qualified experts as safe for its intended use. § 201(p)(1). The Government could sue to enjoin violations, prosecute criminally, and seize and condemn the articles. §§ 301(d), 302(a), 303, 304. The Act established procedures for filing NDA's, § 505(b), and provided standards under which, after notice and hearing, FDA could refuse to allow an NDA to become effective, § 505(c) and (d), or could suspend an NDA in effect on the basis of new evidence that the drug was unsafe. § 505(e). Orders denying or suspending an NDA could be reviewed in a district court on the administrative record. § 505(h).

The 1962 Act amended § 201(p)(1) of the 1938 Act to define a 'new drug' as a drug not generally recognized among experts as effective as well as safe for its intended use. 21 U.S.C. § 321(p)(1). A new drug, as now defined, still may not be marketed unless an NDA is in effect. FDA is now directed to refuse approval of an NDA and to withdraw any prior approval if 'substantial evidence' ³ that the drug is effective for its intended use is lacking. 21 U.S.C. § 355(d) and (e). Thus, the basic clearance system, requiring FDA approval of an NDA before a 'new drug' may be lawfully marketed, was continued, except that FDA now either must approve or disapprove an application within 180 days. 21 U.S.C. § 355(c). (Under the 1938 Act an application automatically became effective if it was not disapproved.) Judicial review was transferred to the courts of appeals. 21 U.S.C. § 355(h).

Since the Act as amended requires affirmative agency approval, all NDA's 'effective' prior to 1962 were deemed 'approved' under the new definition, and manufacturers were given two years to develop substantial evidence of effectiveness, during which previously approved NDA's could not be withdrawn by FDA for a drug's lack of effectiveness.⁴ The 1962 amendments also contain a 'grandfather' clause exempting from the effectiveness requirements any drug which on the day preceding enactment (1) was commercially used or sold in the United States, (2) was not a 'new drug' as defined in the 1938 Act (it being generally recognized as safe), and (3) 'was not covered by an effective application' for a new drug under the 1938 Act.⁵

Between 1938 and 1962 FDA had permitted 9,457 NDA's to become effective. Of these, some 4,000 were still on the market. In addition, there were thousands of...