Weinberger v. Hynson, Wescott & Dunning, Inc., 412 U.S. 609 (1973)

Weinberger v. Hynson, Wescott & Dunning, Inc

No. 72-394

Argued April 17, 1973
Decided June 18, 1973 *
412 U.S. 609

CERTIORARI TO THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

Syllabus

The Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962, establishes a system of pre-marketing 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given two years to develop substantial evidence of effectiveness during which previously approved NDA’s could not be withdrawn by FDA for the drug’s lack of effectiveness.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 preceding 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. 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 NASNRC 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 investigation, 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; FPC v. Texaco, 377 U.S. 33. 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.

DOUGLAS, J., delivered the opinion of the Court, in which BURGER, C. .J., and WHITE, MARSHALL, BLACKMUN, and REHNQUIST, JJ., joined. POWELL, J., filed an opinion concurring in the result as to Part I and joining in Part II of the Court’s opinion, post, p. 637. BRENNAN, J., took no part in the consideration or decision of the cases. STEWART, J., took no part in the decision of the cases.