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Squibb v. Weinberger

August 24, 1973

E. R. SQUIBB & SONS, INC., PETITIONER,
v.
CASPER W. WEINBERGER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, AND CHARLES C. EDWARDS, COMMISSIONER OF FOOD AND DRUGS, RESPONDENTS.



ON PETITION TO REVIEW AN ORDER OF THE FOOD AND DRUG ADMINISTRATION, UNITED STATES DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Author: Adams

Before: VAN DUSEN and ADAMS, Circuit Judges, and BARLOW, District Judge.

Opinion OF THE COURT

ADAMS, Circuit Judge:

This is an appeal from an order of the Food and Drug Administration (FDA) revoking the marketing approval previously granted for several drugs produced by E. R. Squibb & Sons, Inc. (Squibb), a major manufacturer of pharmaceuticals. The order also denied Squibb an evidentiary hearing before the FDA at which Squibb alleges it would produce substantial evidence of the safety and effectiveness of those drugs.

Consideration of the appeal was deferred with the concurrence of the parties, pending resolution by the U.S. Supreme Court of Weinberger v. Hynson, Wescott & Dunning, Inc., 412 U.S. 609, 93 S. Ct. 2469, 37 L. Ed. 2d 207, 41 U.S.L.W. 4848 (1973).*fn1 An understanding of the bearing of Hynson on this case requires a brief explication of the procedures adopted for evaluating drugs offered for sale to the public.

Prior to 1962, a company desiring to market a "new drug" was required by statute to submit to the FDA evidence demonstrating that the drug was safe for its intended use.*fn2 In 1962 the law was amended to insure that drugs sold would not only be safe but effective as well.*fn3 Manufacturers of drugs that had been marketed before 1962 were given a period of time, after which they were required to prove the effectiveness of the drugs or have their certifications withdrawn.*fn4 The 1962 amendment directed that the NDA be revoked "if 'substantial evidence' that the drug is effective for its intended use is lacking."*fn5 Section 355(d) of the statute defined "substantial evidence" as:

"... evidence consisting of adequate and well-controlled investigations, including clainical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...."*fn6

Faced with the necessity of reviewing the effectiveness of several thousand drugs that were on the market,*fn7 the FDA promulgated regulations providing for summary procedures for evaluating the drugs.*fn8 The companies that manufacture the drugs in question were required to submit "substantial evidence" of effectiveness. To carry out the statute's instruction that the investigations were to be "adequate and well-controlled," the FDA's regulations prescribed, with some specificity, the format and procedures to be followed in the studies submitted.*fn9 A submission in conformity with the FDA's regulations was considered to establish a prima facie showing of "substantial evidence" entitling a manufacturer to a hearing before the agency on the drug's asserted efficacy. Failure to conform to the standards was deemed to preclude a finding that there was substantial evidence of effectiveness. Such a determination would result in the conclusion that there existed no disputed issue requiring a hearing, and the drug's approval would be withdrawn summarily by the FDA.

Operating pursuant to these regulations, the FDA ordered manufacturers to furnish the studies required by ยง 355(d) and the FDA's regulations. In response, Hynson submitted evidence of effectiveness and moved for a hearing. The FDA held that Hynson's submission was inadequate and denied the requested hearing and sought to withdraw approval. Hynson challenged this denial, alleging that its submission met the standards entitling it to a hearing, and that in any event the regulations promulgated by the FDA were improper. The Supreme Court approved the FDA regulations, but held that Hynson's submission was sufficient to warrant a hearing.*fn10

As to the assault on the FDA's regulations, the Supreme Court pointed out that the administrative summary judgment procedure created by the regulations, and the standards established to determine the propriety of such a judgment, constituted an appropriate administrative interpretation of the "substantial evidence" requirement of the Act.

The Supreme Court went on to state the role of a court of appeals in reviewing orders of the FDA refusing hearings:

"In reviewing an order of the Commissioner [of the FDA] denying a hearing, a court of appeals must determine whether the Commissioner's findings accurately reflect the study in question and if they do, whether the deficiencies he finds conclusively render the study inadequate or uncontrolled in light of pertinent regulations."*fn11

Squibb, like Hynson, made a submission to the FDA in support of a request for a hearing. Its request was rejected. The FDA's order denying the hearing cited shortcomings in the literature provided by Squibb to prove efficacy. To apply the standard of review articulated by the Supreme Court, we must determine the correctness of the FDA's findings that the deficiencies conclusively establish ...


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