Pfizer, Inc. v. Richardson, 217

• Citation: 434 F.2d 536
• Decision Date: 02 November 1970
• Docket Number: Docket 35177.,No. 217,217
• Parties: PFIZER, INC., Petitioner, v. Elliot L. RICHARDSON, Secretary of Health, Education and Welfare, and Charles C. Edwards, Commissioner of the Food and Drug Administration, Respondents.
• Court: United States Courts of Appeals. United States Court of Appeals (2nd Circuit)

434 F.2d 536 (1970)

PFIZER, INC., Petitioner, v. Elliot L. RICHARDSON, Secretary of Health, Education and Welfare, and Charles C. Edwards, Commissioner of the Food and Drug Administration, Respondents.

No. 217, Docket 35177.

United States Court of Appeals, Second Circuit.

Argued September 30, 1970.

Decided November 2, 1970.

William W. Goodrich, Asst. Gen. Counsel, Food, Drugs and Environmental Health Division (Will Wilson, Asst. Atty. Gen., Criminal Division, John L. Murphy, Chief, Administrative Regulations Section, Howard S. Epstein, Atty., U. S. Dept. of Justice, Washington, D. C., Joanne S. Sisk and Eugene M. Pfeifer, Attys., U. S. Dept. of Health, Education and Welfare, Rockville, Md., of counsel), for respondents.

William J. Manning, New York City (Simpson, Thacher & Bartlett, Albert X. Bader, Jr., Melvyn L. Cantor, Edward C. Mendrzycki, and Robert B. McKay, New York City, of counsel), for petitioner.

Before DANAHER,^* FRIENDLY and HAYS, Circuit Judges.

FRIENDLY, Circuit Judge:

This is a petition by Pfizer, Inc., a prominent pharmaceutical manufacturer, pursuant to § 701(f) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 371(f), here applicable by virtue of the last sentence of § 507(f), to review a final order of the Food and Drug Administration (FDA) issued July 14, 1970.¹ The order, made pursuant to § 507(f) of the Act, see fn. 3 infra, repealed regulations, first issued during the 1950's, authorizing the distribution of six antibiotic drugs manufactured by Pfizer and revoked all certificates of safety and effectiveness thereunder. The FDA took this action without granting Pfizer an evidentiary hearing upon its objections. It sought to justify this summary procedure on the basis of a finding that Pfizer had failed to state "reasonable grounds" for its objections within the meaning of § 507(f). Judge Anderson granted a stay of the order pending argument of the petition on an expedited schedule; at argument we extended the stay until the filing of an opinion.

All six of the drugs are to be taken orally. Three are called Signemycin and three Sigmamycin. All are "combination" drugs, containing two parts of tetracycline (or tetracycline hydrochloride), long and still approved antibiotics, and one part of triacetyloleandomycin (or oleandomycin phosphate), antibiotics also long and still approved. Since there is no contention that the case with respect to any of one of the preparations differs from the others, we shall follow the parties in referring to all six drugs as Signemycin.²

I.

It will be useful to begin with some history. Section 505 of the Federal Food, Drug and Cosmetic Act of 1938, 52 Stat. 1052-53, prohibited the introduction into interstate commerce of any drug unless an application therefor had become effective. Safety was the primary criterion for passing on such applications, § 505(d). Section 505(e) provided that once an application had become effective, it could be suspended, after due notice and opportunity for hearing to the applicant, if the Secretary, then of Agriculture, found that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when the application became effective showed that the drug was unsafe for use, or that the application contained any untrue statement of a material fact.

Seven years later Congress amended the Act to deal with the first of the antibiotics, penicillin, by enacting an entirely new provision, § 507, 59 Stat. 463-64. This empowered the Federal Security Administrator, to whom administration of the Food, Drug and Cosmetic Act had then been confided, to provide for the certification of batches of drugs composed of penicillin or its derivatives. He was to do this "if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use." Section 507(b) directed him to issue regulations providing for such certification. Section 507(f) stated that any interested person could apply for the issuance, amendment, or repeal of any such regulation, and any interested person could file objections to such action. The section went on to say, substantially as it still does, that if reasonable grounds for such objections had been stated, the Administrator was to hold a hearing thereon. No drug subject to § 507 was to be deemed subject to § 505. The teeth of the statute were an addition to § 502 of a new paragraph (l) making a penicillin drug not complying with § 507 a misbranded article. Subsequent amendments added four other named antibiotics and their derivatives, including in 1949 chlortetracycline, 63 Stat. 409-10. The net of all this was that while the standard antibiotics were not subject to the elaborate "new drug" procedures of § 505 as such, they were under even more stringent regulation in two respects. Certification of batches of antibiotic drugs was required, and the drugs had to meet a standard of efficacy as well as of safety.

In 1962 Congress substantially amended the Food, Drug and Cosmetic Act. Section 505 was greatly stiffened. The Secretary, now of Health, Education and Welfare, was authorized by § 505(d) to deny approval of a new drug not only if "he has insufficient information to determine whether such drug is safe for use * * *" but also if "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." The subsection provided that:

As used in this subsection and subsection (e) of this section, 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.

Section 505(e) authorized withdrawal of approval of an application not only for falsity or for considerations relating to safety, stated more broadly than in the 1938 Act, but also

on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that 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 labeling thereof.

However, withdrawal could be effected only "after due notice and opportunity for hearing to the applicant" except when the drug was found to be an immediate danger to public health, in which event the Secretary might suspend approval immediately and give the applicant an expedited hearing.

Section 507 was also amended. Section 507(a) was broadened to include all antibiotic drugs, which were defined. An entirely new section, 507(h), established a special procedure governing antibiotics previously approved under § 505, i. e., those antibiotics not specifically named in the pre-1962 version of § 507, and brought within the latter section for the first time under the 1962 revision. The initial issuance of regulations providing for their certification or exemption under § 507 was not to "be conditioned upon an affirmative finding of the efficacy of such drug." Any subsequent amendment or repeal of a regulation on the ground of a lack of efficacy could be effected

only if (1) such amendment or repeal is made in accordance with the procedure specified in subsection (f) of this section (except that such amendment or repeal may be initiated either by a proposal of the Secretary or by a petition of any interested person) and (2) the Secretary finds, on the basis of new information with respect to such drug evaluated together with the information before him when the application under section 505 became effective or was approved, that there is a lack of substantial evidence (as defined in section 505(d)) that the drug has the effect it purports or is represented to have under such conditions of use.

Section 507(f), which controls here, was left relatively unchanged; we quote it in full in the margin.³

The 1962 amendments presented the FDA with an enormous task of reviewing the efficacy of all new drugs that had been cleared, for safety only, between 1938 and October 10, 1962. On July 9, 1966, it announced, 31 F.R. 9426, an agreement to enlist the National Academy of Sciences-National Research Council (NAS-NRC) in this enterprise. The agreement also contemplated a survey of those antibiotic drugs like Signemycin, which had been certified or exempted from certification under § 507 prior to October 10, 1962. To implement this agreement with respect to antibiotics and to facilitate the task of the Council in determining whether any certification or release should be rescinded or any regulation under § 507 should be amended or repealed, the FDA, three months later, issued an order requiring each manufacturer to furnish specified information about the antibiotics in question. This included a "list of literature references most pertinent to an evaluation of the effectiveness of the drug for the purposes for which it is offered in the label, package insert, or brochure" accompanying its sale and "unpublished articles or other data pertinent to an evaluation of the claims." Pfizer responded with respect to the Signemycin products.

In the winter of 1969, a panel of six physicians, chaired by Dr. William Kirby, reported on its study of the Signemycin drugs. The conclusion was that they were "ineffective as a fixed combination." We quote as an example a portion...