Upjohn Company v. Finch
| Decision Date | 03 March 1970 |
| Docket Number | No. 19926.,19926. |
| Citation | 422 F.2d 944 |
| Parties | The UPJOHN COMPANY, Petitioner, v. Robert H. FINCH, Secretary of Health, Education & Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Respondents. |
| Court | U.S. Court of Appeals — Sixth Circuit |
Stanley L. Temko, Washington, D. C., Henry Ford, Jr., Kalamazoo, Mich., Herbert Dym, Washington, D. C., on brief; Ford, Kriekard, Brown & Staton, Kalamazoo, Mich., Covington & Burling, Washington, D. C., of counsel, for petitioner.
William W. Goodrich, Asst. Gen. Counsel, Food and Drug Administration, Washington, D. C., Eugene M. Pfeifer, Attorney, U. S. Department of Health, Education and Welfare, Washington, D. C., of counsel, for respondents.
Daniel Marcus, Wilmer, Cutler & Pickering, Washington, D. C., Bruce J. Brennan, Vice President & General Counsel, Pharmaceutical Manufacturers Assn., Washington, D. C., amici curiae.
Before PHILLIPS, Chief Judge, and EDWARDS and PECK, Circuit Judges.
This case is before the Court on the petition of the Upjohn Company (Upjohn) to review an order of the Commissioner of Food and Drugs (the Commissioner) under the 1962 Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq. The Commissioner and the Secretary of Health, Education and Welfare (the Secretary) are respondents. The order of the Commissioner was issued September 10, 1969, and was published in the Federal Register, 34 Fed.Reg. 14598, September 19, 1969. A copy of this order is made Appendix A to this opinion. The order denied an evidentiary hearing to Upjohn, repealed certain rules and regulations of the Commissioner and revoked certificates of safety and effectiveness previously issued involving seven fixed combination antibiotic drugs manufactured by Upjohn. The effect of this order of the Food & Drug Administration (FDA) is to forbid future sale and distribution of the drugs in question effective 30 days after publication in the Federal Register.
The petition to review is before this Court by authority of one of the 1962 amendments to the Act, 21 U.S.C.A. § 355(h). The petition was filed October 13, 1969, accompanied by a motion for a stay order pending review. On October 15, 1969, this Court heard oral arguments on the motion to stay. At that hearing the Commissioner through counsel agreed to suspend effectiveness of the order (Appendix A) until this Court has acted on the motion to stay.
On October 30, 1969, this Court on its own motion entered an order advancing the petition for review on the Court's docket and setting it for hearing in the forthcoming December 1969 session, to be considered along with the motion to stay which then was under advisement. This order recognized that the issues in this case are very significant both to the public and to the drug industry. The order provided that in event the Commissioner should see fit to withdraw his voluntary agreement staying effectiveness of his order until further order of this Court, five days advance notice should be given the Court of such contemplated withdrawal. No such notice has been received and the order has not yet been enforced against Upjohn.
Oral arguments on the merits of the petition to review were heard December 8, 1969. The Pharmaceutical Manufacturers Association filed a brief amicus curiae in support of the petition to review.
We affirm.
An exhaustive investigation of the drug industry was begun on December 7, 1959, by the subcommittee on Antitrust and Monopoly of the Senate Judiciary Committee. Extended hearings were conducted under the leadership of Senator Estes Kefauver of Tennessee, Chairman of the Subcommittee. On April 12, 1961, Senator Kefauver and Senator Philip E. Hart of Michigan introduced S.1552, from which the 1962 Amendments eventually evolved. A summary of the legislative history is attached as Appendix B to this opinion.
In discussing on the Senate floor the conference report on this legislation Senator Kefauver said: "Those in the future who attempt to study the legislative history of this measure as it passed through its various stages may be forgiven if they become somewhat confused." 108 Cong.Rec. 20868 (daily ed. Oct. 3, 1962).1 We find no confusion, however, as to those parts of this legislation which are before this Court for application in the present case.
In explaining the bill on the floor of the Senate, Senator James O. Eastland, Chairman of the Senate Judiciary Committee, stated that one of the principal features was to require "* * * that a new drug be shown to be effective, as well as safe, before it is cleared for the market, and authorize withdrawal of such a drug from the market if new evidence shows it to be ineffective." 108 Cong.Rec. 16303 (Aug. 23, 1962).
Congressman Bennett of Michigan said on the floor of the House:
108 Cong.Rec. 19,894 (Sept. 27, 1962).
The report of the House Committee states:
"An application will be withdrawn if, on the basis of new evidence, evaluated with that originally submitted, the Secretary finds that the drug is not shown to be safe, or if new information, evaluated together with other evidence, indicates that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have." H.R.Rep.No. 2164, 87th Cong., 2d Sess. 8.
The House Report further states:
"The Secretary could later amend or repeal the regulations on certifications on the ground of lack of efficacy of the drug under such conditions of use, on a finding that there is lack of substantial evidence that the drug has the effect it purports or is represented to have under such conditions of use." Ibid. p. 5.
Although the Senate and House bills differed in other particulars, the language of the bills relating to the effectiveness and safety of drugs was identical with one minor exception. 108 Cong.Rec. 20868. (Oct. 3, 1969).
21 U.S.C. § 355(e) authorizes the Secretary, after due notice and opportunity for hearing, to withdraw approval of an application with respect to any drug if the Secretary finds:
"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 or use prescribed, recommended, or suggested in the labeling thereof."
Manufacturers of drugs that previously have been subject to the new drug procedure were granted a two-year period of grace before such drugs could be ordered off the market on the sole ground of lack of substantial evidence of effectiveness for uses claimed for them by previously cleared labeling.
The purpose of the 1962 amendments was summarized as follows in Toledo L. Rev. 682 (1969):
This Court, speaking through Judge Martin in United States v. Two Bags, etc., 147 F.2d 123, 127 (6th Cir.1945), held that from its inception to its last amendment the purpose of the Pure Food, Drug & Cosmetic Act is "to protect the consuming public" and that the Act should be construed liberally so as to effectuate its purpose. This same rule of construction applies to the 1962 amendments.
The seven drugs manufactured by Upjohn which are involved in this proceeding are marketed under proprietary names as follows:
In 1956 the Commissioner promulgated regulations providing that certain antibiotic drugs containing a combination of tetracycline and novobiocin could be certified as safe and effective. 21 Fed. Reg. 10373. Upjohn's Panalba products were approved and certified by FDA as being both safe and effective in 1956. Marketing of Panalba began in 1957. The other Upjohn products involved in this case thereafter were certified by FDA as safe and effective.
To carry out FDA's responsibilities concerning the efficacy of drugs under the 1962 amendments that agency called upon the National Academy of Sciences — National Research Council (NASNRC) to establish a Drug Efficacy Study Group to review the claims of drug manufacturers for all drugs on the market and to make recommendations to FDA with respect to the drugs and drug claims. Information was published in 31 Fed.Reg. 9426, July 9, 1966, giving notice to the antibiotic drug industry pertaining to this agreement with NAS-NRC. Upjohn and other firms were directed to submit a special report which would include "the...
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