Bristol Laboratories v. Richardson, No. 71-1394.

• Citation: 456 F.2d 563
• Decision Date: 23 December 1971
• Docket Number: No. 71-1394.
• Parties: BRISTOL LABORATORIES, etc., Petitioner, v. Elliot L. RICHARDSON, Secretary of Health, Education and Welfare, et al., Respondents.
• Court: U.S. Court of Appeals — First Circuit

456 F.2d 563 (1971)

BRISTOL LABORATORIES, etc., Petitioner, v. Elliot L. RICHARDSON, Secretary of Health, Education and Welfare, et al., Respondents.

No. 71-1394.

United States Court of Appeals, First Circuit.

December 23, 1971.

Gilbert H. Weil, New York City, with whom Edward B. Hanify, Boston, Mass., was on motions and memorandum in support for petitioner.

Howard S. Epstein and Ira H. Leesfield, Attys., Dept. of Justice, and Eugene M. Pfeifer, Atty., Dept. of Health, Education and Welfare, for respondents.

ON MOTIONS FOR RETRANSFER, FOR LEAVE TO ADDUCE ADDITIONAL EVIDENCE, AND FOR STAY PENDING REVIEW

COFFIN, Circuit Judge.

This is a petition by a drug manufacturer, Bristol Laboratories, Division of Bristol-Myers Co. (Bristol), for a stay pending review of an order of the Commissioner of Food and Drugs (FDA) withdrawing certification of four of its fixed-combination prescription drugs — Tetrex-APC with Bristamin Capsules, Tetrex-AP Syrup, Syndecon Tablets and Syndecon for Oral Solution. The context of the present application is substantially similar to that detailed in American Cyanamid Co. v. Richardson, 1 Cir., 456 F.2d 509, opinion dated December 16, 1971, in which I denied a similar application for a stay. Hearing was had on the present application and briefs and the certified record were submitted and reviewed.

Petitioner points to several distinctions between its position and American Cyanamid's which, it vigorously asserts, justify different procedural and substantive treatment of the two applications. Bristol's major procedural challenge is directed to the propriety of the Third Circuit's transfer, pursuant to 28 U.S.C. § 2112(a), of its application for a stay to this court, there being no other jurisdictional tie between Bristol and this circuit. Bristol contends that the FDA Order of November 17, 1971, 36 F.R. 21879, review of which was sought here on December 10, 1971, by American Cyanamid, and in the Third Circuit on December 15, 1971, by Bristol, is not really a unitary order based on a unitary record within the intendment of § 2112(a), but is rather a series of orders, involving different manufacturers, drugs, and evaluations. It relies principally on Far East Conference v. Federal Maritime Commission, 119 U.S.App.D.C. 110, 337 F.2d 146 (1964), cert. denied, 379 U.S. 991, 85 S.Ct. 704, 13 L.Ed.2d 611 (1965), where petitions addressed to substantially similar but separate orders were not subjected to transfer, and Midwest Video Corp. v. United States, 362 F.2d 259 (8th Cir. 1966), where separate orders were addressed to different aspects of the cable television industry. It acknowledges that it has discovered no case in which the proposition was accepted that an order, single in form, may be treated as plural for purposes of the transfer statute.

The legislative history of 28 U.S.C. § 2112 sheds little direct light on the question: when, for transfer purposes, is an order not one but several? I hesitate to ignore the unitary label given the order at issue here, as well as the antecedents of that order in 1970 and 1969. My hesitation becomes conviction when I consider that the exercise engaged in by the FDA by means of these orders, encompassing a group of fifteen fixed-combination drugs having common characteristics and subject to common criticisms, was undertaken to achieve rational and comprehensive modification of FDA regulations governing certification of "drugs for oral use in man containing antibiotics in combination with antihistamines and/or analgesics and/or decongestants", 21 C.F.R. Parts 146a, 146c, 148m, and 148n. Two of the drugs here involved fall within Part 146a; the other two within Part 146c, as did those of American Cyanamid. Both American Cyanamid and Bristol have unavailingly sought FDA hearings on the acceptability of their drugs, the FDA concluding that neither had supplied the kind of data based on well-controlled clinical investigations...