Hynson, Westcott and Dunning, Inc. v. Richardson, No. 71-1717.

CourtUnited States Courts of Appeals. United States Court of Appeals (4th Circuit)
Writing for the CourtBUTZNER, RUSSELL and FIELD, Circuit
PartiesHYNSON, WESTCOTT AND DUNNING, INCORPORATED, Petitioner, v. Elliot RICHARDSON, Secretary of Health, Education and Welfare and Charles C. Edwards, Commissioner of Food and Drugs, Respondents.
Decision Date24 May 1972
Docket NumberNo. 71-1717.

461 F.2d 215 (1972)

HYNSON, WESTCOTT AND DUNNING, INCORPORATED, Petitioner,
v.
Elliot RICHARDSON, Secretary of Health, Education and Welfare and Charles C. Edwards, Commissioner of Food and Drugs, Respondents.

No. 71-1717.

United States Court of Appeals, Fourth Circuit.

Argued February 7, 1972.

Decided May 24, 1972.


461 F.2d 216
COPYRIGHT MATERIAL OMITTED
461 F.2d 217
Edward Brown Williams, Washington, D. C. (Jan Edward Williams and Harter, Calhoun & Williams, Washington, D. C., Robert H. Patterson, Jr., and McGuire, Woods & Battle, Richmond, Va., and John Kyle Worley on brief), for petitioner

Gregory B. Hovendon, Atty., Dept. of Justice (Richard W. McLaren, Asst. Atty. Gen., and Peter Barton Hutt, Asst. Gen. Counsel, Food, Drugs and Environmental Health Division, Eugene M. Pfeifer, Atty., U. S. Dept. of Health, Education, and Welfare, on brief), for respondents.

Joel E. Hoffman, Washington, D. C. (Robert L. Wald, Selma M. Levine, and Wald, Harkrader & Ross, Washington, D. C., on brief), for amicus curiae.

Before BUTZNER, RUSSELL and FIELD, Circuit Judges.

DONALD RUSSELL, Circuit Judge:

The appellant, a drug manufacturer, seeks review of a final order withdrawing marketing approval (NDA) of the drug Lutrexin by the Commissioner of Food and Drugs, Department of Health, Education and Welfare.1 The appellant alleges error in such order of withdrawal (1) for failure to sustain its claim of exemption from withdrawal on account of lack of "substantial evidence" of effectiveness of its drug and, if this claim of exemption is overruled, (2) for denial of a hearing, as required under the applicable statute, on its showing of effectiveness. We reverse.

The appellant was granted an approved NDA for Lutrexin in 1952. At that time, the Food, Drug and Cosmetic Act of 1938 conditioned such grant on general recognition of safety of the drug approved. In 1962 the Act was amended to authorize withdrawal of an approved NDA for any drug for which the Commissioner "after due notice and opportunity for hearing", found there was "a lack of substantial evidence" of effectiveness.2 The term "substantial evidence" was defined in the Amendments as "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."3 There was an exemption from these requirements for drugs, which, inter alia, were not covered on the day immediately

461 F.2d 218
before the enacting date of the Amendments (i. e., October 9, 1962) by an "effective NDA".4

In carrying out his new responsibilities under the Amendments, the Commissioner secured the services of the National Academy of Sciences-National Research Council (NAS-NRC) for reviewing the claims of effectiveness on behalf of any drugs NDA'd between 1938 and 1962.5 To facilitate its assignment, NAS-NRC set up a Drug Efficacy Study Group and all drug manufacturers with approved NDAs obtained between 1938 and 1962 were directed by the Commissioner to submit to this Group evidence "pertinent to the evaluation of the effectiveness of the(ir) drugs."6 The appellant submitted to the Group clinical data, investigations and studies in support of the effectiveness for its drug Lutrexin. After considering such data, NAS-NRC concluded that Lutrexin was "possibly effective" but indicated the supporting documentation was inadequate. The Commissioner advised the appellant of his concurrence with the conclusions of NAS-NRC and, as required by the statute, extended to it an opportunity for a hearing on the proposed withdrawal of the approved NDA for Lutrexin.7 At such a hearing, the appellant was advised it might "produce evidence and arguments why approval * * * should not be withdrawn."8 The appellant in due time requested such hearing. Under the Commissioner's regulations, a hearing was required within 90 days after such request, unless the parties agreed otherwise.9 However, although no delay was agreed on, hearing within such period was not had. The delay on the part of the Commissioner in setting a hearing was due to litigation over the procedure to be followed by the Commission in implementing its efficacy review and in conducting hearings resulting therefrom.10 It is unnecessary to review the difficulties encountered in developing valid regulations for such hearings. It is sufficient for the issues here that it was not until May 8, 1970, that the legal objections to the regulations were finally resolved. During this interregnum when the regulations of the Agency were under challenge and the Commissioner was delaying a hearing, the appellant, whose request for a hearing had been delayed for more than a year, sought in District Court a declaratory judgment to the effect that, under the exemption clause included in the 1962 Amendments, Lutrexin was not a "new drug" on and before October 10, 1962, and was thereby exempt from the requirement of evidence of effectiveness under the Amendments. Such action was dismissed on the ground that primary jurisdiction to resolve the issue of exemption under the Act rested with the Commissioner. No appeal was taken from this dismissal.

While this declaratory action was pending, the Commissioner issued his new regulations detailing the circumstances under which an applicant might secure a hearing on a proposal by the Commissioner for withdrawal of an effective

461 F.2d 219
NDA. By these regulations, the Commissioner was authorized to deny a hearing, "When it clearly appears from the data in the application and from the reasons and factual analysis in the request for the hearing that there is no genuine and substantial issue of fact which precludes the refusal to approve the application or the withdrawal of approval of the application, e. g., no adequate and well-controlled clinical investigations to support the claims of effectiveness have been identified, the Commissioner will enter an order on this data, making findings and conclusions on such data".11 After the regulation had been legally promulgated, which was more than a year after the appellant had requested a hearing, the Commissioner directed the appellant's attention to these new regulations and suggested that it...

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7 practice notes
  • Weinberger v. Hynson, Westcott and Dunning, Incorporated Hynson, Westcott and Dunning, Incorporated v. Weinberger 8212 394, 72 8212 414, Nos. 72
    • United States
    • United States Supreme Court
    • June 18, 1973
    ...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. Opening statement by Daniel M. Friedman, Washington, D.C., for Caspar W. Weinberger, Secretary, HEW, in all five cases. A......
  • U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., No. 82-1381
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • February 27, 1984
    ...the idea, not of a preponderance, but rather of a responsible body of qualified opinion." Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215, 220 (4th Cir.1972), aff'd sub nom. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973) (foot......
  • Agri-Tech, Inc. v. Richardson, No. 72-1252.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (8th Circuit)
    • August 2, 1973
    ...(3rd Cir. 1972) ; USV Pharmaceutical Corp. v. Richardson, 461 F.2d 223 (4th Cir. 1972) ; Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215 (4th Cir. 1972). Directly involved in those cases were the issues posed here. We therefore concluded to withhold our decision until opinions ......
  • United States v. Prudential Insurance Co. of America, No. 71-2110 Summary Calendar.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • July 18, 1972
    ...and those having only prospective effect—it is almost inconceivable to suggest that here the Government has exercised a nonexistent right 461 F.2d 215 and levied against a nonexistent obligation. Since the service of the notice of levy amounted to an exercise of the taxpayer's right to paym......
  • Request a trial to view additional results
7 cases
  • Weinberger v. Hynson, Westcott and Dunning, Incorporated Hynson, Westcott and Dunning, Incorporated v. Weinberger 8212 394, 72 8212 414, Nos. 72
    • United States
    • United States Supreme Court
    • June 18, 1973
    ...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. Opening statement by Daniel M. Friedman, Washington, D.C., for Caspar W. Weinberger, Secretary, HEW, in all five cases. A......
  • U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., No. 82-1381
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • February 27, 1984
    ...the idea, not of a preponderance, but rather of a responsible body of qualified opinion." Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215, 220 (4th Cir.1972), aff'd sub nom. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973) (foot......
  • Agri-Tech, Inc. v. Richardson, No. 72-1252.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (8th Circuit)
    • August 2, 1973
    ...(3rd Cir. 1972) ; USV Pharmaceutical Corp. v. Richardson, 461 F.2d 223 (4th Cir. 1972) ; Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215 (4th Cir. 1972). Directly involved in those cases were the issues posed here. We therefore concluded to withhold our decision until opinions ......
  • United States v. Prudential Insurance Co. of America, No. 71-2110 Summary Calendar.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • July 18, 1972
    ...and those having only prospective effect—it is almost inconceivable to suggest that here the Government has exercised a nonexistent right 461 F.2d 215 and levied against a nonexistent obligation. Since the service of the notice of levy amounted to an exercise of the taxpayer's right to paym......
  • Request a trial to view additional results

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