Sterling Drug, Inc. v. Weinberger
| Decision Date | 09 October 1974 |
| Docket Number | D,Nos. 623,624,s. 623 |
| Citation | 503 F.2d 675 |
| Parties | STERLING DRUG INC. et al., Petitioners, v. Caspar W. WEINBERGER, Secretary of Health, Education and Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Respondents. ockets 73-1628, 73-2481. |
| Court | U.S. Court of Appeals — Second Circuit |
William F. Weigel, New York City (James B. Swire, E. Carrington Boggan, Rogers, Hoge and Hills, New York City; James H. Luther, Jr., Roger M. Rodwin, of counsel), for Sterling Drug Inc.
Robert V. Allen, Dept. of Justice, Washington, D.C. (Howard S. Epstein, Asst. Chief, Consumer Affairs Section, Dept. of Justice, on the brief), for respondents.
Before MULLIGAN and WATERMAN, Circuit Judges, and BRYAN, District judge. *
FREDERICK van PELT BRYAN, District Judge:
In these consolidated appeals, Sterling Drug Inc. and its subsidiaries Winthrop Products, Inc. and Breon Laboratories, Inc. petition to set aside two orders of the Commissioner of Food and Drugs, dated March 2, 1973 and August 7, 1973. 1 The orders, issued under the 1962 amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., denied petitioners' requests for a hearing and withdrew prior approval of new drug applications for petitioners' product, Alevaire, alleging lack of substantial evidence that the drug was effective for its recommended uses.
Alevaire is an aerosol prescription drug administered to patients with chronic respiratory diseases, to aid in the evacuation of mucous from the lungs. Alevaire is a solution of 0.125% Tyloxapol, 2% Sodium bicarbonate, 5% Glycerine, and 92.875% Water. Tyloxapol is described as the 'active' mucoevacuant agent, while glycerine is a 'stabilizer' and sodium bicarbonate acts to adjust the 'pH factor' (alkalinity and acidity) in the lungs.
Under the Federal Food, Drug and Cosmetic Act of 1938, no drug may be introduced into interstate commerce unless a New Drug Application (NDA), filed with the Food and Drug Administration (FDA), is in effect. The Act established procedures under which, after notice and hearing, the FDA could refuse to permit an NDA to go into effect or withdraw prior approval on the basis of evidence that the drug was unsafe for its intended use.
In 1962, the 1938 Act was amended to provide that the FDA could disapprove or withdraw prior approval of NDA's, not only on evidence that the drug was unsafe for intended use but also if substantial evidence is lacking that the drug is effective for its intended use. Substantially the same requirements for notice and hearing are provided.
Pursuant to the Act, as amended, the FDA undertook the review of marketed drugs, including those for which NDA's were in effect, for their therapeutic effectiveness. To aid it in this task, the FDA retained the National Academy of Sciences-National Research Council (NAS-NRC) to review the effectiveness for intended use of each approved drug.
NDA's for Alevaire had been approved by the FDA in 1952, when only the safety factor was controlling. On July 17, 1968 the FDA notified petitioners that the NAS-NRC had reported that it rated Alevaire as 'ineffective' and that the FDA concurred in that conclusion. 2 Petitioners were advised that the FDA intended to institute proceedings to withdraw the approval previously given to petitioners' NDA's for Alevaire.
Pursuant to 21 U.S.C. 355(e), 3 formal 'Notice of Opportunity for Hearing' was given to petitioners on December 1, 1969. The notice, after reference to the NAS-NRC report, advised petitioners that the FDA proposed to issue an order withdrawing approval of the NDA's for Alevaire 'on the grounds that there is a lack of substantial evidence that Alevaire has the effect which it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof.' It further advised petitioners of their right to avail themselves of an opportunity for a hearing and to submit clinical and investigational data to show they were entitled to a hearing.
Under the FDA regulations, 21 C.F.R. 130.14(b), 4 a hearing can be denied only if the petitioners fail to submit at least some evidence of the drug's effectiveness stemming from adequate and well-controlled clinical investigations 21 C.F.R. 130.12(a)(5)(ii). 5 Petitioners duly submitted a written appearance requesting a hearing pursuant to 21 C.F.R. 130.14(b) together with a mass of evidence in support of the effectiveness of Alevaire. Petitioners' submissions as to the effectiveness of Alevaire, in addition to contentions that the NAS-NRC report was mistaken in major respects, relied principally on two clinical studies made by physicians whose qualifications in this field were never questioned. These studies were primarily directed at the basic criticism in the NAS-NRC report that 'This product is no more effective than water'. The first clinical study, by Doctors Miller and Paez (the Miller-Paez Study) concluded that Alevaire was effective as a mucoevacuant and superior to both water and saline. The other, by Dr. Cohen (the Cohen Study) compared Alevaire with water and concluded that Alevaire was a superior and effective muco-evacuant.
These studies were supported by affidavits from 10 physicians, knowledgeable and experienced in the field, that the Miller-Paez and Cohen Studies were 'adequate and well-controlled' within the FDA requirements and established the effectiveness of Alevaire as a muco-evacuant.
In addition, petitioners submitted affidavits from six physicians based on their own extensive clinical experience with Alevaire to the effect that the drug was effective, and more effective than the commonly used agents of water and saline, and summaries of some 150 articles in medical and scientific literature commenting favorably on Alevaire and its use as a muco-evacuant.
On August 27, 1971, the FDA issued an order denying the petitioners' request for a hearing and withdrawing approval of petitioners' NDA's for Alevaire, primarily on the ground that the Miller-Paez and Cohen clinical studies were 'not adequate and well-controlled'.
The petitioners thereupon filed an appeal from the order in this Court (Docket No. 71-1898) and filed their printed briefs and appendix. At that point the FDA terminated its August 27, 1971 order and moved in this Court to remand, conceding that it had failed to consider relevant material in petitioners' submissions. It agreed to reconsider petitioners' request for a hearing. The FDA's motion to remand was granted by this Court over petitioners' opposition on January 11, 1972.
A series of conferences and communications between the petitioners and the FDA ensued. On March 2, 1973, some 14 months after the petition to remand the first appeal had been granted, the FDA issued a second order again denying petitioners a hearing and withdrawing approval of the NDA's for Alevaire.
Denial of the hearing was again based upon the ground that the Miller-Paez and Cohen studies were not adequate and well-controlled under the standards of 21 C.F.R. 130.12(a)(5)(ii). For the first time, the criticism was also voiced that water was not a proper 'control' with which to compare Alevaire, but that the proper 'control' was Alevaire minus tyloxapol. 6
On April 16, 1973, the petitioners requested the FDA to reconsider its March 2 order. They submitted to the FDA an extensive rebuttal of the grounds on which the order was based, 7 which, in the light of subsequent events, was apparently well taken.
The petitioners also appealed to this Court seeking to set side the March 2, 1973 order (Docket No. 73-1628). On June 14, 1973, when its time to file the record was about to expire, the FDA terminated its March 2 order and reinstated its approval of the NDA's for Alevaire. The order of termination stated that upon reviewing the petition for reconsideration, the FDA had concluded that the requests for a hearing should be reevaluated. The FDA also moved to dismiss the pending appeal from the March 2 order. The petitioners opposed that motion, asserting they were entitled to a decision in their favor on the merits.
Then, on August 7, 1973, before the FDA's motion to dismiss the appeal from the March 2, 1973 order was argued, the FDA issued a third order denying a hearing and withdrawing approval of the petitioners' NDA's for Alevaire. This third order abandoned the grounds on which the prior two orders of March 2, 1973 and August 27, 1971 had been based. It advanced an apparently new ground for withdrawal which had never been previously raised. The ground now announced was that Alevaire was a 'fixed combination' drug and that the only studies which could demonstrate its effectiveness were studies which assessed 'the contribution each of the three components of Alevaire makes to the claimed effectiveness of the drug'. The Miller-Paez and Cohen Studies were rejected as irrelevant to this theory.
Petitioners appealed to this Court seeking to set aside the third order of August 7, 1973 (Docket No. 73-2481). The FDA's motion to dismiss petitioners' appeal from the March 2, 1973 order was denied on November 9, 1973, and the appeal from that order was consolidated with the appeal from the subsequent August 7, 1973 order.
The appeal from the March 2, 1973 order denying a hearing and withdrawing approval of the Alevaire NDA's is in a curious posture. Subsequent to the taking of the appeal, the March 2 order was terminated by the FDA's order of June 14, 1973 which granted petitioners' application for reconsideration of their requests for a hearing and reinstated approval of the Alevaire NDA's.
The respondents' brief states: ...
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