Court Opinion

ID: 9425354
Source: CourtListenerOpinion
Date Created: 2023-08-02 23:14:28.767593+00
Date Added: 2024-06-11T17:22:55.071163
License: Public Domain

Mr. Justice Powell,
concurring in part, and concurring in the result in part.
I concur in Part II of the Court’s opinion, which disposes of the issues raised by Hynson, Westcott & Dunning, Inc., in its cross-petition (No. 72-414). As to Part I, which addresses issues raised in the petition filed by the Commissioner of FDA (No. 72-394), I concur only in the result and state briefly the limited sense in which I accept the Court’s conclusion.
Insofar as the Court today sustains the holding below that Hynson’s submission to FDA raised “a genuine and *638substantial issue of fact” requiring a hearing on the ultimate issue of efficacy, 21 CFR § 130.14 (b), I am in accord. Hynson’s presentation in support of the efficacy of Lutrexin clearly justified a hearing as to whether the drug was supported by “adequate and well-controlled investigations,” 21 U. S. C. § 355 (d), even as that term is defined in the Commission’s regulations. 21 CFR §130.12 (a)(5). For this reason I concur in the result reached in this case. I cannot agree on this record, however, with any implications or conclusions in the Court’s opinion to the effect that the regulations— as construed and applied by the Commissioner in this case — are either compatible with the statutory scheme or constitutional under the Due Process Clause.1 Such questions have not been squarely presented here and, in light of the Court’s conclusion that Hynson has complied with the regulations, their resolution is unnecessary to the Court’s decision.
Were we required to reach these issues, there might well be serious doubt whether the Commissioner’s rigorous threshold specifications as to proof of “adequate and well-controlled investigations,” coupled with his restrictive summary judgment regulation, go beyond the statutory requirements and in effect frustrate the congressional mandate for a prewithdrawal “opportunity for hearing.” 21 U. S. C. § 355 (e). There is also a genuine issue of procedural due process where, as in this case, the Commissioner construes his regulations to deny a hearing as to the efficacy of a drug established and used by the medical profession for two decades, and where its effec*639tiveness is supported by a significant volume of clinical data and the informed opinions of experts whose qualifications are not questioned.2
These important and complex questions should await decision in future cases in which the issues are briefed fully and are necessary to the Court’s decision.

 There can be no doubt, both from the legislative history and the language of the 1962 amendments to the Act, that Congress intended to impose standards that would bar reliance upon anecdotal evidence or mere professions of belief by doctors as determinative of a drug’s efficacy. But it is also clear that Congress intended to protect against the arbitrary withdrawal or withholding of approval of a drug where there is “substantial evidence” of its effectiveness. To provide protection against such action, especially when authority is vested in an official who acts in an administrative as well as judicial capacity, the Act specifically provides for a hearing. The public interest is twofold: (i) to remove from the market, in accordance with due process, drags of no utility or effectiveness; and (ii) to retain on the market those drugs that are efficacious. In an understandable zeal to remove the former, an administrative agency must not overlook both the interest of the public and the right of the proprietor in protecting the drags that are useful in the prevention, control, or treatment of illness.