Court Opinion

ID: 8896106
Source: CourtListenerOpinion
Date Created: 2022-11-27 00:02:02.987855+00
Date Added: 2024-06-11T17:07:29.887159
License: Public Domain

LUMBARD, Circuit Judge
(concurring):
I am not as confident as my brothers that Congress intended the FDA to have substantive rule-making authority with respect to the prescription status of drugs. However, in light of the bare statutory language of section 701(a), 21 U.S.C. § 371(a), the lack of clear legisla*705tive history denying such power to the FDA, and recent judicial trends, see, e. g., Mourning v. Family Publication Services, Inc., 411 U.S. 356, 93 S.Ct. 1652, 36 L.Ed.2d 318 (1973); National Petroleum Refiners Assn. v. FTC, 157 U.S.App.D.C. 83, 482 F.2d 672 (1973), cert. denied, 415 U.S. 951, 94 S.Ct. 1475, 39 L.Ed.2d 567 (1974), there seems little doubt that these regulations would be upheld by the Supreme Court.
What motivates this brief concurring statement is my concern that substantive agency action receive adequate review in the courts. What Congress intended in 1938, when the FDA was created, is less than clear with respect to the exercise of substantive rule-making powers under such a provision as section 701(a). However, in light of the fact that the FDA did not choose to exercise such power for so many years after it was supposedly granted, it would be less than realistic to think that Congress gave such rule-making much thought when it passed the Administrative Procedure Act in 1946.1 Consequently, the quality and nature of judicial review of such rule-making as occurred here is open to some speculation.
As Judge Mansfield points out, the Administrative Procedure Act provides that the proper scope of review here is whether the agency action was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). This is so despite the fact that Congress provided a different form of review — one which required the FDA’s actions to be based on substantial evidence — when it specifically authorized the FDA to engage in substantive rule-making. See 21 U.S.C. § 371(e), (f).
Courts have chosen to uphold ever more generously and liberally the exercise of substantive rule-making powers by administrative agencies. Consequently it seems to me only appropriate that when courts approve such broader powers, they give due consideration to whether analogous changes may be needed in judicial interpretation of the Administrative Procedure Act. In cases such as this, where an agency engages in substantive rule-making under the authority of a general rule-making authorization, the courts should interpret the phrase “arbitrary, capricious, [or] an abuse of discretion” so as to ensure that real judicial review of agency action is provided. A district judge should carefully examine the information that was before the agency to see if it gives adequate and substantive support to the agency’s position.2 While a court should not substitute its views for those of the agency, it should not think that the “arbitrary [or] capricious” standard is so loose that it must approve anything that an agency does so long as the agency’s actions are not completely irrational. Indeed, in the area of substantive rule-making a court should not hesitate to overturn an agency’s action if it is not fairly supported by the evidence before the agency. In essence I think that when an agency engages in substantive rule-making, it abuses its discretion (or acts arbitrarily or capriciously) if its actions are not supported by substantial evidence. Cf. 5 U.S.C. § 706(2)(E).
Although Judge Frankel applied the traditional “arbitrary [or] capricious” standard of review in this case, an examination of the language of his two opinions on these regulations suggests to me that he did conduct a review similar to what I espouse here. Indeed, at one point he states that he probably would have reached the same conclusion as the FDA did on a particular issue if he had initially been called to rule on it.
For these reasons, I concur.

. Another example of an agency recently deciding that a long-standing statute authorized the issuance of substantive rules is provided by National Petroleum Refiners Assn. v. FTC, supra.

. Section 4 of the Administrative Procedure Act, 5 U.S.C. § 553, requires that an agency give “a concise general statement of [the] basis and purpose” of rules that it adopts. As Judge Mansfield notes, an agency has an obligation to publish a statement of reasons that is sufficiently detailed to permit judicial review. Opinion at 701.