(b) The presumption that agency decisions not to institute enforcement proceedings are unreviewable under § 701(a)(2) is not overcome by the enforcement provisions of the FDCA. Those provisions commit complete discretion to the Secretary to decide how and when they should be exercised. The FDCA's prohibition of "misbranding" of drugs and introduction of "new drugs," absent agency approval, does not supply this Court with "law to apply." Nor can the FDA's "policy statement" indicating that the agency considered itself "obligated" to take certain investigative actions, be plausibly read to override the agency's rule expressly stating that the FDA Commissioner shall object to judicial review of a decision to recommend or not to recommend civil or criminal enforcement action. And the section of the FDCA providing that the Secretary need not report for prosecution minor violations of the Act does not give rise to the negative implication that the Secretary is required to investigate purported "major" violations of the Act. Pp. 835–837.
231 U. S. App. D. C. 136, 718 F. 2d 1174, reversed.
Rehnquist, J., delivered the opinion of the Court, in which Burger, C. J., and Brennan, White, Blackmun, Powell, Stevens, and O'Connor, JJ., joined. Brennan, J., filed a concurring opinion, post, p. 838. Marshall, J., filed an opinion concurring in the judgment, post, p. 840.Deputy Solicitor General Geller argued the cause for petitioner. With him on the briefs were Solicitor General Lee, Acting Assistant Attorney General Willard, Samuel A. Alito, Jr., Leonard Schaitman, John M. Rogers, Thomas Scarlett, and Michael P. Peskoe.
Steven M. Kristovich argued the cause for respondents. With him on the brief were David E. Kendall, Julius LeVonne Chambers, James M. Nabrit III, John Charles Boger, James S. Liebman, and Anthony G. Amsterdam.[1]
- ↑ A brief of amicus curiae urging reversal was filed for the Washington Legal Foundation by Daniel J. Popeo, Paul D. Kamenar, George C. Smith, and Stephen Weitzman.
Briefs of amici curiae urging affirmance were filed for the American Society of Law and Medicine et al. by James M. Doyle; and for the Public Citizen by Alan B. Morrison and William B. Schultz.
