respondents' argument that the Act's substantive prohibitions of "misbranding" and the introduction of "new drugs" absent agency approval, see 21 U. S. C. §§ 352(f)(1), 355, supply us with "law to apply." These provisions are simply irrelevant to the agency's discretion to refuse to initiate proceedings.
We also find singularly unhelpful the agency "policy statement" on which the Court of Appeals placed great reliance. We would have difficulty with this statement's vague language even if it were a properly adopted agency rule. Although the statement indicates that the agency considered itself "obligated" to take certain investigative actions, that language did not arise in the course of discussing the agency's discretion to exercise its enforcement power, but rather in the context of describing agency policy with respect to unapproved uses of approved drugs by physicians. In addition, if read to circumscribe agency enforcement discretion, the statement conflicts with the agency rule on judicial review, 21 CFR § 10.45(d)(2) (1984), which states that "[t]he Commissioner shall object to judicial review ... if (i) [t]he matter is committed by law to the discretion of the Commissioner, e. g., a decision to recommend or not to recommend civil or criminal enforcement action ...." But in any event the policy statement was attached to a rule that was never adopted. Whatever force such a statement might have, and leaving to one side the problem of whether an agency's rules might under certain circumstances provide courts with adequate guidelines for informed judicial review of decisions not to enforce, we do not think the language of the agency's "policy statement" can plausibly be read to override the agency's express assertion of unreviewable discretion contained in the above rule.[1]
- ↑ Respondents also urge, as did the Court of Appeals, that a statement by the FDA's lawyers in a footnote to to their "memorandum in support of dismissal" in the District Court indicates that the agency considers the "policy statement" "binding." The footnote said that the "Federal Regis-
