Opinion ID: 7267
Heading Depth: 3
Heading Rank: 3

Heading: Degree of Enforcement Discretion Accorded FDA

Text: 60 Even if CPG 7132.16 does not create binding norms, argues P2C2, the rule so narrowly constricts FDA enforcement discretion that the CPG should be deemed to be a substantive rule. 43 P2C2 contends that CPG 7132.16 acts essentially to identify those pharmacies against which the FDA will bring enforcement actions, thereby denying the agency any semblance of discretion. We disagree. 61 True, the FDA had even greater discretion in bringing enforcement actions before CPG 7132.16 issued; prior to that time inspectors were apparently provided with no official guidance whatsoever. In that sense, therefore, CPG 7132.16 has channeled the FDA's enforcement discretion, providing direction--where once there was none--by helping to determine whether a pharmacy is engaged in traditional compounding or drug manufacturing. But all statements of policy channel discretion to some degree--indeed, that is their purpose. The more cogent question therefore is whether CPG 7132.16 is so restrictive in defining which pharmacies are engaged in drug manufacturing that it effectively removes most, if not all, of the FDA's discretion in deciding against which pharmacies it will bring an enforcement action. We cannot read CPG 7132.16 that restrictively. 62 CPG 7132.16 makes clear that it was not intended to foreclose the agency's exercise of its discretion in bringing an enforcement action. In fact, the rule expressly refers to the discretionary nature of bringing such actions: 63 [T]he agency may, in the exercise of its enforcement discretion, initiate federal enforcement actions ... when the scope and nature of a pharmacy's activity raises the kinds of concerns normally associated with a manufacturer and that results in significant violations of the new drug, adulteration, or misbranding provisions of the Act. 44 64 The D.C. Circuit has in some cases given decisive weight to the agency's choice between the words 'may' and 'will,'  45 but we need not go so far today. 65 We further observe that the language of CPG 7132.16 that purports to distinguish traditional compounding from drug manufacturing is imprecise and discretionary--not exact and certain. The rule, for example, states what action the FDA may take in its discretion to address significant violations; it does not mandate a particular agency response once precisely fixed thresholds are exceeded. 46 CPG 7132.16 also expresses that the list of nine factors is neither dispositive nor exhaustive. Although CPG 7132.16 may assist the FDA in identifying pharmacies engaged in the manufacture of drugs, it clearly leaves to the sound discretion of the agency in each case the ultimate decision whether to bring an enforcement action. 66 Undaunted, P2C2 argues that CPG 7132.16 is analogous to the parole board rules (the Rules) held to be substantive in Pickus v. United States Board of Parole. 47 But that analogy fails when we recognize that the Rules considered in Pickus are quite different from the nine factors of the instant case. The Rules in Pickus, which purported to provide guidance whether a prisoner was entitled to parole, were divided into nine general categories and then further subdivided into thirty-two subcategories, going into exacting detail as to how the Board was to determine whether an applicant was entitled to parole. Because the Rules were so minutely detailed, reasoned the D.C. Circuit, they narrowed [the decisionmaker's] field of vision, minimizing the influence of other factors. As such, the court concluded that the Rules were substantive and therefore subject to APA notice-and-comment. Compared to the Rules in Pickus, however, the nine factors listed in CPG 7132.16 are broad, general, elastic, and far less inclusive. As a result, they do not have the same restrictive effect on agency decisionmakers as do the Rules. 67 In sum, nowhere does CPG 7132.16 draw a line in the sand that, once crossed, removes all discretion from the agency. We cannot agree with P2C2, therefore, that CPG 7132.16 so significantly restricts the discretionary role of the FDA in determining whether to bring an enforcement action against a pharmacy as to transform it into a substantive rule. In our view, CPG 7132.16 merely identifies some indicia of drug manufacturing; it neither compels the conclusion that a pharmacy is engaged in drug manufacturing nor provokes an automatic or nondiscretionary response from the agency. Rather, FDA inspectors are free to consider in toto those nine factors, as well as others, and then, based on that guidance and their own judgment, decide whether the pharmacy in question is engaged in drug manufacturing. Such is the nature of a discretionary rule, not of a substantive one. 68