Monday, July 23, 2012

One More Thing From the Memorandum in Support of FDA's Motion to Dismiss in K-V Pharma Lawsuit ($KV)

Plaintiffs’ requests that this Court supervise FDA’s enforcement activities are extraordinary and improper because, as discussed below (pp 18-21), FDA’s non-enforcement decisions are committed to the agency’s discretion. See Heckler v. Chaney, 470 U.S. 831, 837-38; Judicial Watch, 2012 U.S. Dist. LEXIS 26684 *39 (where court could not order relief plaintiff sought because the “enforcement tools provided to the defendant under [the statute] are committed to the agency’s sole discretion,” plaintiff lacked standing); see Block v. SEC, 50 F.3d 1078, 1084 (D.C. Cir. 1995) (“the agency alone, and neither a private party nor a court, is charged with the allocation of enforcement resources.”); Coker v. Sullivan, 902 F.2d 84, 89 (D.C. Cir. 1990) (“This court should not steer the Department’s resources and shape its priorities when we lack knowledge of the matters competing for the Department’s attention.”); see also Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 64 (2004) (under 5 U.S.C. § 706(1), court can only compel agency to take “a discrete agency action that it is required to take”).

Plaintiffs are, in effect, asking the Court to assume the role of FDA’s “director of enforcement,” a task for which it is ill-suited. Chaney, 470 U.S. at 831-32 (“The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.”). To meet Plaintiffs’ demands, the Court must order FDA to disregard not only its own risk-based approach for prioritizing inspection and enforcement resources regarding compounding generally but also, consequently, its priorities for other unrelated enforcement activities: more time spent on pharmacies compounding 17-HPC means less time spent pursuing enforcement actions in other areas. Sierra Club v. Whitman, 268 F.3d 898, 903 (9th Cir. 2001) (EPA “must be able to choose which violations are most egregious. It would be unwise for the judiciary . . . to attempt to set the priorities for the EPA’s enforcement decisions.”).

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