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Hill Dermaceuticals, Inc. v. U.S. Food & Drug Administration

November 29, 2007


The opinion of the court was delivered by: United States District Judge Royce C. Lamberth


Now before the court comes plaintiff, Hill Dermaceuticals, Inc's ("HDI's") motion [4] for a stay to prevent the approval of any generic versions of HDI's Derma-Smoothe/FS(r) (flucinolone acetonide) Scalp Oil or Body Oil ("Derma-Smoothe") until the Food and Drug Administration ("FDA") provides a substantive response to HDI's citizen petition. Upon full consideration of the motion, defendants' opposition, the reply, the entire record herein, and applicable law, this Court finds that plaintiff's motion will be DENIED.


Plaintiff HDI manufactures and distributes the drug Derma-Smoothe. On September 30, 2004, HDI submitted a citizen petition*fn1 to the FDA requesting that it require any potential manufacturer of a generic version of Derma-Smoothe to follow specific clinical procedures in proving the generic version's bioequivalence*fn2 to Derma-Smoothe. Particularly, HDI requested that the FDA require any generic manufacturer to, in its Abbreviated New Drug Application ("ANDA"),*fn3 demonstrate bioequivalence only through studies using clinical endpoints rather than through the more typically required studies that employ skin blanching equivalence tests. (See Mot. to Stay at 9.)

On March 24, 2005, the FDA responded to HDI's citizen petition by letter stating: "FDA has been unable to reach a decision on your petition because of the need to address other Agency priorities. This interim response is provided in accordance with FDA regulations on citizen petitions (21 C.F.R. § 10.30(e)(2)). We will respond to your petition as soon as possible given the numerous demands on the Agency's resources." (Ltr. to Roth, Ex. C to Compl.) (hereinafter "Tentative Response") HDI asserts that the FDA's Tentative Response is inadequate according to the text of 21 C.F.R. § 10.30(e). Citing this inadequacy, HDI states that the FDA violated the Administrative Procedure Act ("APA") and has endangered public safety. (See Mot. to Stay at 1--2.) HDI thus requests that this Court issue a stay preventing FDA approval of any generic version of Derma-Smoothe until it receives a "substantive" response to its citizen petition. (See Id. at 1.) Defendants claim that they have complied with all applicable statutes and regulations and that a stay is consequently improper. (See Def.'s Opp. at 10--11.)



1. Legal Standard for Stay

The four-factor standard used by courts for a motion to stay agency action is the same legal standard as that used in a motion for preliminary injunction. Compare Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1066 (D.C. Cir. 1998) (applying four-factor standard in a preliminary injunction case), with Cuomo v. U.S. Nuclear Regulatory Comm'n, 772 F.2d 972, 974 (D.C. Cir. 1985) (per curiam) (applying same standard in a motion to stay).

The factors to be considered in determining whether a stay is warranted are: (1) the likelihood that the party seeking the stay will prevail on the merits of the appeal; (2) the likelihood that the moving party will be irreparably harmed absent a stay; (3) the prospect that others will be harmed if the court grants the stay; and (4) the public interest in granting the stay.

Cuomo, 772 F.2d at 974 (citing WMATC v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C. Cir. 1977); see Va. Petroleum Jobbers Ass'n v. Fed. Power Comm'n, 259 F.2d 921, 925 (D.C. Cir. 1958) (explaining the four factors). No one factor is determinative and the Court should balance a movant's showings regarding the four factors on a sliding scale. See Shalala, 140 F.3d at 1066; CityFed Fin. Corp. v. Office of Thrift Supervision, 58 F.3d 738, 747 (D.C. Cir. 1995) ("If the arguments for one factor are particularly strong, an injunction may issue even if the arguments in other areas are rather weak."). Granting a motion to stay-like granting injunctive relief-is an "extraordinary remedy" and it is the movant's obligation to justify the court's use of such a measure. Cuomo, 772 F.2d at 978; see Mazurek v. Armstrong, 520 U.S. 968, 972 (1997) (stating that a "preliminary injunction is an extraordinary and drastic remedy, one that should not be granted unless the movant, by a clear showing, carries the burden of persuasion").

2. Legal Standard for Review of FDA Actions

"The APA entitles 'a person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action . . . to judicial review thereof.'" Biovail Corp. v. U.S. Food and Drug Admin., 448 F. Supp. 2d 154, 160 (D.D.C. 2006) (quoting 5 U.S.C. § 702). Specifically, the APA requires that agencies decide matters "within a reasonable time." 5 U.S.C. § 555(b). And, courts are required to "compel agency action that is unlawfully withheld or unreasonably delayed." 5 U.S.C. § 706(1); see Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 63 (2004) (noting that under the APA, courts can only compel agencies to take actions that they are "legally required to take"); Pub. Citizen Health Research Group v. Comm'r, Food & ...

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