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

December 2, 2011


The opinion of the court was delivered by: Signed by Royce C. Lamberth, Chief Judge,


Plaintiff Hill Dermaceuticals, Inc. ("Hill") has brought this action against the U.S. Food and Drug Administration ("FDA"), the U.S. Department of Health and Human Services ("HHS"), Kathleen Sebelius, in her official capacity as Secretary of HHS, and Margaret Hamburg, M.D., in her official capacity of Commissioner of FDA. Amneal Pharmaceuticals, LLC ("Amneal") has intervened as a defendant. Hill manufactures fluocinolone acetonide topical oil products under the brand names Derma-Smoothe/FS (Body Oil and Scalp Oil) and Derm-Otic Oil Ear Drops. On October 17, 2011, the FDA approved requests by Identi Pharms, Inc. ("Identi") to market purported generic versions of these fluocinolone acetonide products. Hill seeks to enjoin the FDA to withdraw or suspend its approval of the three abbreviated new drug applications ("ANDAs") submitted by Identi on the basis that the approval contravenes the sameness requirements, the misbranding restrictions, and the bioequivalence requirements of the Food, Drug, and Cosmetic Act and its implementing regulations. 21 U.S.C. §§ 355(j)(2)(A)(v), 355(j)(2)(A)(iv), 352(a); 21 C.F.R. §§ 314.94(a)(8)(iv), 320.1, 320.22(b). Hill also claims that FDA's approval of Identi's three ANDAs constitutes arbitrary and capricious agency action in violation of the Administrative Procedure Act. 5 U.S.C. § 706.

Before the Court is plaintiff's Motion [3] for a preliminary injunction. Upon consideration of plaintiff's Motion, Federal defendants' opposition [25], intervenor defendant's opposition [40], plaintiff's reply [27], Federal defendants' surreply [42], the arguments made in open court on November 29, 2011, the entire record in this case, and the applicable law, the Court will DENY plaintiff's Motion [3] for a preliminary injunction. The Court will explain its reasoning in the analysis that follows.


A.Statutory and Regulatory Framework

1.New Drug Applications and Abbreviated New Drug Applications

Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., pharmaceutical companies seeking to market "pioneer" or "innovator" drugs must first obtain FDA approval by filing a new drug application ("NDA"). 21 U.S.C. § 335(a), (b). The NDA must contain extensive scientific data and other information, including investigative reports demonstrating the drug's safety and effectiveness, a statement of the drug's components, and specimens of proposed labeling for the packaging of the drug. 21 U.S.C. § 335(b)(1).

The Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Amendments"), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282, permits the submission of abbreviated new drug applications ("ANDAs") for approval of generic versions of drug products with approved NDAs. 21 U.S.C. § 355(j). The Hatch-Waxman Amendments were intended to balance encouraging innovation in drug development with accelerating the availability of lower cost generic alternatives to innovator drugs. See H.R. Rep. No. 98-857 (Part I), 98th Cong., 2d Sess. at 14--15 (1984), reprinted in 1984 U.S.C.C.A.N. 2547--48; see also Tri-Bio Labs., Inc. v. United States, 836 F.2d 135, 139 (3d Cir. 1987).

2.ANDA Approval Requirements

To obtain approval, ANDA applicants are not required to submit clinical evidence to establish the safety and effectiveness of the generic drug product. Rather, an ANDA references an approved drug-the reference listed drug ("RLD")-and relies on FDA's previous finding that the RLD is safe and effective. Additionally, an ANDA applicant must provide sufficient information to show that the generic drug product has the same active ingredient or ingredients, dosage form, route of administration, and strength as the RLD. 21 U.S.C. § 355(j)(2)(A)(ii), (iii). An ANDA application must also demonstrate that its product is bioequivalent to the RLD and has the same labeling as the RLD. 21 U.S.C. §§ 355(j)(2)(A)(iv), (v). The agency must approve an ANDA unless it finds, among other things, that the ANDA has not provided sufficient evidence of the foregoing. 21 U.S.C. § 355(j)(4).

The FDCA requires that an ANDA contain "information to show that the labeling proposed for the new [generic] drug is the same as the labeling approved for the listed drug . . . except for changes required because of differences approved under a petition filed under [21 U.S.C. § 355(j)(2)(C)] or because the new drug and the listed drug are produced or distributed by different manufacturers." 21 U.S.C. § 355(j)(2)(A)(v). Permissible labeling differences include "differences in expiration date, formulation, bioavailability, . . . [or] labeling revisions made to comply with current FDA labeling guidelines or other guidance." 21 C.F.R. § 314.94(a)(8)(iv).

The FDCA also requires an ANDA to include information showing that the generic drug product is bioequivalent to the pioneer drug product. 21 U.S.C. §§ 355(j)(2)(A)(iv), (j)(4)(F); 21 C.F.R. §§ 314.127(a)(6)(i), 314.94(a)(7). A drug is considered to be bioequivalent if "the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug." 21 U.S.C. § 355(j)(8)(B)(i). FDA regulations further define bioequivalence as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." 21 C.F.R. § 320.1(e). The FDA will grant a bioequivalence waiver-that is, the FDA will not require the submission of evidence obtained in vivo measuring bioequivalence of the two products-if the generic drug product: (1) "is a solution for application to the skin, an oral solution, elixir, syrup, tincture, a solution for aerosolization or nebulization, a nasal solution, or similar other solubilized form"; (2) "contains an active drug ingredient in the same concentration and dosage form as a drug product that is the subject of an approved full new drug application or abbreviated new drug application"; and (3) "contains no inactive ingredient or other change in formulation from the drug product . . . that may significantly affect absorption of the active drug ingredient." 21 C.F.R. § 320.22(b)(3)(i)-- (iii).

Furthermore, each ANDA must include "the specifications necessary to ensure the identity, strength, quality, and purity of the drug substance . . . including, for example, tests [and] analytical procedures." 21 C.F.R. § 314.50(d)(1); 21 C.F.R. § 314.94(a)(9)(i). An applicant must submit copies of analytical procedures and related descriptive information "that are necessary for FDA's laboratories to perform all necessary tests on the samples and to validate the applicant's analytical procedures," including "a detailed description of the methods of analysis [and] supporting data for accuracy, specificity, precision and ruggedness." 21 C.F.R. § 314.50(e)(2)(i). FDA's regulations include provisions to ensure the accuracy, reliability, suitability, and reproducibility of an applicant's test methods. See 21 C.F.R. §§ 211.165(e), 211.194(a)(2).

B.Factual Background

1.Hill's Fluocinolone Acetonoide Products

FDA first approved Hill's NDA for Derma-Smoothe (fluocinolone acetonide 0.01% topical oil) on February 3, 1988. Hill's NDA includes Body Oil, Scalp Oil, and Oil Ear Drops, even though they are separate products. Derma-Smoothe Body Oil is indicated to topically treat atopic dermatitis for adult patients and some pediatric patients with moderate to severe atopic dermatitis. Derma-Smoothe Scalp Oil is indicated to treat scalp psoriasis on adult patients. DermOtic Oil Ear Drops are indicated to treat chronic eczematous external otitis in adults and pediatric patients two years of age and older. These products are intended for local, topical use and are not intended to be systemically absorbed. FDA has designated Derma-Smoothe as the RLDs for generic fluocinolone acetonide topical oil products.

Hill's Derma-Smoothe products include peanut oil that has been refined in accordance with the United States Pharmacopeia-National Formulary ("USP-NF") standard. When Hill submitted a supplement to its NDA in 1998, FDA requested that Hill improve its testing of the Derma-Smoothe product because the then-current USP-NF monograph for peanut oil did not include enough information to ensure that the peanut oil would be sufficiently free of peanut protein. Hill therefore changed its testing to a non-proprietary, commercially available "sandwich" enzyme-linked immunosorbent assay (S-ELISA) method to detect residual peanut proteins. FDA subsequently approved Hill's NDA supplement, including product labeling stating that the peanut oil used in the Derma-Smoothe product was routinely tested for peanut proteins using the S-ELISA test and representing that this test could detect peanut proteins to as low as 2.5 parts per million (ppm).

In 2007, Hill submitted another supplement to its NDA in which it proposed to use an amino acid analysis instead of the S-ELISA test, claiming that the amino acid analysis was even more sensitive than the S-ELISA test. This change was not mandated by the FDA, but the FDA approved Hill's supplement. As a result, the current product labeling on Derma-Smoothe includes the following statement: "The peanut oil used in Derma-Smoothe/FS is tested for peanut ...

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