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SERONO LABS., INC. v. SHALALA

July 25, 1997

SERONO LABORATORIES, INC., Plaintiff,
v.
DONNA E. SHALALA, et al., Defendants.



The opinion of the court was delivered by: SPORKIN

 This matter is before the Court on Plaintiff's motion for a preliminary injunction. The Court has considered the motion and the opposition thereto and heard argument on July 1, 1997.

 The Plaintiff, Serono Laboratories, Inc. ("Serono"), manufacturer of the infertility drug Pergonal, contends that the FDA erred in approving an abbreviated new drug application ("ANDA") which permits Ferring Laboratories to market Repronex, a generic alternative to Pergonal. The Court finds the FDA failed to comply with its governing statute and its own regulations in approving the ANDA. The Court also has certain questions related to the safety of Repronex. Based on this finding, the Court grants Plaintiff's motion for a preliminary injunction, barring the marketing of Repronex in the United States.

 BACKGROUND

 I. The FDA's Regulatory Scheme

 The FDA has the authority to regulate the manufacture, distribution, and sale of drugs within the United States pursuant to the Food, Drug, and Cosmetics Act ("FFDCA"). 21 U.S.C. § 355(a). Pharmaceutical companies seeking approval to market a new drug (also known as a "pioneer" drug) initiate this process by filing a new drug application ("NDA") with the FDA. A successful application will detail the numerous tests undertaken by the pharmaceutical company in its effort to demonstrate the safety and effectiveness of the candidate drug. 21 U.S.C. § 355(d). Only after the FDA approves an NDA can the applicant market the product in the United States. 21 U.S.C. § 355(a).

 Specifically, in order for an ANDA involving a drug product administered by injection to be approved, an applicant must demonstrate and the FDA must conclude that "the active ingredients [of the generic product] are the same as those of the [pioneer] drug." 21 U.S.C. § 355(j)(3)(C)(ii). The agency's implementing regulations state that "for determining the suitability of an abbreviated new drug application, the term 'same as' means identical in active ingredients." 21 C.F.R. § 314.92(a)(1).

 The Hatch-Waxman Amendments also require that an ANDA applicant demonstrate that a generic drug is not unsafe "because of the type or quantity of inactive ingredients included. . ." 21 U.S.C. § 355(j)(3)(H)(ii). In order to meet these stringent requirements, regulations mandate that the "FDA . . . refuse to approve . . . [an] abbreviated new drug application unless [the applicant drug] contains the same inactive ingredients . . . in the same concentrations as the listed drug . . ." 21 C.F.R. § 314.127(a)(8)(ii)(B). The agency's rationale for requiring equivalence with regard to inactive ingredients is based on its conclusion "that changing the inactive ingredients in a drug can adversely affect the drug's safety or effectiveness." 54 Fed. Reg. 2872, 28902 (July 10, 1989).

 II. The Serono and Ferring Products

 In 1969 the FDA approved an NDA for Pergonal, a drug marketed by the plaintiff, Serono. Pergonal is an injectable, intramuscular medication which treats female and male infertility. Its active ingredients, *fn1" follicle stimulating hormone ("FSH") and leteunizing hormone ("LH"), are derived from the urine of post-menopausal women and make up five percent of the drug's overall chemical composition. Because the drug is crafted from mammalian urine, it is labeled a menotropins product. The remaining ninety-five percent of the drug contains lactose and uncharacterized, urinary protein ("UUP") impurities, both inactive ingredients. *fn2" Certain of the UUP are biologically active and may have effects on individuals who undergo fertility therapy.

 On June 21, 1990, Lederle Laboratories filed an ANDA with the FDA for approval of Repronex, a generic fertility drug based on Serono's Pergonal. This application was transferred to Ferring Laboratories ("Ferring") on July 3, 1996, and was subsequently approved by the FDA on January 30, 1997. In connection with its approval of the ANDA for the generic product, the FDA relied on Serono's Pergonal as the pioneer drug (or reference listed drug) for which pre-clinical and clinical studies had been undertaken, since it concluded that Repronex was "therapeutically similar" to Pergonal. On the basis of this approval, the FDA assigned an "AB" rating to Repronex in its publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book." Physicians and pharmacists, who rely upon this document in writing and filling prescriptions, consider the "AB" rating to mean that the generic product is fully substitutable for the pioneer drug.

 On December 8, 1992, after learning that at least one ANDA for menotropins was being considered by the FDA's Office of Generic Drugs, Serono filed a citizen petition with the FDA pursuant to the agency's procedures published at 21 C.F.R. § 10.30. The FDA regulations require the agency to respond to a citizen petition within 180 days of its submission. 21 C.F.R. § 10.30(e)(2). When no action was taken on Serono's petition for over four years, the Plaintiff on May 30, 1997 filed its complaint for declaratory and injunctive relief. *fn3" Plaintiff's complaint challenging the approval of an ANDA for Repronex has four counts: (1) failure to establish that Repronex had the same active ingredients; (2) failure to establish that Repronex had the same inactive ingredients and composition; (3) inconsistent agency action; and (4) agency action unreasonably delayed and unlawfully withheld. *fn4" Serono now moves for a preliminary injunction.

 The agency argues that its approval of the ANDA for Repronex was consistent with the Hatch-Waxman Amendments and the applicable regulations. With respect to the active ingredients, the FDA argues that the active ingredients of Repronex are the "same" as those of Pergonal for the purposes of the FFDCA. With respect to the inactive ingredients, the agency believes that the Repronex ANDA should be judged by the standards in place at the time the application was submitted in 1990, and not the more stringent implementing regulations established in 1992.

 ANALYSIS

 Four factors must be considered in deciding whether to issue a preliminary injunction: (1) the likelihood of success on the merits; (2) irreparable harm to the plaintiff; (3) whether the issuance of a stay would substantially harm other interested parties; and (4) a determination of where the public interest lies. Washington Metro Area Transit Comm'n v. Holiday Tours, Inc., 182 U.S. App. D.C. 220, 559 F.2d 841, 843 (D.C. Cir. 1977). A party need not establish all four factors in order to prevail. Rather "if the arguments for one factor are particularly strong, an injunction may issue even if the ...


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