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BRISTOL-MYERS SQUIBB CO. v. SHALALA

March 25, 1996

Bristol-Myers Squibb Company, Plaintiff,
v.
Donna E. Shalala, et. al., Defendants.



The opinion of the court was delivered by: URBINA

 Denying Plaintiff's Motion for a Preliminary Injunction

 This matter comes before the court upon plaintiff's motion for a preliminary injunction; defendants' opposition; defendant/intervenor's opposition and plaintiff's reply. *fn1" The court concludes that plaintiff's motion shall be denied because plaintiff has failed to demonstrate that it has a substantial likelihood of success on the merits; that it will be irreparably harmed; that the balance of harms favors the issuance of an injunction; or that the public interest will be furthered if the court were to grant injunctive relief.

 I. Background

 On March 1, 1996, Bristol-Myers Squibb (Bristol) filed the above-captioned action challenging the Food and Drug Administration's (FDA) decision to approve, for marketing in the United States, a drug called Prevalite TM. This product is manufactured by Upsher-Smith (Upsher) and is a generic competitor to Bristol's cholesterol lowering product Questran (R). *fn2" Plaintiff requests that this court, in effect, set aside the FDA's decision to approve Prevalite TM, and thereby stop the marketing of the competitor product. Bristol also requests that the court order the agency to rescind a document entitled "Interim Guidance Cholestyramine Powder In Vitro Bioequivalence" (Guidance); to rescind or refrain from listing Prevalite TM as bioequivalent to Questran (R) in the FDA's publication "Approved Drug Products With Therapeutic Equivalence Evaluations;" also known as the Orange Book; and to enjoin the FDA from approving an ANDA for a cholestyramine product based solely upon in vitro testing unless the in vitro testing is correlated with in vivo testing data. *fn3" On March 6, 1996, the court denied plaintiff's application for a temporary restraining order which sought the same relief as presently requested.

 The Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. § 301-392, sets forth the requirements for FDA approval of drug products. Generally, in order for a drug to be marketed in the United States, it must first be approved by the FDA. 21 U.S.C. § 355(a). The manufacturer of the original drug product, referred to as the pioneer drug, must establish that the drug is both safe and effective to secure FDA approval. 21 U.S.C. § 355(b). The preparation of the initial application requires extensive reports and tests. Id. The initial application submitted for FDA approval is referred to as a new drug application (NDA). Manufacturers of generic versions of previously approved pioneer drug products are subjected to less rigorous standards.

 Generic manufacturers may submit to the FDA an abbreviated new drug application (ANDA), which must contain "information to show that the [generic] drug is bioequivalent to the [pioneer] drug." 21 U.S.C. § 355(j)(2)(A)(iv). An applicant must show that the rate and extent of absorption of the generic drug does not differ significantly from the rate and extent of absorption of the pioneer drug. 21 U.S.C. § 355(j)(2)(A)(iv). *fn4" An applicant can demonstrate bioequivalence by "in vitro or in vivo bioequivalence studies, or both such studies." 21 U.S.C. § 355(j)(6)(A)(i)(iii). *fn5" However, it is pursuant to agency regulations that one determines when in vitro testing may be utilized in lieu of in vivo. If bioequivalence is established for a generic drug, it is given an "AB" rating in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book); which is relied upon by pharmacists in filling prescriptions. The FDA's AB rating means that the generic drug is considered therapeutically bioequivalent to the pioneer drug.

 Bristol currently markets a cholestyramine drug product Questran (R), pursuant to FDA approval. Cholestyramine is the active ingredient in Questran (R). This drug is administered to patients in order to lower their cholesterol levels. On July 15, 1993, the Division of Bioequivalence in the Office of Generic Drugs of FDA's Center for Drug Evaluation and Research issued the Guidance. The Guidance expresses the FDA's view that "in vivo studies are not necessary to document the bioequivalence of cholestyramine..." The Guidance set forth the kinds of in vitro studies and methods that the FDA would accept to establish bioequivalence in ANDAs for generic cholestyramine.

 On August 18, 1993, Bristol submitted to the FDA a citizen petition (Petition) challenging the Guidance and the protocol it established for the approval of generic cholestyramine drug products. Bristol asserts that the FDA has inexplicably changed its bioequivalence policy from one that required both in vivo and in vitro testing to demonstrate the bioequivalence of new forms of cholestyramine, to one which only required in vitro testing. Bristol takes issue with the FDA's position that in vivo studies are not necessary to establish the bioequivalence of cholestyramine drug products. The petition thus requests that the FDA rescind the Guidance and refrain from approving any application for cholestyramine products in which the applicant was allowed to demonstrate bioequivalence through in vitro tests. In its Petition, Bristol sought to show that there was no scientific evidence to establish a correlation between in vivo and in vitro tests for cholestyramine. The FDA, pursuant to its regulations dealing with such petitions, provided Bristol with an interim response. See 21 C.F.R. § 320.22(d)(3); 21 C.F.R. § 10.30(e)(2). However, the FDA itself acknowledges that this initial response was approximately twenty-two days late. A final response was finally submitted with the defendants opposition to Bristol's motion for a preliminary injunction.

 On February 22, 1996, the FDA approved an ANDA for Prevalite TM. The agency concluded that Prevalite TM is bioequivalent to Bristol's Questran (R) product based on in vitro studies of the kind specified in the Guidance.

 II. Analysis

 In order to succeed on a motion for a preliminary injunction, a movant must demonstrate: (1) a substantial likelihood of success on the merits; (2) that irreparable injury will result in the absence of the requested relief; (3) other interested parties will not suffer substantial harm if the injunction is granted; and (4) that the public interest favors entry of a preliminary injunction. WMATA v. Holiday Tours, Inc., 182 U.S. App. D.C. 220, 559 F.2d 841, 843 (D.C.Cir. 1977); Sea Containers, Ltd. v. Stena AB, 281 U.S. App. D.C. 400, 890 F.2d 1205, 1208 (D.C.Cir. 1989). A preliminary injunction is not granted as a matter of right. Eli Lilly and Co. v. Premo Pharmaceutical Labs., 630 F.2d 120, 136 (3d Cir. 1980), cert. denied, 449 U.S. 1014, 66 L. Ed. 2d 473, 101 S. Ct. 573, (1980). Injunctive relief is an extraordinary remedy and must be sparingly granted. Dorfmann v. Boozer, 134 U.S. App. D.C. 272, 414 F.2d 1168 (D.C.Cir. 1969).

 A district court is to balance the four factors. Grigsby Brandford & Co., Inc. v. U.S., 869 F. Supp. 984, 1003 (D.D.C. 1994). Consequently, although a "particularly strong likelihood of success on the merits" may entitle a movant to relief upon "a relatively slight showing of irreparable injury," some showing of irreparable injury is always required, "since 'the basis for injunctive relief in the federal courts has always been irreparable harm.'" Cityfed Fin. Corp. v. OTS, 313 U.S. App. D.C. 178, 58 F.3d 738, 747 (D.C.Cir. 1995) (quoting Sampson v. Murray, 415 U.S. 61, 88, 39 L. Ed. 2d 166, 94 S. Ct. 937 (1974)). Likewise, a court may accept a showing that the movant has a "substantial case on the merits" instead of the ...


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