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BRISTOL-MYERS SQUIBB CO. v. SHALALA

July 21, 1995

BRISTOL-MYERS SQUIBB COMPANY, Plaintiff,
v.
DONNA E. SHALALA, et al., Defendants.



The opinion of the court was delivered by: STANLEY S. HARRIS

 This matter is before the Court on plaintiff's motion for summary judgment, and defendants' motion to dismiss or, in the alternative, for summary judgment. Upon consideration of the motions, the Court grants defendants' motion to dismiss.

 For purposes of a motion to dismiss, "the Court accepts as true all material allegations of the complaint." United Transp. Union v. Interstate Commerce Comm'n, 282 U.S. App. D.C. 38, 891 F.2d 908, 911 (D.C. Cir. 1989), cert. denied, 497 U.S. 1024, 110 S. Ct. 3271, 111 L. Ed. 2d 781 (1990) (citing Warth v. Seldin, 422 U.S. 490, 95 S. Ct. 2197, 2206, 45 L. Ed. 2d 343 (1975)). Although "findings of fact and conclusions of law are unnecessary on decisions of motions under Rule 12 or 56," the Court nonetheless sets forth its analysis. See Fed. R. Civ. P. 52(a).

 Plaintiff is Bristol-Myers Squibb Company ("BMS"), a manufacturer of antibiotics. Defendants, named in their official capacities, are Donna Shalala, Secretary of Health and Human Services, and David Kessler, Commissioner of Food and Drugs. Plaintiff challenges the validity of the determination of the United States Food and Drug Administration ("FDA") that the FDA may approve abbreviated antibiotic drug applications ("AADAs") manufactured from a non-conforming bulk substance. Plaintiff seeks a declaratory judgment that the FDA's ruling is inconsistent with the agency's own regulations and is in violation of the Administrative Procedure Act ("APA"), 5 U.S.C. § 706. The FDA has moved to dismiss the complaint on the ground that plaintiff lacks constitutional standing or, in the alternative, for summary judgment on the ground that its decision is consistent with agency regulations. *fn1"

 The Federal Food, Drug, and Cosmetic Act, ("the Act") 21 U.S.C. § 301 et seq., governs the approval of antibiotic drugs. Under the Act, the original manufacturer of an antibiotic drug product must submit a "full" application to the FDA including the clinical test results of the drug. Clinical testing must demonstrate that the antibiotic satisfies the "characteristics of identity, strength, quality, and purity necessary to adequately ensure safety and efficacy of use." 21 C.F.R. § 314.300(d)(1); see 21 U.S.C. § 357. Upon approval of an antibiotic drug, the FDA issues a "monograph," that is, a regulation which establishes the standards of identity, strength, quality, and purity for the product based on the data submitted in the application.

 By contrast, a generic manufacturer may submit an "abbreviated application" to the agency for "drug products that are duplicates of, or that meet the monograph for, an antibiotic drug for which FDA has approved an application." 21 C.F.R. § 314.92(a)(2). Under the abbreviated procedure, a generic manufacturer is not required to produce the results of clinical testing as long as the finished product satisfies the standards contained in the monograph for the pioneer version of the finished product.

 It is important to note the difference between a finished drug product and a bulk substance. A finished drug product is the form of a drug that is ultimately marketed and administered to patients; a bulk substance, on the other hand, is the active ingredient from which the finished product is derived. 21 C.F.R. § 314.3. Separate monographs are issued for each.

 Finished generic products that have been approved may be rated by the FDA as therapeutically equivalent to the pioneer version of the drug product in the agency's Approved Drug Products with Therapeutic Equivalents (also known as the Orange Book). The rating allows pharmacists to substitute the generic version of the antibiotic for the original product.

 Since mid-1973, plaintiff has held an approved application for the finished product Blenoxane (R), an anti-cancer drug which is derived from the bulk substance sterile bleomycin sulfate. In 1975, the FDA issued two monographs based on the standards established for Blenoxane -- one for the bulk substance and another for the finished drug product.

 On October 4, 1994, the FDA announced in the Federal Register that it had received an application for the bulk substance non -sterile bleomycin sulfate. On the basis of this application, the FDA was prepared to issue a new bulk monograph for the non-sterile bleomycin sulfate substance. See Antibiotic Drugs; Bleomycin Sulfate, 59 Fed. Reg. 50484 (1994). Unlike the bulk monograph for sterile bleomycin sulfate, the proposed bulk monograph for non-sterile bleomycin sulfate did not call for sterility or non-pyrogenicity in the bulk substance. The FDA's October 4 announcement did not affect the standards contained in monograph for the finished product sterile bleomycin sulfate.

 In a letter dated November 9, 1994, the FDA agreed to stay the effective date of the bulk monograph while it reviewed the APA issues raised by plaintiff. The FDA refused to stay the approval of abbreviated applications for finished drug products based on the October 4 monograph stating that "the agency may review and approve a bulk antibiotic drug application that meets applicable requirements whether or not there is a published monograph." Plaintiff's Motion for ...


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