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SCHERING CORP. v. FDA

April 25, 1994

Schering Corp., Plaintiff,
v.
Food and Drug Administration, Defendant.



The opinion of the court was delivered by: H. LEE SAROKIN

 Sarokin, District Judge

 Before the court are plaintiff's motion for summary judgment and defendant's cross-motion for judgment on the pleadings.

 Background

 Schering Corporation ["Schering"], a manufacturer of certain "pioneer" drug products, *fn1" brings this action to challenge the Food and Drug Administration's ["FDA"] 1992 regulation under which generic competitors of pioneer drugs are approved. See 21 C.F.R. § 320.1(e). Title I of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) [the "Hatch-Waxman Amendments" or "1984 Amendments"] to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394, provides an abbreviated new drug application procedure for FDA approval of generic drugs: the pioneer drug and its generic copy must be "bioequivalent" for FDA's approval without clinical testing to prove that the generic is safe and effective. 21 U.S.C. § 355(j)(7)(B).

 The legislative history of the 1984 Amendments states that:

 
The purpose of Title I of the bill is to make available more low cost generic drugs by establishing a generic drug approval procedure for pioneer drugs first approved after 1962.

 Schering Corp. v. Sullivan, 782 F. Supp. 645, 650 (D.D.C. 1992), vacated sub. nom., Schering Corp. v. Shalala, 302 U.S. App. D.C. 35, 995 F.2d 1103 (D.C.Cir. 1993); H.R.Rep. No. 857 (Part I), 98th Cong., 2d Sess. 14 (1984), reprinted in U.S. Code Cong. & Admin. News 1984, at 2647. However, Congress had another equally important consideration in mind -- the safety of generic drugs approved through this abbreviated procedure. See Tri-Bio Laboratories, Inc. v. U.S., 836 F.2d 135, 139 (3d Cir. 1987), cert. denied, 488 U.S. 818, 102 L. Ed. 2d 35, 109 S. Ct. 57 (1988) ("The 1984 Amendments . . . reflect a statutory compromise of the competing concerns").

 Prior to 1984, manufacturers desiring to sell generic copies of drugs approved after 1962 were required to submit full new drug applications. This involved a time consuming and expensive process which included comprehensive animal and human testing to show that the new drug is safe and effective. The 1984 Amendments free the manufacturer or distributor of a generic drug product from the clinical trial requirements as long as it could prove that the generic is bioequivalent to the already-approved pioneer drug it copies.

 The Food, Drug, and Cosmetic Act provides two definitions of "bioequivalent," one of which is as follows:

 
A drug shall be considered to be bioequivalent to a listed drug if --
 
(i) 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 when administered at the same molar dose . . . under similar experimental conditions . . . .

 21 U.S.C. § 355(j)(7)(B) (emphasis added). The second definition provides for intentional differences in ...


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