Pharmadyne Laboratories, Inc. v. Kennedy

6 Citing cases

  1. U.S. v. Premo Pharmaceutical Laboratories

    511 F. Supp. 958 (D.N.J. 1981)   Cited 9 times

    yler Pharmacal Distributors, Inc. v. HEW, 408 F.2d 95 (7th Cir. 1969); United States v. Articles of Drug (Hormonin), 498 F. Supp. 424 (D.N.J. 1980); United States v. Articles of Food and Drug, 444 F. Supp. 266 (E.D. Wis. 1978); United States v. Articles of Drug . . . "Colchicine," 442 F. Supp. 1236 (S.D.N.Y. 1978); United States v. Lanpar Co., 293 F. Supp. 147 (N.D.Tex. 1968), only recently has the question been presented in the context of whether drug products that are generic versions of products with approved NDAs are "new drugs" for the purposes of section 321(p). Prior to this action only a limited number of cases have addressed this issue. In addition to the Premo decisions in the court of appeals and district court [ 475 F. Supp. 52 (S.D.N.Y. 1979)], see United States v. Articles of Drug (Lannett), 585 F.2d 575 (3d Cir. 1978) ("Lannett"); United States v. Generix Drug Corp., 498 F. Supp. 288 (S.D.Fla. 1980); United States v. Pharmacal, Inc., No. 78-3685 (S.D.Fla. Mar. 2, 1979); Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100 (D.N.J.), aff'd on other grounds, 596 F.2d 568 (3d Cir. 1979) (" Pharmadyne"). These decisions delineate essentially three positions on the generic/new-drug issue: (1) that espoused in dictum by the Court of Appeals for the Third Circuit in Lannett, which, broadly interpreted, suggests that a product is not a "new drug" if "its therapeutically active ingredients are identical with those of a recognized and approved drug both chemically and quantitatively"; (2) that formulated by the district court in Premo — and adopted substantially by the district court in Generix — which held that in certain circumstances the question of safety and efficacy, as determinative of the new-drug issue, is one for the court; and (3) that set forth by the Court of Appeals for the Second Circuit in the Premo appeal, reversing the district court, which held that the only issue to be decided by a district court presented with a new-drug question is whether, based on use to a material extent or for a material time a

  2. Premo Pharmaceutical Laboratories, Inc v. U.S.

    629 F.2d 795 (2d Cir. 1980)   Cited 35 times
    Holding that referring the issue to FDA would be "wasteful and duplicative" in case where FDA had filed seizure actions after rejecting Premo's attempt to file drug with agency

    Id. at 55. See in accord Pharmadyne Laboratories, Inc. v. Kennedy, 466 F.Supp. 100, 104 (D.N.J.), aff'd., 596 F.2d 568, 571 n.6 (3d Cir. 1979). The Government contended, relying on the language of 21 U.S.C. § 321(p), that any drug product constitutes a "new drug" unless it is shown that the drug is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use . . .

  3. U.S. v. Undetermined Quant. of Various Arts

    675 F.2d 994 (8th Cir. 1982)   Cited 8 times

    A drug that is less bioavailable than that for which it is substituted will deliver less of its active ingredient than expected; a drug that is more bioavailable than that which it replaces presents the danger of overdosage.United States v. Premo Pharmaceutical Laboratories, Inc., 511 F. Supp. 958, 962-63 (D.N.J. 1981) ( Premo II) (footnote omitted) (excellent discussion of factors which may affect bioavailability); see United States v. Generix Drug Corp., 654 F.2d 1114 (5th Cir. 1981) (Generix), cert. granted, ___ U.S. ___, 102 S.Ct. 1610, 71 L.Ed.2d 847 (1982); Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795 (2d Cir. 1980) (Premo I); United States v. Articles of Drug (Lannett Co.), 585 F.2d 575 (3d Cir. 1978) (Lannett); see also Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100, 103 (D.N.J.) (Pharmadyne), aff'd on other grounds, 596 F.2d 568 (3d Cir. 1979). The government's basic position in the present case, and in the above cited cases, all of which involve generic drugs, is that because many factors, particularly the manufacturing process and choice of inactive ingredients, may affect a generic drug's bioavailability and thus its bioequivalence to its pioneer drug, the generic drug is a "new drug" (or "new animal drug") and thus subject to premarketing clearance by the FDA, even though the pioneer drug has already been approved by the FDA. Not surprisingly, the manufacturers of generic drugs oppose the FDA's position. Basically the position of the manufacturers is that because the generic drug contains the same active ingredient as the FDA-approved pioneer drug, the generic drug is not a "new drug" (or "new animal drug") and thus not subject to FDA premarketing clearance.

  4. U.S. v. Undetermined Quantities of an Art.

    709 F. Supp. 511 (D.N.J. 1987)   Cited 3 times

    See id. at 455, 103 S.Ct. at 1299; Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795, 805 (2d Cir. 1980). For that reason, courts have rejected arguments that studies of approved drugs containing the same active ingredients as a newly marketed product, in and of themselves, constitute substantial evidence that the new product is generally recognized as safe and effective. See, e.g., United States v. Undetermined Quantities of Various Articles of Drug, 675 F.2d 994, 1001-02 (8th Cir. 1982); Premo Pharmaceutical Laboratories, Inc., 629 F.2d at 805; United States v. Premo Pharmaceutical Laboratories, Inc., 511 F. Supp. 958, 965-973 (D.N.J. 1981); Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100, 102-03 (D.N.J. 1979), aff'd, 596 F.2d 568, 570 (3d Cir. 1979).United States v. Articles of Drug (Lannett), 585 F.2d 575 (3d Cir. 1978), cited by G W, is neither binding nor persuasive authority to the contrary.

  5. United States v. Generix Drug Corp.

    498 F. Supp. 288 (S.D. Fla. 1980)   Cited 5 times

    The evidence presented to this court is clear: differences in excipients can affect bioavailability and bioequivalence, and bioavailability and bioequivalence are intimately intertwined with safety and effectiveness. In Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100, 102 (D.C.N.J. 1979) a district court within the Third Circuit, commenting on Lannett, extensively criticized the Third Circuit's dictum which it perceived as a serious misconstruction of the statutory definition of the term "new drug". In reasoning to the conclusion that the FDA's argument was indeed supported by the statute, the court stated:

  6. Premo Pharmaceutical Laboratories, Inc. v. U.S.

    475 F. Supp. 52 (S.D.N.Y. 1979)   Cited 4 times
    In Premo, the court considered a suit for declaratory relief brought by a manufacturer seeking a declaration that its product was not a "new drug".

    As a result it would frustrate the long-recognized purpose of the Act to allow the marketing of safe and effective "me-too" drug products without costly and time-consuming FDA approval. See Weinberger v. Hynson, Westcott Dunning, 412 U.S. 609, 614, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); Lannett, supra, 585 F.2d at 583; cf. Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100 (D.N.J. 1979), aff'd on other grounds, 596 F.2d 568 (3d Cir. 1979). The defendants have also argued that a drug product is a "new drug" if its combination of excipients differs in any way whatsoever from the combination of excipients in an approved and recognized drug product, even if the active ingredients in the two drug products are identical and even if the excipients in the "me-too" product are individually recognized as safe.