The Legal Status of Unapproved Generic Drugs

Plain Dealer (Cleveland, Ohio), September, 15, 1981.

HEW News, P 79–6 (March 30, 1979).

Ch. 675, §§1–902, 52 Stat. 1040 (1938), as amended Pub. L. No. 87-781, 76 Stat. 780 (codified at 21 U.S.C. §§301-92) (1962).

Ch. 3915, §§1-13, 34 Stat. 768 (1906).

Ch. 675, §§505(a), (b), 52 Stat. 1040, 1052 (1938).

Id. §505(d), 52 Stat. at 1052.

21. U.S.C. §355(d) (1962).

21 U.S.C. §321(p)(1), (2) (1976).

Id. §355(a).

Id. §355(d) (1976).

Id. §321(p)(1) (1968).

Note, Drug Efficacy and the 1962 Drug Amendments, Georgetown Law Journal 60(1):185, 207, n. 141 (October 1971).

Cited in United States v. Articles of Drug (Lannett), 585 F.2d 575, 578 (3d Cir. 1978) [hereinafter cited as Lannett].

Pharmadyne, note 28 infra, 466 F. Supp at 102. n. 5.

See 21 C.F.R. §314.1(f) (1981).

Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973) [hereinafter cited as Hynson]. See also Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973); Ciba Corp. v. Weinberger, 412 U.S. 640 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655 (1973).

Hoffman-LaRoche v. Weinberger, 425 F. Supp. 890 (D.D.C. 1975).

Lannett, supra note 13.

Id. at 576.

Id. at 582, 583 (emphasis in original).

Id. at 583. See 21 C.F.R. §310.3(h)(1)-(5) (1977).

Id. at 583, n. l5. See 21 U.S.C. §351(b) (1976) (provides that a drug is adulterated if its strength differs from, or its quality or purity falls below, compendium standards).

See Hynson , supra note 16.

FDA Associate General Counsel for Drugs, William Vodra, at October 17, 1978 seminar update of the National Association of Pharmaceutical Manufacturers in New York City.

See LaRoche Hoffman , supra note 17.

Id. at 892.

Lannett, supra note 13, at 582.

Pharmadyne Laboratories, Inc. v. Kennedy, 466 F. Supp. 100 (D.N.I. 1979) aff'd on other grounds, 596 F.2d 568 (3d Cir. 1979).

Id. at 102, 103.

Id. at 104, n. 7.

Id. at 103.

Premo Pharmaceutical Laboratories, Inc. v. United States, 475 F. Supp. 52 (S.D.N.Y. 1979), rev'd. 629 F.2d 795 (2d Cir. 1980).

United States v. Generix Drug Corp., 498 F. Supp. 288 (S.D. Fla. 1980), vacated, 654 F.2d 1114 (5th Cir. 1981).

Premo, supra note 32, 629 F.2d 795 (2d Cir. 1980).

United States v. Premo Pharmaceutical Laboratories, 511 F. Supp. 958 (D.N.J. 1981).

Premo, supra note 32, 629 F.2d at 803.

Id. at 805, n.9.

Premo, supra note 35.

See Generix , supra note 33, 654 F.2d 1114 (1981).

The term “drug” means (A) articles recognized in the official United States Pharmacopoeia …; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure of any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph….

See Generix , supra note 33, 654 F.2d at 1117. Some information in an NDA, such as manufacturing techniques, quality control, and the precise manner of formulating the final dosage, are closely guarded trade secrets which the FDA cannot reveal. See also 21 U.S.C, §331(j) (1976), 21 C.F.R. §314.14(g) (1981).

Id. at 1117. See also §321(p)(2), supra note 8.

Id. at 1117.

Id. at 1117, n.4. The court focused on the fact tha the FDA's laxness in enforcing the NDA system prior to Hoffman-LaRoche was due to its own fear that “it would have a difficult time in court contending that a specific version [of an established drug] is a new drug” within §321(p).

Id. at 1118, 1119.

Id. at 1119. See also discussion, supra note 24.

The Generix court stated that it may be good public policy to regulate bioavailability and bioequivalence through the NDA process, but the court felt that it would be inappropriately legislating since the statute did not require such regulation. Id. at 1119, 1120.

In addition to tort liability, some states have laws prohibiting the substitution or dispensing of an unapproved generic product.