The opinion of the court was delivered by: FULLAM
In this action plaintiff seeks a declaratory judgment that Regulation 3.63 of the Federal Drug Administration, 21 C.F.R. 3.63 is illegal. The prayer for relief also asks that the F.D.A. be enjoined from enforcing Regulation 3.63, and that the plaintiff's product, Obestat, be declared safe and effective for its prescribed use. Presently before the Court is the government's motion for summary judgment pursuant to Fed. R. Civ. P. 56.
By way of background, prior to 1962 a drug was not considered a new drug subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355, if it was generally recognized by qualified medical experts to be safe for its intended use. From and after October 10, 1962, a drug is considered a new drug unless it is generally recognized to be both safe and effective. However, a grandfather clause, P.L. 87-781; 76 Stat. 781, was included in the 1962 amendments which provides that if, prior to the effective date of the amendment, a drug was (1) commercially used or sold; (2) not a new drug under the pre-1962 definition, and (3) not the subject of a pending new drug application, the "effectiveness" requirement of the 1962 amendment was not applicable.
Regulation 3.63, adopted April 11, 1968, provides:
"§ 3.63. Thyroid-containing drug preparations intended for treatment of obesity in humans.
"(b) Combinations of thyroid or other thyrogenic drugs with central nervous system stimulants with or without other drug substances when offered for or as adjuncts to the treatment, control, or management of obesity not related to hypothyroidism are regarded as misbranded. Such combinations when offered for obesity in humans directly attributable to established hypothyroidism are regarded as new drugs within the meaning of section 201(p) of the Federal Food, Drug and Cosmetic Act."
It is agreed by the parties that Obestat is a drug within the meaning of the Act and that Regulation 3.63 is applicable to it.
The significance of this regulation lies in the fact that plaintiff's product, and many others, are effectively categorized as a new drug within the meaning of 21 U.S.C. § 321(p). As a consequence of this, the marketing of Obestat without approval of a new drug application filed pursuant to 21 U.S.C. § 355 exposes the plaintiff to seizure of its product, 21 U.S.C. § 334, injunctive proceedings, 21 U.S.C. § 332, and criminal prosecution, 21 U.S.C. § 333.
Apparently, the government's motion for summary judgment is premised on the theory that this Court is precluded by the doctrine of primary jurisdiction from granting the plaintiff's request for relief that Obestat be declared safe and effective for its prescribed use. In support of this theory, the government argues that the new drug qualification procedures of section 355 are available to resolve this precise issue, and that, consequently, this Court should not and cannot grant the relief requested.
The determination of the actual safety and effectiveness of a particular drug is one of the essential functions of the F.D.A. Because of the complex and technical nature of the factual issues and the expertise necessary to evaluate these facts, the determination of the safety and effectiveness of Obestat is best left to the F.D.A. in the first instance. There is no doubt that the doctrine of primary jurisdiction is applicable to this case. Far East Conference v. United States, 342 U.S. 570, 72 S. Ct. 492, 96 L. Ed. 576 (1952); Tyler Pharmacal Dist. Inc. v. United States Dept. of H.E.W., 408 F.2d 95 (7th Cir. 1969); AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir.) cert. denied, 393 U.S. 825, 89 S. ...