drug within the meaning of 21 U.S.C. § 321(p) (1970).
On the contrary, Hoffmann-LaRoche argues that the FDA's action is another example of its failure to follow the 1962 New Drug Amendments. Like the situation condemned in American Public Health Assoc. v. Veneman, supra, the FDA is again acting contrary to the clear statutory directives of section 355. Plaintiff contends that the plain meaning of section 355 dictates that once the FDA requires a new drug application to be filed, then the approval process must be completed before such drug can be marketed. See, Virginia March v. United States, 165 U.S.App.D.C. 267, 506 F.2d 1306, 1313-14 (1974); American Public Health Assoc. v. Veneman, 349 F. Supp. 1311, 1316 (D.D.C. 1972). It argues that the Congressionally expressed interest in public health and safety mandates no other choice. See, S.Rep. No. 1744, 87th Cong., 2d Sess., pt. 2, 36 (1962), U.S. Code Cong. & Admin. News 1962, p. 2884. Further, it claims that the deposition testimony of Dr. Marvin Seife, FDA's Director, Division of Generic Drug Monographs, demonstrates that no undue administrative burdens would be imposed by such a requirement.
To understand how the present state of affairs has arisen, it is necessary to chronicle some of the administrative actions taken in the implementation of the 1962 amendments with respect to me-too drugs. On January 24, 1968, at a government industry conference, the FDA announced that it would apply the applicable effectiveness findings from the National Academy of Sciences-Natural Research Council studies to all drugs, identical, related, or similar drug products. All opinions previously given to the effect that a drug was no longer a new drug were revoked in regulations published on May 18, 1968. 33 Fed.Reg. 7758 (1968). That same day a proposed procedure to determine by rule making those drugs for which a full or abbreviated new drug application would no longer be required was published. 33 Fed.Reg. 7762 (1968). These regulations were not promulgated in final form. Thus in 1968, virtually all human prescription drugs were regarded as new drugs. Regulations governing the filing and content of abbreviated new drug applications were adopted in February 1969. 34 Fed.Reg. 2673 (1969). They provide that an abbreviated new drug application need not contain safety and effectiveness data, except for those drugs for which a drug efficacy study implementation notice, previously published in the Federal Register, requires submission of clinical data adequate to assure the bioavailability of each drug product.
On July 14, 1970, the FDA issued a general notice establishing uniform conditions for the marketing of drugs covered by a drug efficacy study implementation notice. 35 Fed.Reg. 11273 (1970). This notice is of central importance to the FDA's view of this litigation. Essentially, it provides that any person who does not hold an approved new drug application and who distributes or intends to distribute a drug covered by a drug efficacy study implementation notice must submit a full or abbreviated new drug application. The notice does not explicitly state that a me-too drug could be marketed prior to approval of an abbreviated or full new drug application. It was implicit, the FDA argues, that such marketing would be permitted. To hold otherwise would be to give an unfair competitive advantage to manufacturers of identical, related or similar drug products marketed prior to a drug efficacy notice by allowing them to remain on the market pending approval of an abbreviated new drug application. Competitors' products would be kept off the market until approval was granted. Of particular importance to this case, by Federal Register notice on July 11, 1972, the FDA declared all compounds containing chlordiazepoxide subject to new drug application requirements. Abbreviated new drug applications were required to be submitted. 37 Fed. Reg. 13562 (1972).
On June 18, 1973, the Supreme Court decided four cases interpreting the 1962 amendments. See, Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S. Ct. 2469, 37 L. Ed. 2d 207 (1973); Ciba Corp. v. Weinberger, 412 U.S. 640, 93 S. Ct. 2495, 37 L. Ed. 2d 230 (1973); Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S. Ct. 2488, 37 L. Ed. 2d 235 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S. Ct. 2498, 37 L. Ed. 2d 244 (1973). These cases sustained the FDA's application of all drug efficacy study implementation notices to me-too drug products and upheld the agency's primary jurisdiction to determine the status of drugs under the Act.
Preliminarily, the FDA suggests that Count One of plaintiff's complaint is moot because the FDA approved the new drug application of Zenith Labs on March 7, 1975, during the pendency of this litigation. Count One challenges the FDA's policy as violative of 21 U.S.C. § 355 (1970). This general policy continues in operation with respect to whole generic classes of drugs. Voluntary cessation of the alleged wrongful conduct in one instance, while it continues in all other areas, has not conveniently mooted this portion of plaintiff's complaint. United States v. Concentrated Phosphate Export Ass'n., 393 U.S. 199, 202-204, 89 S. Ct. 361, 21 L. Ed. 2d 344 (1968); Southern Pacific Terminal Co. v. ICC, 219 U.S. 498, 511, 31 S. Ct. 279, 55 L. Ed. 310 (1911); Cf. Preiser v. Newkirk, 422 U.S. 395, 95 S. Ct. 2330, 45 L. Ed. 2d 272 (1975); National Broadcasting Co., Inc. v. FCC, 170 U.S.App.D.C. 173, 516 F.2d 1101 (1975).
Reaching the merits of plaintiff's statutory argument, the Court holds that the FDA's policy of permitting new drugs to be marketed without an approved new drug application contravenes the clear statutory requirement of preclearance mandated by 21 U.S.C. § 355 (1970). The FDA's choice of policy is not within the intendment of the 1962 New Drug Amendments and the legislative scheme they embody. American Public Health Assoc. v. Veneman, 349 F. Supp. 1311 (D.D.C.1972).
Further, the action of the FDA in permitting such marketing of large classes of me-too drugs violates its own regulations. See, 21 C.F.R. §§ 314.1(a)(f), 314.012 (1974); Nader v. Nuclear Regulatory Commission, 168 U.S.App.D.C. 255, 513 F.2d 1045, 1051 (1975); Borough of Lansdale v. FPC, 161 U.S.App.D.C. 185, 494 F.2d 1104, 1113 & n.42 (1974). The implication that the FDA seeks to find in the language of the July 14, 1970 notice is an impermissible one. The Court recognizes that the FDA is to be given the administrative flexibility to make regulations and to determine the new drug status of individual drugs or classes of drugs. See, Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653, 93 S. Ct. 2488, 37 L. Ed. 2d 235 (1973); National Nutritional Foods Ass'n. v. Weinberger, 512 F.2d 688, 696-98 (2d Cir. 1975). Certainly it has the power to promulgate regulations that adopt a monograph procedure for human prescription drugs similar to that adopted for over-the-counter drugs whereby a drug or drugs may be declared to be no longer new drugs. See, 21 C.F.R. § 330.10 (1974). The FDA can regulate the bioequivalence and special manufacturing problems through its general rule-making power, 21 U.S.C. § 371 (1970). However, the argument that the FDA lacks the administrative resources to insure compliance with section 355 cannot be permitted to postpone to some indefinite future date the implementation of the required preclearance approval of new drug applications. See, Calvert Cliffs' Coordinating Committee, Inc. v. United States Atomic Energy Commission, 146 U.S.App.D.C. 33, 449 F.2d 1109, 1115 (1971).
The Court gives particular weight to the fact that the amicus curiae is the Pharmaceutical Manufacturers Association whose members numerically would favor me-too companies, but said Association calls attention to the dangers inherent in releasing untested me-toos for ingestion by the general public.
Summary judgment will therefore be entered for the plaintiff.
Defendants will be permanently enjoined from implementing its policy which permits the introduction into interstate commerce without an approved new drug application of prescription drugs which the FDA has previously declared to be new drugs within the meaning of 21 U.S.C. § 321(p) (1970).