Pharmadyne Laboratories, Inc. v. Kennedy

• Decision Date: 10 January 1979
• Docket Number: Cir. A. No. 78-2792.
• Citation: 466 F. Supp. 100
• Parties: PHARMADYNE LABORATORIES, INC., Plaintiff, v. Donald M. KENNEDY, Commissioner of Food and Drugs, United States Department of Health, Education and Welfare, Frederick R. Carlson, Food and Drug Administration, District Director, Newark District Office, and the United States Food and Drug Administration, Defendants.
• Court: U.S. District Court — District of New Jersey

466 F. Supp. 100

PHARMADYNE LABORATORIES, INC., Plaintiff, v. Donald M. KENNEDY, Commissioner of Food and Drugs, United States Department of Health, Education and Welfare, Frederick R. Carlson, Food and Drug Administration, District Director, Newark District Office, and the United States Food and Drug Administration, Defendants.

Cir. A. No. 78-2792.

United States District Court, D. New Jersey.

January 10, 1979.

Bass, Ullman & Lustigman, New York City by Milton A. Bass, Sheldon S. Lustigman, Jacob Laufer, New York City, for plaintiff.

Robert J. Del Tufo, U. S. Atty. by Charles J. Walsh, Asst. U. S. Atty., Newark, N. J., Eugene M. Pfeifer, Associate Chief Counsel for the FDA, Rockville, Md., for defendants.

OPINION AND ADDENDUM

MEANOR, District Judge.

This case arises out of dictum contained in United States v. Articles of Drug (Lannett), 585 F.2d 575 (3d Cir. 1978), rehearing en banc denied.¹ Presently before the court is an application by the plaintiff, Pharmadyne, for a preliminary injunction restraining the Food and Drug Administration (FDA) from litigating the new drug status of two of the plaintiff's products in condemnation actions before the Eastern District of New York and the District of Connecticut.²

The issues posed are, in my judgment, grave and deeply involved with the public health and safety, for the thrust of the plaintiff's argument is that a generic drug manufacturer can market a "me-too" drug without premarketing clearance by the FDA. There is also, I believe, a necessity for prompt decision and appellate review which may give the Third Circuit an opportunity to review its Lannett decision. Such review might halt an FDA assault on various Federal Courts around the nation which has been undertaken in an effort to precipitate a conflict with Lannett so as to provide a vehicle for Supreme Court review. There can be no question that the FDA believes that the Lannett decision is incorrect and will follow and apply it only under extreme compulsion.

Because of the necessity of issuing a prompt decision, there is insufficient time to retell in this opinion the history of drug regulation by the federal government, an understanding of which is necessary in order to place the present issues in context. Fortunately, that history is well documented and can be gleaned from consultation of the following authorities. Weinberger v. Hynson, Westcott & Dunning, 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, 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); United States v. Articles of Drug (Lannett), supra; Hoffman-LaRoche, Inc. v. Weinberger, 425 F.Supp. 890 (D.D.C.1975); Note, Drug Efficacy and the 1962 Drug Amendments, 60 Geo.L.Rev. 85 (1971); Note, The Drug Amendments of 1962: How Much Regulation?, 18 Rutgers L.Rev. 101 (1963).

I. The Lannett Decision.

In Lannett, the government brought a condemnation action against several of Lannett's drugs. The core issue was whether the drugs were "new drugs" within the meaning of 21 U.S.C. § 321(p)(1) and thus could not be marketed without premarketing FDA clearance pursuant to 21 U.S.C. §§ 355(a-d). The entire appellate record in Lannett has been made available to me. The government there achieved summary judgment at the trial level upon the ground that Lannett could not relitigate in the district court the FDA's previous classification of its drugs as "new drugs." United States v. Articles of Drug (Lannett), No. 76-254, slip op. at 4 (E.D.Pa. May 16, 1977). All of the Lannett drugs involved had been marketed with FDA approval while awaiting premarketing clearance under prior FDA procedures invalidated in Hoffman-LaRoche v. Weinberger, supra, a decision in which the FDA acquiesced. That case held that a "me-too" drug could not be marketed without premarketing clearance under the 1962 New Drug Amendments.³ I believe that case and Lannett are in a head-on clash. Following Hoffman-LaRoche, the FDA, without approving Lannett's pending Abbreviated New Drug Applications (ANDAs), 21 C.F.R. § 314.1(a), (b),⁴ sought to condemn Lannett's drugs. After pointing out that Lannett effectively had been denied an opportunity for an administrative hearing on the status of its products as new or old drugs, the Court of Appeals reversed and directed the district court to permit Lannett to contest the FDA's classification of its drugs as "new drugs." 585 F.2d at 581-82.

Thereafter, the court, in Part IV of its opinion, in a considered dictum, proceeded to discuss for the guidance of the district court on remand the definition of "new drug" set forth in 21 U.S.C. § 321(p)(1). In determining whether a product is a new drug that requires premarketing clearance, the court cast aside considerations of bioequivalence, bioavailability, quality control and the potential effect of different manufacturing processes.⁵ It restricted evaluation of new drug status to general safety and effectiveness. The Lannett drugs in question purported to be "me-too" or generic copies of pioneer drugs that had been marketed for substantial periods. The court noted the FDA concession that these pioneer drugs, which Lannett claimed to be copying, were generally recognized by qualified experts as safe and effective. Once this was established, the court indicated that the inquiry was ended and that such "me-too" drugs would not fall within the statutory definition of a new drug. 585 F.2d at 583-84.

In my opinion, there is serious question as to the correctness of the Lannett dictum limiting as it does the definitional criteria to be employed in the determination whether a product is a new drug. As I see it, when a drug manufacturer markets a "me-too" copy of a recognized drug under the Lannett dictum he may do so without any premarketing clearance, leaving the FDA to post-marketing action to remove from commerce any such drug that does not meet recognized therapeutic or purity standards.

This Lannett dictum was a not a mere obiter dictum but was considered or judicial dictum. Even so, I do not believe that I am obliged to follow it, but recognize that it is entitled to the greatest respect and is to be given considerable weight. United States v. Bell, 524 F.2d 202, 205-06 (2d Cir. 1975); Gabbs Exploration Company v. Udall, 114 U.S.App.D.C. 291, 315 F.2d 37, 39 (1962). If the present case were one where Lannett was precisely in point, I would apply and follow it. It will be explained later that Lannett need not be followed even if it is deemed to be controlling in this Circuit. First, however, I shall state the reasons why I believe that the Lannett dictum represents a misconstruction of the definition of new drug contained in 21 U.S.C. § 321(p)(1). That statute⁶ defines the term as follows:

The term "new drug" means—

(1) Any drug . . . the composition of which is such that such drug is not generally recognized . . . (among qualified experts) . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof . . ..

Despite a great deal of past waffling on the point, it is clear that the FDA has now construed the term "new drug" to mean new drug products. See Tr. at 82, 101. Under the FDA's construction, the new drug product of any manufacturer cannot be marketed without premarketing approval of a New Drug Application (NDA) or ANDA, even if that product purports to be en exact copy of a recognized drug — i. e., a "me-too" drug. Tr. at 82. It thus takes issue with Lannett which I construe to mean that a "me-too" drug can be marketed without premarketing NDA or ANDA approval if its therapeutically active ingredients are identical to a recognized drug both chemically and quantitatively.

I believe that the construction advocated by the FDA is, highly arguably, supported by the statute.

It is clear that 21 U.S.C. § 355, requiring NDA approval of new drugs, uses that term to mean new drug products. The Supreme Court has so held. USV Pharmaceutical Corp. v. Weinberger, supra, 412 U.S. at 664, 93 S.Ct. 2498. It should be obvious that the application of the term new drug in § 355 ought to be used to shed light on the meaning of the term as defined in § 321. The statute must be read as a whole. What the Lannett court and plaintiff here, Pharmadyne, do is to compartmentalize the statute. They define new drug only by consulting the language of § 321 and do not look for interpretative guidance elsewhere within its contours.

In § 355(b), an NDA is to have a "full list of articles used as components of such drug" and a "full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug."

Components of a drug may well be (and usually are) things in addition to active ingredients. They may be the binder that permits the active ingredients to be administered in tablet form. Tablets often have an inert coating designed to encase the active ingredients and to permit them to be swallowed. Capsules have an encasement which dissolves in the digestive tract permitting release of the active ingredients. If these inert ingredients were a concern of Congress for a novel drug, it is entirely unclear to me why they would not be of similar concern in the manufacture of a "me-too" product. It was conceded at oral argument that the quality of the inert ingredients may be related to efficacy. Tr. at 17-19. If the tablet is too hard, or the binder indigestible so that the active ingredients are not released properly or timely, the drug's efficacy may be impaired or destroyed. If the covering of a capsule is not readily digestible, the same result may occur.

In addition, as noted above, an NDA must contain a description of manufacturing methods, facilities and controls. Congress obviously deemed...