US v. 225 Cartons of an Article of Drug
| Citation | 687 F. Supp. 946 |
| Decision Date | 08 March 1988 |
| Docket Number | Civ. A. No. 86-3877. |
| Parties | UNITED STATES of America, Plaintiff, v. 225 CARTONS, MORE OR LESS, OF AN ARTICLE OF DRUG, each carton containing 12/100 capsule bottles, labeled in part: (carton) "* * * Sandoz Pharmaceuticals East Hanover, NJ 07936 * * *" with an area cut out showing bottle labeling described below (bottle) "* * * Fiorinal with Codeine No. 1 * * * Sandoz Inc. East Hanover, NJ * * *" (insert attached to bottle) "Fiorinal with Codeine Capsules * * *" 144 packages, more or less, of an article of drug, each package containing 12/100 capsule bottles and covered by an unlabeled, see-through, cellophane overwrap, labeled in part: (bottle) "* * * Fiorinal with Codeine No. 2 * * * Sandoz Inc. East Hanover, NJ * * *" (insert attached to bottle) "Fiorinal with Codeine Capsules * * *" 4,780 blister packs, more or less, of an article of drug, each blister pack containing 20 capsules and one insert, labeled in part: (blister pack) "* * * Fiorinal with Codeine No. 2 Sample * * * Sandoz, Inc. East Hanover, N.J. 07936 * * *" and undetermined quantities of the articles of drug, Fiorinal with Codeine No. 1 and Fiorinal with Codeine No. 2, packaged and labeled as described above, Defendants. |
| Court | United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey |
Samuel A. Alito, Jr., U.S. Atty. by Jerome L. Merin, Asst. U.S. Atty., Deputy Chief, Civ. Div., Newark, N.J., Jacqueline H. Eagle, Civ. Div., Dept. of Justice, Office of Consumer Litigation, Washington, D.C., and Eric M. Blumberg, Associate Chief Counsel for Enforcement, Food and Drug Adm'n, Rockville, Md., for plaintiff.
Shanley & Fisher by Robert A. Boutillier, Morristown, N.J., for Claimant Sandoz Pharmaceuticals Corp.; Kleinfeld, Kaplan & Becker by Peter O. Safir, Bonnie Beavers, Washington, D.C., and Sandoz Pharmaceuticals Corp. by Anne S. Davidson, East Hanover, N.J., of counsel.
Plaintiff is the United States which instituted this action on behalf of the Food and Drug Administration (FDA). The defendants are two prescription drug products, FIORINAL WITH CODEINE NO. 1 and NO. 2 (FWC No. 1 and FWC No. 2). The claimant is Sandoz Pharmaceutical Corporation (Sandoz) which manufacturers and distributes the FWC products.
This is an in rem seizure action brought under 21 U.S.C. § 334. The complaint for forfeiture alleges that the seized FWC No. 1 and FWC No. 2 are "new drugs" within the meaning of 21 U.S.C. § 321(p) which may not, without violating 21 U.S.C. § 355(a), be introduced into interstate commerce because a new drug application (NDA) has not been approved by the FDA pursuant to 21 U.S.C. § 355(b). Further, the complaint alleges that the FWC products are misbranded within the meaning of 21 U.S.C. § 352(f)(1) because their labeling fails to bear adequate directions for use, and they are not exempt from this requirement because they are unapproved "new drugs".
After the drugs were seized by the United States Marshal pursuant to court order, Sandoz intervened and filed a claim. In its answer it admitted that the court has jurisdiction, that the seized articles are drugs located within the jurisdiction of the court and that the seized articles were manufactured from one or more components which were shipped in interstate commerce. Sandoz denied that the FWC products are "new drugs" within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (the FDC Act) and that they are misbranded. Further, Sandoz defended on the ground that the case must be dismissed because the FDA did not develop an administrative record pursuant to 5 U.S.C. § 554 before it filed its complaint for forfeiture.
The FDA moved for summary judgment. It contends that to obtain judgment on the "new drug" charge it need only establish (i) that no NDA for the FWC products has been approved by the FDA (which Sandoz will admit) and (ii) that the FWC products are "new drugs". The FDA further contends that to obtain judgment on the misbranding charge it need only prove the same two facts and that the FWC products are prescription drugs (which Sandoz will admit). Thus, according to the FDA, the only contested issue is whether the FWC product is a new drug. The FDA submitted in support of its summary judgment motion exhibits and declarations of experts which, it contends, establish that there is no genuine issue of material fact and that the FWC product is indeed a new drug.
In response to FDA's motion Sandoz submitted declarations to support its contention that FWC No. 1 and FWC No. 2 are not new drugs and it moved pursuant to Fed.R.Civ.P. 56(f) for a continuance to permit discovery to oppose the motion for summary judgment.
The FDA Act establishes a system for the premarket clearance of drug products. 21 U.S.C. § 355. Under the Act as adopted in 1938, 52 Stat. 1040, no new drug could lawfully be introduced into commerce unless and until an NDA for that product had been filed with and approved by the FDA. See 21 U.S.C. § 355(a), 52 Stat. 1052. The 1938 Act defined a new drug as any product which, among other things, was not "generally recognized" by qualified experts as safe for its intended use. See § 201(p), 52 Stat. 1041.
Congress adopted amendments to the FDA Act in 1962. See Drug Amendments of 1962, Pub.L. No. 87-781, 76 Stat. 780. Under the 1962 amendments manufacturers were required to show that a new drug product was effective as well as safe for its intended use. 21 U.S.C. § 355(a) and (b). A "new drug" was defined as "any drug ... the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof...." 21 U.S.C. § 321(p).
Under the 1962 amendments a manufacturer seeking approval of an NDA was required to submit "substantial evidence" of the product's safety and effectiveness. The statute defined "substantial evidence" as "evidence consisting of adequate and well-controlled investigations, including clinical investigations ... on the basis of which it could fairly and responsibly be concluded ... that the drug will have the effect it purports ... to have under the conditions of use prescribed ... in its labeling...." 21 U.S.C. § 355(d). Sandoz FWC products are exempt from the FDA's premarket clearance procedures only if they are "generally recognized" as safe and effective for their intended uses. 21 U.S.C. § 321(p).
The 1962 amendments required the FDA to evaluate the effectiveness of all drug products, not grandfathered, which had been placed on the market since 1938. To do this, the FDA enlisted the services of the National Academy of Sciences—National Research Council (NAS-NRC), which, after investigation, made recommendations to the FDA regarding the effectiveness of therapeutic classes of products. As the FDA reviewed the NAS-NRC recommendations, it published drug efficacy study implementation (DESI) notices in the Federal Register which rated products as to their effectiveness for specific labeled indications. Products that were found to be effective were still regarded as new drugs and manufacturers were required to supplement their NDAs to conform to conditions imposed by the DESI notices. In the period shortly after adoption of the 1962 amendments the FDA issued informal opinions with respect to some drug products that they found were not new drugs. However, in 1968 the FDA adopted a regulation revoking all such opinions. 21 C.F. R. § 310.100(d). Thereafter virtually all prescription drug products which had come on the market since 1938 would be regarded as a new drug requiring either a full or, in certain narrowly defined cases, an abbreviated new drug application (ANDA).
In 1976 the FDA published a Compliance Policy Guide (CPG) which established enforcement priorities for proceedings against DESI-related drugs that were being marketed without approved applications. The sixth category included unapproved combination drugs that are related to drugs which had been found effective in the DESI program.
As noted above before a product can be exempted from the statutory, new drug preclearance procedures, it must be "generally recognized" by qualified experts as safe and effective for its intended uses. 21 U.S.C. § 321(p). The "general recognition" requirement does not involve the actual safety or effectiveness of the product. Rather, it is the product's reputation in the scientific community that is relevant. Further, the experts' opinion as to general recognition must be based upon well-controlled, clinical studies which are published; the opinions of experts may not be based upon uncontrolled data or upon their own personal experiences. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 619, 93 S.Ct. 2469, 2478, 37 L.Ed.2d 207 (1973). The general recognition of a product's safety and effectiveness must be documented by at least the same quality and quantum of evidence that would suffice to obtain FDA's approval of the product in the first instance. Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 652, 93 S.Ct. 2488, 2493, 37 L.Ed.2d 235 (1973).
Certain FDA regulations are particularly pertinent to the present case. One is contained in 21 C.F.R. § 314.126. It sets forth in considerable detail the essential components of an adequate and well-controlled investigation. A study must meet these criteria in order to constitute substantial evidence of a product's effectiveness. Weinberger v. Hynson, Westcott & Dunning, Inc., supra, 412 U.S. at 617-20, 93 S.Ct. at 2477-78; Cooper Laboratories, Inc. v. FDA, 501 F.2d 772 (D.C.Cir.1974).
Another particularly pertinent regulation is set forth in 21 C.F.R. § 300.50 and provides in part:
(a) Two or more drugs may be combined in a single dosage form...
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