IMS LTD. v. Califano, Civ. No. 77-2552-RJK.

• Decision Date: 28 November 1977
• Docket Number: Civ. No. 77-2552-RJK.
• Court: U.S. District Court — Central District of California
• Parties: IMS LIMITED, d/b/a International Medication Systems Ltd., a corporation of Delaware, Plaintiff, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education and Welfare, and Donald Kennedy, Commissioner of the Food and Drug Administration, Defendants.

453 F. Supp. 157

IMS LIMITED, d/b/a International Medication Systems Ltd., a corporation of Delaware, Plaintiff, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education and Welfare, and Donald Kennedy, Commissioner of the Food and Drug Administration, Defendants.

Civ. No. 77-2552-RJK.

United States District Court, C. D. California.

November 28, 1977.

Joseph E. Mueth, Wills, Green & Mueth Law Corp., Los Angeles, Cal., for plaintiff.

Dzintra I. Janavs, Asst. U. S. Atty., Los Angeles, Cal., for defendants.

MEMORANDUM OF DECISION AND ORDER

KELLEHER, District Judge.

Plaintiff filed a complaint on July 11, 1977, seeking a declaratory judgment that a certain drug (furosemide) is not a "new drug" within the meaning of §§ 201 and 505 of the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 321(p) and 355, so as to require plaintiff to file with and obtain approval of a new drug application (NDA) from the FDA. The complaint also seeks injunctive relief restraining the FDA from proceeding against plaintiff's stocks of furosemide by way of libel and condemnation.

On June 13, 1977, the District Director for the Los Angeles District of the FDA sent plaintiff drug manufacturer a letter which stated that a recent inspection of plaintiff's firm indicated that plaintiff was in violation of § 505 of the Act in that the furosemide plaintiff was found to be importing was a "new drug" as to which plaintiff had failed to file and obtain approval of an NDA. The letter requested plaintiff to contact the FDA within ten days, stating the action plaintiff proposed to take to correct the violation, and threatened the invocation of regulatory sanctions should plaintiff fail to respond.

Apparently plaintiff's response was to file this lawsuit. Plaintiff contends that furosemide is not subject to the § 505 pre-marketing clearance procedures in that it is not a "new drug" within the meaning of § 201(p). The definition of "new drug" specifically exempts any drug which is "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 labelling thereof . .." Plaintiff contends that furosemide is just such a "generally recognized" drug, having been used "routinely" throughout the United States and the world for over ten years and having been recognized as safe and effective by qualified experts.

The basis for the FDA's new drug classification is plaintiff's use of its patented Min-I-Jet delivery system for injecting furosemide in lieu of a glass ampule system utilized by the only other drug manufacturer marketing furosemide in the United States. Under the FDA's regulations:

(h) The newness of a drug may arise by reason (among other reasons) of:

. . . . .

(5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, . . . even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

21 C.F.R. § 310.3(h)(5).

Although plaintiff does not actually cite this regulation, its action must be seen as an attack at least on the FDA's application of this regulation in this instance. Plaintiff claims that since 1969 plaintiff has converted other drugs (sodium bicarbonate and epinephrine) to its Min-I-Jet system, that other such drugs were "generally recognized . . as safe and effective" and thus not "new drugs," that the FDA knew that plaintiff was so doing, and that the FDA neither classified plaintiff's products as "new drugs" nor requested that plaintiff file NDA's. Thus, it is argued, the FDA's present classification is arbitrary or at least inconsistent.

The FDA filed the instant motion to dismiss or, alternatively, for summary judgment on September 12, 1977.

The motion is granted, without prejudice. The basis for this disposition is primary jurisdiction of the FDA to resolve the jurisdictional question (i. e., whether plaintiff's product constitutes a "new drug" requiring filing and approval of an NDA), absence of final agency action so as to permit district court review under the Administrative Procedure Act (APA), 5 U.S.C. §§ 701-704, and failure of plaintiff to exhaust administrative remedies.

The issue of primary jurisdiction to determine the status of a drug product as a "new drug" received the attention of the Supreme Court in 1973 in a series of cases interpreting the 1962 Amendments to the Food, Drug and Cosmetic Act. In Weinberger v. Hynson, Westcott and Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973), petitioner drug companies had argued that while the FDA had jurisdiction to approve, deny, or withdraw previously-approved NDA's, only the district court had jurisdiction to determine whether or not a particular product constituted a "new drug." The Court flatly rejected the contention, holding that the FDA has authority to determine just such an issue. Id. at 624, 93 S.Ct. at 2480. The Court noted that under 5 U.S.C. § 554(e) the FDA had power to issue a declaratory order "to terminate a controversy or remove uncertainty."

If the administrative controls over drugs are to be efficient, they must be exercised with dispatch. Only paralysis would result if case-by-case battles in the courts were the only way to protect the public against unsafe or ineffective drugs.

Id. at 626, 93 S.Ct. at 2481.

Noting that "the heart of the new procedures designed by Congress is the grant of primary jurisdiction to FDA," the Court observed that judicial relief would be available only after administrative remedies had been exhausted. Id. at 627, 93 S.Ct. at 2482.

In Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973), the Court ruled that the parties could not confer jurisdiction upon the district court to determine "new drug" status,...