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UNITED STATES v. UNDETERMINED QUANTITIES OF AN ART

August 24, 1987

UNITED STATES OF AMERICA, Plaintiff,
v.
Undetermined Quantities of an article of drug, . . . (Anucort HC Suppositories), Defendants



The opinion of the court was delivered by: SAROKIN

 In this action for seizure and condemnation of a drug, the United States moves for summary judgment.

 BACKGROUND

 "Anucort Hemorrhoidal Suppositories with Hydrocortisone Acetate" (Anucort) is a prescription drug sold to the public for use in treatment of hemorrhoids. G & W Laboratories, claimant herein, began marketing a drug under this label in 1980.

 On November 7, 1985, the United States seized an undetermined quantity of Anucort, pursuant to a complaint of forfeiture. The government's amended complaint, filed November 14, 1985, seeks condemnation of the seized drug on two grounds. First, the government alleges that Anucort is a new drug, as defined by relevant federal statute, that has not been approved by the Federal Drug Administration (FDA). Second, the government alleges that Anucort is a prescription drug under the statute that has been misbranded.

 G & W's answer contains several defenses. First, G & W contends that Anucort is not a new drug and therefore not subject to the required FDA approvals. Second, G & W claims that Anucort is exempted from the new drug approval scheme because it was commercially used and sold prior to the statute's enactment date. Third, G & W contends that the court must remand the matter to the FDA for an initial administrative hearing concerning Anucort's status as a new drug. Fourth, G & W argues that FDA's internal enforcement guidelines preclude this action.

 On June 11, 1986, the government moved for summary judgment. The government also moved before the Hon. Ronald J. Hedges, U.S. Magistrate, for a stay of discovery pending resolution of the summary judgment motion. G & W cross-moved for a continuance of the summary judgment motion pending further discovery. On October 16, 1986, Magistrate Hedges granted the government's motion for a stay of discovery and denied G & W's motion for a continuance.

 G & W appealed the Magistrate's order to this court. On November 24, 1987, at a hearing on the motion, the parties agreed to proceed with the summary judgment motion solely on the ground that Anucort is a new drug because there exists no substantial evidence supporting its safety and efficacy. *fn1"

 On February 17, 1987, the court entered an order that 1) reserved decision on G & W's appeal; 2) stated that plaintiff's summary judgment motion would be directed only to "whether there is a lack of substantial evidence to support a finding that the seized drug is generally recognized as effective as contained in Plaintiff's brief in support of its Motion for Summary Judgment"; 3) stating that the government may rely on only one affidavit, to be submitted, "addressing the existence of relevant studies"; 4) granting G & W the right to submit an opposing affidavit; 5) granting the parties leave to depose the respective affiants.

 On February 11, 1987, the government submitted the affidavit of Dr. C. Carnot Evans. G & W moved to disregard statements in the affidavit, arguing that its contents violated the court's order. The court, by order dated April 20, 1987, reserved decision on G & W's motion pending its ruling on plaintiff's summary judgment motion. The court also granted G & W the right to depose Dr. Evans and two FDA employees who conducted the literature searches mentioned in Dr. Evans' affidavit.

 G & W chose to depose only Mr. Kenter, one of the FDA employees. On May 26, 1987, the court granted G & W's motion to require the government to provide G & W with citations of studies referred to in notes prepared by Mr. Kenter.

 The court now considers plaintiff's motion for summary judgment, as reshaped by this procedural history.

 I. Substantial evidence

 Before the court is the question of "whether there is a lack of substantial evidence to support a finding that the seized drug is generally recognized." Plaintiff, to prevail on its motion for summary judgment, must demonstrate that no genuine issue of material fact exists with respect to this question.

 "Substantial evidence," in this context, means

 
evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.

 21 U.S.C. § 355(d). *fn2"

 At dispute is the nature of the "adequate and well-controlled investigations" required by the above definition. The government contends that § 355(d) requires published studies of the product Anucort itself. G & W contends that studies of other drugs containing the same active ingredient (hydrocortisone acetate) as Anucort constitute substantial evidence under § 355(d). *fn3"

 The court, in evaluating the validity of the FDA's interpretation of § 355, must follow the analysis set forth by the Supreme Court in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984). If the statutory provision unambiguously expresses Congress' intent on the precise question at issue, the court and the agency must follow the plain language; however, if the provision is silent or ambiguous as to the relevant issue, the court must defer to the agency's interpretation as long as that interpretation is reasonable. See id. at 842-44; Young v. Community ...


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