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June 13, 1985


Thomas F. Hogan, U.S. District Judge.

The opinion of the court was delivered by: HOGAN

Thomas F. Hogan, U.S. District Judge


 Plaintiff, pro se, has applied to this Court for relief from economic injuries allegedly caused by the actions of the defendant, Food and Drug Administration (FDA). It appears that Mr. Farquhar has developed a topical antimicrobial product for use on intact skin *fn1" that he believes to be a safe and effective product for certain uses, such as a surgical scrub. Mr. Farquhar's complaint arises from what he believes to be the unfair treatment he received at the hands of the FDA. To understand the issues at hand in the cross-motions for summary judgment presently before the Court it is necessary to examine Mr. Farquhar's administrative actions in light of the procedural requirements of the FDA.


 On April 3, 1983, plaintiff submitted a citizen's petition to the FDA requesting that the agency "reopen" the rulemaking record for over-the-counter (OTC) topical antimicrobial drugs in order that the defendant might grant "approval" of the combination of ingredients in plaintiff's newly developed product. See 21 C.F.R. § 10.30. Because of the "undue delay" in receiving a response, plaintiff filed the original complaint asking this Court to compel the FDA to act. A short time later, in July, 1984, the FDA denied plaintiff's petition, explaining that because plaintiff's compound was a "new drug" it could not appropriately be considered in the ongoing OTC antimicrobial product review. *fn2"

 Plaintiff subsequently amended his complaint several times, without objection from the defendant, to revise his claims against the FDA. While plaintiff has not been precise in his allegations of error, the Court has construed the amended complaints, as set forth below, in an effort to fit Mr. Farquhar's allegations within the recognized form of actions against a federal agency. *fn3"

 Mr. Farquhar's arguments in the pleadings before this Court are largely scientific in nature; that is, his memoranda and attachments focus, for the most part, on proving that his drug is "safe and effective" and that the FDA erred in not granting approval for its OTC sale. Plaintiff has phrased his argument in various ways. In essence, it is either a claim for review of the administrative action in denying the reopening of the rulemaking procedure or a request for a declaratory judgment that the agency erred in not finding plaintiff's product to be safe and effective and appropriate for the indicated uses.


 The rulemaking which plaintiff sought to have reopened is part of the FDA's ongoing retrospective review of approved OTC drugs. See Cutler v. Kennedy, 475 F. Supp. 838, 843 (D.D.C. 1979). Unfortunately, it is not the procedure that plaintiff should have followed in order to have his "new drug" approved. In short, the FDA correctly denied plaintiff's petition on the ground that the product in question was a "new drug" for which an approved new drug application must be filed. 21 U.S.C. § 321(p); 21 U.S.C. § 355.

 The Federal Food, Drug & Cosmetic Act defines a "new drug" as a drug that has either: 1) not been generally recognized by qualified experts as safe and effective "for use under the conditions prescribed, recommended, or suggested in the labeling thereof," or 2) not been used to a "material extent for a material time" under such conditions. 21 U.S.C. § 321(p).

 In the case of plaintiff's product, neither the individual chemical ingredients nor the combination had ever been marketed for uses for which plaintiff proposed. *fn4" Letter from William Randolph, Acting Assoc. Commissioner for Regulatory Affairs to George Farquhar (July 27, 1984). Thus, even if plaintiff's product is in fact as safe and effective as plaintiff claims, the absence of marketing data ("to a material extent for a material time") required the FDA to treat plaintiff's product as a "new drug." Plaintiff's attempt to have his product included in the OTC review was therefore inappropriate, and the FDA was justified in requiring plaintiff to proceed through a new drug application. See United States v. Articles of Drug . . . Hormonin, 498 F. Supp. 424, 430-31 (D.N.J. 1980).


 In what the Court must assume was a strategic response to defendant's position as set forth above, plaintiff has repeatedly amended his complaint in an effort to avoid the conclusion that his product requires new drug licensing. In its latest (fourth) incarnation, plaintiff seeks a declaratory judgment that his product is not a "new drug" when used as a sanitizing agent for food handlers.5

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