U.S. v. Articles of Drug, 86-1238
| Decision Date | 01 September 1987 |
| Docket Number | No. 86-1238,86-1238 |
| Citation | 826 F.2d 564 |
| Parties | UNITED STATES of America, Plaintiff-Appellee, v. ARTICLES OF DRUG ... Promise Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... Sensodyne-F Toothpaste for Sensitive Teeth ... Active Ingredients: Potassium Nitrate, Sodium Monofluorophosphate ... and Block Drug Co., Inc., Leonard N. Block and James A. Block, Defendants-Appellants. |
| Court | U.S. Court of Appeals — Seventh Circuit |
Thomas O. Henteleff, Kleinfeld Kaplan & Becker, Washington, D.C., for defendants-appellants.
Ann H. Wion, Associate Chief Counsel for Enforcement Office of Gen. Counsel Food & Drug Admin., Rockville, Md., Anton R. Valukas, Atty., U.S.Dept. of Justice, Washington, D.C. for plaintiff-appellee.
Appeal from the United States District Court for the Northern District of Illinois, Eastern Division.
Before WOOD, COFFEY and RIPPLE, Circuit Judges.
This is an appeal from an order granting summary judgment in favor of the government in a forfeiture action 1 brought against certain quantities of toothpaste manufactured and distributed by the defendants, Block Drug Company, and Leonard and James Block (collectively referred to as Block). The government alleged that the toothpastes were "new drugs," and that, because no approved new drug application (NDA) regarding these articles was on file with the Food & Drug Administration (FDA), they were subject to forfeiture. The district court determined that no genuine issue of material fact existed as to whether the articles were "new drugs" under 21 U.S.C. Sec. 321(p). We affirm the order of the district court.
On January 1, 1983, Block began to market Promise and Sensodyne-F (collectively referred to as Promise). Promise combines sodium monofluorophosphate (sodium MFP) and potassium nitrate. Block's purpose in combining these ingredients was to produce a single toothpaste that provided both protection against cavities (through sodium MFP) and relief from dentin hypersensitivity (through potassium nitrate). In this way, people with sensitive teeth could receive cavity protection and relief from hypersensivity in a single brushing. At the time Block began to market the toothpaste, it had not filed an NDA for the products. Despite warnings from the FDA, Block continued to market the products.
The government brought multiple forfeiture actions against Block to seize and condemn the toothpaste. The government later amended its complaint to seek an injunction preventing Block from making further shipments of the toothpaste. The toothpaste mentioned in the complaint was seized on September 2, 1983. On September 26, 1984, the government filed a motion for summary judgment, or in the alternative, for a preliminary injunction. The district court granted the motion for summary judgment in an order issued November 20, 1985 and amended December 5, 1985. United States v. Articles of Drug ... Promise Toothpaste, 624 F.Supp. 776 (N.D.Ill.1985). On December 16, 1985, the district court declared the articles to be unapproved "new drugs," condemned them to be destroyed, and enjoined Block from further distribution of the toothpaste. R. 77. Block moved for a stay of judgment pending appeal on January 6, 1986. R. 80. On April 25, 1986, the district court granted Block's motion for a stay, "subject to the condition that defendants place appropriate warning labels on the products." Appellee's App. at 85.
Under the Federal Food, Drug, and Cosmetic Act (the Act), a "new drug" may not be introduced into interstate commerce unless an approved NDA is on file with the FDA. 21 U.S.C. Sec. 355(a). A drug is a "new drug" unless its manufacturer demonstrates that it is "generally recognized among experts" to be "safe and effective" for its recommended uses. 21 U.S.C. Sec. 321(p)(1). 2 The safety and effectiveness of the drug must be established by "substantial evidence." Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 629, 93 S.Ct. 2469, 2483, 37 L.Ed.2d 207 (1973). "Substantial evidence" is defined as:
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. Sec. 355(d).
The FDA regulations also establish criteria for determining whether a drug may be marketed over-the-counter (OTC) or must be restricted to use by prescription of a physician. An OTC drug must meet the "new drug" requirements set out in the preceding paragraphs. Additionally, it must meet the labeling requirements of the Act (i.e., it may not be misbranded) 3 and the FDA must find that the drug is safe for OTC use.
In 1972, the FDA established its OTC drug review. 21 C.F.R. Sec. 330.10 sets forth "Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded." A drug so classified may be marketed without prior FDA approval. The OTC review establishes a system of expert panels for each of the various categories of OTC drugs. Under this procedure, a panel solicits information from interested parties and recommends a proposed monograph that states the conditions under which the panel would consider the drugs to be generally recognized as safe and effective and not misbranded. The FDA then reviews the panel's recommendation and publishes an advance notice of proposed rulemaking that allows for public comment. After any new information is considered, the FDA publishes a tentative order establishing the conditions under which a category of OTC drugs is generally recognized as safe and effective and not misbranded. After considering any further comments or objections, the FDA publishes a final monograph.
A "new drug" may be created by combining two or more drugs, neither of which is a new drug. 21 C.F.R. Sec. 310.3(h)(2). Even if the component parts of the new drug may be generally recognized as safe and effective, the combination of those parts may not be safe. There is the possibility that the component drugs, when combined, may have a different effect from that of each component drug individually. See United States v. Articles of Food and Drug ... Coli-Trol 80, 518 F.2d 743, 746 (5th Cir.1975). As the court stated in Coli-Trol 80, "new combinations of well-known drugs constitute new drugs for purposes of the Act exactly because the effects of drugs in combinations are often not the sum of their parts." Id.
An expert panel was convened by the FDA to consider OTC dentifrices and dental care drug products that were generally recognized as safe and effective for preventing cavities. This panel classified sodium MFP as generally recognized as safe and effective. 45 Fed.Reg. 20,683-84 (1980). The panel also recommended that certain laboratory testing profiles could be used, as opposed to further clinical investigations, to determine the safety and effectiveness of approved anticaries products. Id. at 20,677-78. However, the panel's recommendations were limited to "single active ingredient" anticaries products. Id. at 20,673-74. It recommended that products combining an anticaries agent such as sodium MFP with another active ingredient be considered new drugs and be required to submit NDAs. Id. 4
In May 1982, the panel issued a proposed monograph for products for the relief of oral discomfort. 47 Fed.Reg. 22,712 (1982). The panel recommended that potassium nitrate should be considered safe in certain dosages but found that there was insufficient data regarding its effectiveness as a desensitizing agent. 47 Fed.Reg. 22,754-55. The panel also recommended that certain combinations of active ingredients for the relief of oral discomfort be allowed. None of these was a sodium MFP/potassium nitrate combination. Id. at 22,719-23. Finally, the panel recommended that sodium MFP be considered safe as a desensitizing agent, but as with potassium nitrate, the panel found that there was insufficient data to establish its effectiveness. Id. at 22,751-53.
The proposed monograph for oral discomfort, published in May 1982, was based on pre-1979 data. During the comment period, both Block and Richardson-Vicks, another drug manufacturer, submitted post-1978 data on the effectiveness of potassium nitrate as a desensitizing agent. 5 Block also submitted data regarding the sodium MFP/potassium nitrate combination. This information was described by the district court as follows:
On October 18, 1982, Block also filed data on the safety and effectiveness of its MFP/potassium nitrate combination. This data contained no clinical testing of the combination, but discussed the rationale for the combination, toxicology data, fluoride bioavailability to demonstrate anticaries effectiveness, and nitrate bioavailability to demonstrate desensitizing effectiveness. On April 25, 1983, after it had begun marketing the drug, Block submitted additional fluoride bioavailability tests and animal anticaries studies, 4- and 8-week human safety studies, and the results of several clinical studies on potassium nitrate previously submitted by Richardson-Vicks.
On September 7, 1983, Block submitted the results of a recently completed 12-week clinical investigation (hereafter "Silverman study"), which tested a 5% potassium nitrate toothpaste (Vick's "Denquel"), a Block sodium MFP/potassium nitrate toothpaste, and a placebo...
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