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July 16, 1975

UNITED STATES of America, Plaintiff,
An ARTICLE OF DRUG consisting of 2,000 cartons, more or less, each containing 2 empty vials and 2 bottles of liquid, and 1 insert, labeled in part: "Poison OVA II Contains Hydrochloric Acid. Use Solution only as directed. * * * First Aid * * * Mfg. for Faraday Laboratories * * *", etc., Faraday Laboratories, Inc., Claimant

The opinion of the court was delivered by: BIUNNO

BIUNNO, District Judge.

 This case involves the question whether a kit of chemicals and equipment, marketed in interstate commerce by Faraday Laboratories, Inc. under the name "OVA II", is a "drug" within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq.

 The United States (FDA) filed a complaint for forfeiture and condemnation of several thousand kits seized within the jurisdiction of the court 21 U.S.C. § 331, and Faraday, as claimant, resists that action.

 Based on discovery materials, both sides had moved for summary judgment and both motions were denied because of a number of uncertainties as to both law and facts precluding summary judgment. Opinion and Order dated April 10, 1974.

 By supplemental memorandum dated April 19, 1974, the court posed a series of inquiries to explore the question whether the matter could be dealt with on cross-motions for summary judgment. The parties have since submitted a detailed "Joint Response" which, for the most part embodies answers that both sides agree on, and for a few sets out areas of disagreement, with the posture on each side explained, these being mainly in areas of interpretation rather than matters of fact. The questions raised and the responses given are illuminating.

 Both parties have now renewed their motions for summary judgment and have submitted argument in light of the Joint Response.

 The major difficulty in reaching a decision on the motions arises from the phrasing of the statutory provisions involved. The statutory definition of a "drug", for this purpose, set out in 21 U.S.C. § 321(g)(1), makes use of ordinary words of the language in such peculiar and special senses as to make interpretation an uncertain task.

 Three alternative definitions are involved here:

 A. "Articles" recognized in the official United States Pharmacopeia, and other identified compendia, are "drugs";

 B. "Articles" intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals are "drugs";

 C. "Articles" intended to affect the structure or any function of the body of man or other animals are "drugs".

 FDA claims that the Ova II kit falls within all three definitions. Faraday claims that it falls within none. Both sides agree that if it comes within any of the definitions of a "drug", it is also a "new drug" as defined by 21 U.S.C. § 321(p), and may not be marketed in interstate commerce without first filing a "new drug application" on the basis of which FDA determines that it is "safe and effective", 21 U.S.C. § 355.

 It should be observed in passing and for context that historically, a dispute on the question whether something is "safe and effective" was normally resolved on the basis of expert testimony adduced in the course of the litigation. Under the present scheme, that method is excluded and two new alternative methods are provided. One, if the item is one which has recognition in the technical and professional literature, in the form of papers by investigators competent in the field, it is accepted as being an "old drug" which may be marketed in interstate commerce without further proof that it is "safe and effective."

 Two, if the item has no such body of published literature to support the proposition that it is "safe and effective", there must first be an administrative determination by FDA, as the disposition of a new drug application, that it is "safe and effective".

 The term "safe" and "effective", in some contexts, may be more or less absolute terms. Most people think of something as being "safe" when its use or application under any conceivable set of circumstances is not likely to cause some kind of harm or damage. They will think of something as being "effective" when its use or application invariably achieve the desired result.

 Thus, everyone knows that plain water may be thought of as being safe and effective for the removal of a stain of cherry-colored sugar syrup from fabric. This will be true if the fabric is ordinary cotton, or linen, or polyester and the like. But if the fabric contains a "filler", or is colored with a water-soluble dye, the use of water may damage the fabric while removing the stain. In those conditions, while effective, the use of plain water will not be safe.

 Similarly, in cases where water will not harm the fabric, it will not be effective if the stain contains oil or grease. For them, a solvent such as alcohol, kerosene or benzene may be needed. These may be effective, but because they give off flammable fumes, care must be taken in using them. Oxalic acid is effective for the removal of rust stains, but it is a poison and must be used with great care. Are these products "safe"? Under what conditions?

 Thus, it is plain that the terms are relative and not absolute. and a designation that something is "safe" or "effective" involves collateral questions such as "to whom or what", and "for what purpose", and "compared to what"?

 The court is not called upon in this case, whether decided on the motions or by trial, to decide whether Ova II is "safe and effective". But the brief evaluation of these terms is important as context because it is plain that the underlying purpose of the Act is to limit interstate commerce in "drugs" to those that are "safe and effective", either because they are old drugs whose qualities are regarded as established by the published literature or because they are new drugs whose qualities in that regard are passed on by FDA as the culmination of a new drug application.

 This context is of assistance in determining the proper boundaries of the term "drug" in the peculiar and artificial sense employed in the definition of the term.

 It should also be observed that the Food, Drug and Cosmetic Act (FCDA), does not purport to encompass the entire federal field. Other acts dealing with one or another aspect of the entire subject include:

Public Health Service Act, 42 U.S.C. § 262;
Controlled Substances Act, 21 U.S.C. § 801 et seq. ;
Controlled Substances Import and Export Act, 21 U.S.C. § 951 et seq. ;
Narcotic Addict Rehabilitation Act, 42 U.S.C. § 3401 et seq. ;
Hazardous Substances Act, 15 U.S.C. § 1261 et seq. ;
Fair Packaging and Labeling Act, 15 U.S.C. § 1451, et seq. ;
Poison Prevention Packaging Act, 15 U.S.C. § 1471 et seq. ;
Caustic Poison Act, 15 U.S.C. § 401, et seq. ;
Federal Trade Commission Act, 15 U.S.C. § 45.

 The parties agree that these acts, as well as the FDCA, generally derive their authority from the commerce clause of the U.S. Constitution, Art. I, § 8.

 It is also agreed that regulation of the practice of the health professions, such as medicine, veterinary medicine, dentistry, pharmacy, nursing, and the like, is predominantly dealt with by state law rather than federal law, even though some aspects of the practice may involve compliance with one or another federal law. Most states also have laws in regard to food and drugs as well as water supply, sewage and garbage disposal, sanitation, quarantine and other matters of concern from a public health standpoint.

 The major division of jurisdiction is plainly on the basis of whether the subject-matter is intrastate or interstate, except only as the state are authorized, without the consent of Congress, to levy imports or duties on imports or exports to the extent absolutely necessary for executing their inspection laws, U.S. Constitution, Art. I, § 10.

 This test is in glass, outside the body, using body fluids available by ordinary bodily processes (i.e., " in vitro." to use the technical term). The test does not involve the injection or ingestion of any material in the human body itself (i.e., " in vivo ").

 Items which are "drugs" as contemplated by the statute fall into two major functional categories. One such category is the "diagnostic" function. The other is the "treatment" function, in the broadest sense that embraces prevention and alleviation of pain or discomfort as well as "cure."

 Those items related to the treatment function are necessarily "in vivo." Something must be done, or applied to or placed within the body itself to provide treatment. At least in this country, treatment outside the body, as by inserting pins in a doll, is not considered to be treatment.

 Those items related to the diagnostic function may be either "in vivo" or "in vitro." The test of a urine sample for the presence of sugar is "in vitro," and is a means for diagnosing the disease of diabetes. The presence of certain enzymes in the blood, with the test performed "in vitro" may indicate heart disease in the form of a myocardial infarction.

 On the other hand, the Schick Test, which involves the intradermal injection of a dilute toxin, is an "in vivo" diagnostic procedure to determine susceptibility or immunity to diphtheria. Similarly, scratch tests which involve the tearing of the skin surface and the application of allergens are another example of "in vivo" diagnostic procedures for allergies and sensitivity to various substances. A gynecological examination is also "in vivo."

 In the ordinary sense of the word "drugs," it would be rational to limit its meaning to items used or applied for diagnostic purposes to those employed "in vivo" and not for those employed "in vitro." There can be little question that for the entire array, this distinction will usually be valid.

 But an overlap between these two areas arises by reason of the decision in U.S. v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 89 S. Ct. 1410, 22 L. Ed. 2d 726 (1969). The item in that case involved a sheet in disc form, on which the manufacturer applied a variety of antibiotic preparations. The intended use was to permit a rapid and essentially simultaneous differentiation of effectiveness of the various antibiotics to treat an infectious disease. In use, a sample of infected material taken from the patient was placed in a petri dish and cultured. The disc-shaped sheet with different antibiotics was then placed in contact with the culture, and the results observed, the index being that the area with the effective antibiotic would turn clear.

 Both the District Court and the Court of Appeals concluded that this testing disc was not a "drug," and hence not a "new drug" requiring a determination that it was safe and effective, as the end result of a new drug application, before it could be marketed in interstate commerce. This result rested largely on the view that the disc was a "device" falling within the statutory exception, 21 U.S.C. § 321(g)(1) and, (h) to the otherwise broader definition of a "drug."

 The Supreme Court reversed and held that the disc was a "drug." Careful analysis of all the opinions in the case indicates that this conclusion reached to the outer boundaries of what might be found to be encompassed by the definition "drug." The fundamental rationale of the conclusion rests on the context within which the disc was used. The activating circumstances would necessarily involve the existence of a patient known to be ill, i.e., suffering from a disease, and that an infection was involved. Also involved is the circumstance that the identity of the infecting organism was not known. Without an item like the disc, a treating physician might be obliged to try one antibiotic after another, by way of "challenge and response" to find out what treatment would be ...

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