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United States v. Article of Drug . . . Ova II

District Court, D. New Jersey
1975 U.S. Dist. LEXIS 11424, 414 F. Supp. 660 (1975)
ELI5:

Rule of Law:

An in vitro diagnostic kit is not a "drug" under the Federal Food, Drug, and Cosmetic Act if it is not used to diagnose a disease, does not affect the body's structure or function, and contains chemicals not specifically marketed for medicinal use.


Facts:

  • Faraday Laboratories manufactured and marketed a product called "OVA II" in interstate commerce.
  • The product was sold as a kit intended for use in the home.
  • The kit's purpose was to perform a preliminary screening test to indicate the probability of pregnancy.
  • The kit contained two glass vials and two bottles of solutions: hydrochloric acid (HCl) and sodium hydroxide (NaOH).
  • To use the kit, a woman would add fresh urine to the vials and react it with the chemical solutions.
  • The user would observe visual color differences in the mixture to determine the result.
  • The entire testing process occurred in vitro (within the glass vials), outside the human body.
  • No materials from the kit were ingested, injected, or applied to the user's body.

Procedural Posture:

  • The United States (FDA) filed a complaint for forfeiture and condemnation of the OVA II kits in the U.S. District Court for the District of New Jersey.
  • Faraday Laboratories intervened as the claimant to resist the seizure.
  • Both parties moved for summary judgment.
  • The District Court denied the initial motions due to uncertainties regarding law and facts.
  • The parties submitted a "Joint Response" clarifying the facts and disputes.
  • Both parties renewed their motions for summary judgment before the District Court.

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Issue:

Is an in vitro home pregnancy test kit containing chemical reagents considered a "drug" subject to FDA regulation under 21 U.S.C. § 321(g)(1)?


Opinions:

Majority - Biunno

No, the kit is not a drug because it fails to meet any of the three statutory definitions provided by the FDCA. First, regarding the definition of articles recognized in the U.S. Pharmacopeia (USP): although the kit's chemicals (HCl and NaOH) are listed in the USP, they are not "drugs" unless intended for medicinal use. Common substances like water and salt are in the USP, but are not drugs in every context. Since these chemicals were not labeled "U.S.P." or sold for medicinal application, this definition does not apply. Second, regarding the diagnosis of disease: the court determined that pregnancy is a normal physiological function, not a disease. Therefore, a test providing "news" of pregnancy is not diagnosing an illness. This distinguishes the case from Supreme Court precedent in Bacto-Unidisk, where antibiotic sensitivity discs were deemed drugs because they were essential to treating specific infections. Third, regarding articles intended to affect the structure or function of the body: this definition implies in vivo application. Because the OVA II test is performed entirely in vitro and never enters the body, it cannot affect bodily structure or function.



Analysis:

This decision places significant limitations on the FDA's regulatory reach regarding diagnostic products prior to the full implementation of Medical Device Amendments. The court utilized a "common sense" approach to statutory interpretation, particularly in its refusal to classify pregnancy as a disease. The ruling clarifies that the mere presence of USP-listed chemicals does not automatically categorize a product as a drug; the intended use is paramount. Furthermore, it establishes a clear distinction between in vitro diagnostics for non-disease conditions and in vivo drugs or diagnostics that guide disease treatment.

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