UNITED STATES SUPREME COURT DECISIONS ON-LINE

Petitioner sells drug products containing citrus bioflavonoid, an extract from fruit skins, as a principal active ingredient. In the 1950's new drug applications (NDA's) were filed and became effective for seven products, and two were sold without any NDA. After the enactment of the 1962 amendments to the Federal Food, Drug, and Cosmetic Act, these products, together with a large number of other bioflavonoid products were examined by the Food and Drug Administration (FDA) for effectiveness. Based upon National Academy of Sciences-National Research Council (NAS-NRC) reports and its own evaluation, FDA gave notice of opportunity for hearing on its proposal to withdraw approvals of NDA's for all drugs containing these compounds, alone or in combination with other drugs. Petitioner then brought suit in the District Court, seeking a declaratory judgment that its drugs are exempt from the efficacy requirements under § 107(c)(4), the so-called "grandfather" clause. FDA refused a stay pending the judicial proceedings and went forward with its administrative action. Petitioner submitted no evidence of "adequate and well controlled investigations," as required by § 505(d) to support its claims of effectiveness, and FDA withdrew petitioner's NDA's. Section 107(c)(4) exempts from the effectiveness requirements any drug which, on the day preceding the 1962 enactment, (1) was commercially used or sold in the United States, (2) was not a "new drug" as defined in the 1938 Act, and (3) "was not covered by an effective application" for a new drug under the 1938 Act. The District Court found that two of the products had never been covered by effective NDA's and that, while seven had been covered, their applications had later been withdrawn by petitioner. It concluded that petitioner's drugs were not covered by effective applications, and hence were exempt from the effectiveness criterion. The Court of Appeals reversed on the merits. It held that petitioner's drugs were not entitled to an exemption, that an applicant could not withdraw an NDA once clubjuris

Page 412 U. S. 656

it became effective, that the drugs were "covered by an effective application," and that, although "me-too" drugs (similar drugs) of other manufacturers would be exempt, petitioner's "me-too's" were not exempt.

Held:

1. "Any drug" is used in § 107(c)(4) in the generic sense, which means that the "me-too's," whether the products of the same or of different manufacturers "covered" by an "effective" NDA, are not exempt from the efficacy requirement of § 201(p). Pp. 412 U. S. 663-665.

2. Prescription drugs on the market are subject to the 1962 efficacy requirements, for if the 1962 amendments are to be comprehensively meaningful, § 107(c)(4) cannot be read so as to provide a loophole to permit the marketing of drugs previously subject to new drug regulation without demonstrating by the new statutory standards that they have the claimed efficacy. Pp. 412 U. S. 665-666.

3. The congressional purpose was to exempt only those drugs that never had been subject to the new drug regulation, and therefore any drug for which an NDA had once been effective does not fall within the exempt category. Pp. 412 U. S. 666-668.

461 F.2d 223, affirmed.

DOUGLAS, J., delivered the opinion of the Court, in which all Members joined, except BRENNAN, J., who took no part in the consideration or decision of the case, and STEWART, J., who took no part in the decision of the case. clubjuris

Page 412 U. S. 657