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AMERICAN PUB. HEALTH ASSN. v. VENEMAN

August 23, 1972

AMERICAN PUBLIC HEALTH ASSOCIATION and National Council of Senior Citizens, Plaintiffs,
v.
John G. VENEMAN, Acting Secretary of the Department of Health, Education and Welfare, and Charles Edwards, Commissioner of the Food and Drug Administration, Defendants


Bryant, District Judge.


The opinion of the court was delivered by: BRYANT

BRYANT, District Judge.

 I

 Before the court are the cross-motions of the parties for summary judgment. Because of the complex nature of this case, a detailed recitation of the facts is appropriate.

 In 1962, the Congress amended the Food, Drug, and Cosmetic Act of 1938 to require that all drugs on the market be proven effective for their suggested use. *fn1" Under 21 U.S.C. § 355(e) (1970),

 
The Secretary shall, after due notice and opportunity for a hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds . . . (3) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence 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 thereof. . . .

 Section 355 relates solely to non-antibiotic drugs. Under § 357(h), antibiotic drugs may be ordered withdrawn when

 
(2) the Secretary finds, on the basis of new information with respect to such drug evaluated together with the information before him when the application under section 355 of this title became effective or was approved, that there is a lack of substantial evidence (as defined in section 355(d) of this title) that the drug has the effect it purports or is represented to have under such conditions of use.

 The term "substantial evidence," as used in §§ 355(e) and 357(h) means

 
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. § 355(d) (1970).

 Under the terms of P.L. 87-781, Section 107(c)(3)(B), the effectiveness requirement did not take effect until October 10, 1964, two years after enactment of the statute. The Food and Drug Administration in 1964 promulgated regulations to require the drug manufacturers to report whether approved drugs were still being marketed in conformity with the conditions for which they had been approved and to submit scientific data in support of any claims in promotional material which departed from the approved labeling. The drug industry failed to comply, and litigation instituted in the District of Delaware by the Pharmaceutical Manufacturers Association challenging the legality of the regulation was still pending as of September 3, 1970. *fn2"

 In 1966, Dr. James Goddard became Commissioner of the FDA and began to move ahead with efficacy studies of the various drugs. In July of 1966, a contract with the National Academy of Sciences-National Research Council was signed, whereby the NAS-NRC was to review the efficacy of all drugs which had been given FDA approval from 1938 to 1962. The FDA then published orders in the Federal Register requiring the drug manufacturers to submit certain information regarding each approved drug, including references to evaluations of the effectiveness of the drug. The purpose was to permit the manufacturers the "opportunity to identify the best available evidence which they believed supported the claims made for the drug." *fn3" After several extensions, the manufacturers were required to submit their information by July 1, 1967. *fn4" NAS-NRC began submitting its first reports on October 11, 1967, and submitted the last report on April 15, 1969; there were 2,824 reports submitted, covering approximately 3,700 drugs manufactured by 237 companies.

 In January, 1968, the FDA began implementation of the NAS-NRC reports. The procedure adopted has been to evaluate each report and to release it to the public only after the FDA evaluation is completed. When the FDA completes its evaluation of an NAS-NRC report, an announcement is made in the Federal Register that the FDA has concluded that the drugs involved are "effective," "probably effective," "possibly effective," or "lack substantial evidence of effectiveness"; the first three classifications are the same as those used in the NAS-NRC reports, but the last seems to be an FDA substitution for the NAS-NRC classification "ineffective."

 After announcing the classification of a drug in the Federal Register, the FDA affords the drug manufacturer a period of time to provide additional data to the FDA in every case where the drug is classified as anything other than "effective." The manufacturer is given 12 months or 6 months where the drug is listed as probably or possibly effective, respectively, *fn5" and 30 days where the drug is classified as lacking substantial evidence of effectiveness. *fn6" During this time period, the manufacturer is permitted to continue marketing the drug. If, at the end of the interim period, no studies have been undertaken by the manufacturer, or if the studies do not provide ...


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