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Rhone-Poulenc, Inc., Hess & Clark Div. v. Food & Drug Admin.

Citation: 11 ELR 20457
No. Nos. 79-1694, -1706, 636 F.2d 750/(D.C. Cir., 11/24/1980)

The court rules that the Commissioner of the Food and Drug Administration (FDA) acted properly in banning the use of diethylstilbestrol (DES) as an animal drug and in declining to prepare an environmental impact statement (EIS) prior to the ban. The Commissioner had withdrawn his approval of DES, as required by § 512 of the Federal Food, Drug, and Cosmetic Act, based on new evidence that the drug was not safe for use under the conditions as originally approved. The court first rules that the Commissioner provided substantial evidence that DES was present in the edible portions of animals in sufficient quantities to meet the "new evidence" standard of § 505(h) of the Food and Drug Act, which would allow the FDA to reconsider its approval. Second, FDA studies, which concluded that it is impossible to determine a safe level of DES in humans, provided sufficient evidence to shift the burden of showing the safety of DES to the manufacturers. Third, the court affirms the Commissioner's finding that defendants have not shown that the benefits of DES outweigh the risks associated with its continued use as an animal drug. Finally, the court agrees that banning DES would not significantly affect the quality of the human environment; thus an EIS is not required under the National Environmental Policy Act.

The full text of this opinion is available from ELR (6 pp. $1.25, ELR Order No. C-1240.

Counsel for Petitioners
Eugene I. Lambert, Richard F. Kingham
Covington & Burling
888 16th St. NW, Washington DC 20006
(202) 452-6000

Frederick S. Hird Jr., James L. Kaler
Kaler, Worsley, Daniel & Hollman
710 Ring Bldg., 1200 18th St. NW, Washington DC 20036
(202) 331-9100

Counsel for Respondents
Donald O. Beers, Robert M. Spiller Jr.; Richard M. Cooper, Chief Counsel for Enforcement
Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857
(301) 443-4380

Robert B. Nicholson, Susan J. Atkinson
Antitrust Division
Department of Justice, Washington DC 20530
(202) 633-2489

Per curiam

[OPINION OMITTED BY PUBLISHER IN ORIGINAL SOURCE]