ELR Citation: ELR 20147
No(s). 73-1581 (D.C. Cir. Jan 24, 1974)

Two orders of the Commissioner of the Food and Drug Administration (FDA), which withdrew approval of New Animal Drug Applications for implant pellets of the growth hormone DES and revoked certain regulations governing their use, are held illegal and vacated by the U.S. Court of Appeals for the D.C. Circuit. The court rules that the Commissioner's summary disposition of the withdrawal question illegally deprived the petitioner of the opportunity for a hearing, since the two prior notices given by the FDA were ambiguous as to what action was being considered and did not establish a prima facie case for withdrawal without a hearing. New data, which showed DES residues in beef liver and upon which withdrawal was based, did not become a available to the FDA until after publication of these notices, and petitioners were never accorded the opportunity to evaluate these facts and respond to them by pointing out any material issues which might serve as the basis for a hearing. The court emphasizes that since the DES residues were found by a test method not yet approved by the agency, the withdrawal action cannot be based on the Delaney Clause which prohibits the presence of any residue of a carcinogenic drug in edible portions of slaughtered animals. The agency's action must be based instead on the general safety clause, which permits withdrawal if new evidence shows that DES is not shown to be safe for use. The court then finds that the FDA has not investigated sufficiently the relationship between these detected residues and safety, and has not balanced any possible risks to health against the hormone's acknowledged benefits for meat production. In view of these omissions, the agency's attempt to shift to the petitioner the affirmative burden of proving the safety of DES implants in order to receive a hearing must fail. The case is remanded to the agency for further proceedings consistent with the court's opinion, and pending those proceedings petitioner may market DES implants.

Counsel for Petitioner
Eugene I. Lambert
Covington & Burling
888 16th Street NW
Washington, DC 20006

James L. Kaler
Frederick S. Hird, Jr.
Kaler, Worsley, Daniel & Hollman
710 Ring Building
Washington, DC 20036

Counsel for Respondents
Alvin L. Gottlieb Deputy Asst. General Counsel
Joanne S. Sisk Chief, Appellate and Special Proceedings Branch
Robert M. Spiller, Jr.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852

Howard S. Epstein
Department of Justice
Washington, DC 20530