Appeal from the United States District Court for the Northern District of California. D.C. No. CV-93-02689-CAL. Charles A. Legge, District Judge, Presiding.
Before: Mary M. Schroeder, Betty B. Fletcher, and Pamela Ann Rymer, Circuit Judges. Opinion by Judge Fletcher.
Santokh Takhar, a California-licensed veterinarian with a large-animal practice, challenges two Food and Drug Administration (FDA) Compliance Policy Guides (CPG) as exceeding the agency's statutory mandate by regulating veterinarians' extra-label drug use. He claims they contravene Congressional intent to exempt the practice of veterinary medicine from the Food, Drug and Cosmetic Act (FDCA). He also challenges the CPGs as substantive rules that were adopted without the notice-and-comment procedures required by the Administrative Procedure Act. The district court dismissed Takhar's suit for lack of standing and ripeness. We have jurisdiction under 28 U.S.C. § 1291 and affirm.
A. Extra-Label Drug Use in Animals
"Extra-label" drug use consists of using a drug in a manner not indicated on the FDA-approved manufacturer's label; this can include the use of a drug for a condition, in a dosage, or in an animal species for which the drug has not received FDA approval. The plaintiff asserts that extra-label drug use is common in veterinary medicine because no FDA-approved drugs exist for many diseases in many species; about 30,000 drugs have been approved for human use, while only about 2,000 drugs have been approved for animal use.
By at least 1977, the FDA took the position that while extra-label drug use by veterinarians was technically illegal under the FDCA, its Bureau of Veterinary Medicine did not object to such use in non-food-producing animals as long as the veterinarian legally obtained the drug and had no approved alternative drug available, and as long as the use posed no obvious hazard to the animal's health. CPG 7125.18, September 22, 1977. The FDA stated that extra-label drug use by veterinarians in food-producing animals was not sanctioned and was the responsibility of the veterinarian, and advised that it would take regulatory action where such use resulted in illegal drug residues in edible animal tissue. Id.
In 1984, the FDA revised its compliance policy and issued CPG 7125.06 regarding extra-label use of animal drugs in food-producing animals.*fn1 CPG 7125.06 announced that a finding of illegal drug residues in food would no longer be a prerequisite to regulatory action against extra-label drug use by veterinarians. "Nevertheless," the agency stated, "extra-label drug use in treating food-producing animals may be considered by a veterinarian when the health of animals is immediately threatened and suffering or death would result from failure to treat the affected animals." The agency then provided criteria and precautions for such extra-label drug use and announced that as long as those criteria were met and those precautions followed, the FDA "would not ordinarily" consider regulatory action against veterinarians' extra-label drug use. The current version of those criteria and precautions provides that regulatory action will not ordinarily be considered where:
1) a medical diagnosis is made by an attending veterinarian within a valid veterinarian-client-patient relationship;
2) no approved drug or dosage is available to treat the condition effectively in the animals affected;
3) the animals treated are carefully identified;
4) an extended withdrawal period is assigned and observed before the marketing of food produced by the animal and no illegal residues occur in the food; and
5) the extra-label drug is adequately labelled by the ...