Takhar v. Kessler

• Decision Date: 12 February 1996
• Docket Number: No. 94-15605,94-15605
• Citation: 76 F.3d 995
• Parties: 96 Cal. Daily Op. Serv. 967, 96 Daily Journal D.A.R. 1588 Santokh TAKHAR, D.V.M., Plaintiff-Appellant, v. David A. KESSLER, M.D., individually and in his capacity as Commissioner of Food and Drug, Department of Health and Human Services, et al., Defendants-Appellees.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 995

76 F.3d 995

96 Cal. Daily Op. Serv. 967, 96 Daily Journal

D.A.R. 1588

Santokh TAKHAR, D.V.M., Plaintiff-Appellant, v. David A. KESSLER, M.D., individually and in his capacity as

Commissioner of Food and Drug, Department of

Health and Human Services, et al.,

Defendants-Appellees.

No. 94-15605.

United States Court of Appeals, Ninth Circuit.

Argued and Submitted October 19, 1995.

Decided Feb. 12, 1996.

George A. McKray, San Francisco, California, for plaintiff-appellant.

Patricia J. Kenney, Assistant United States Attorney, San Francisco, California, for defendants-appellees.

Appeal from the United States District Court for the Northern District of California; Charles A. Legge, District Judge, Presiding.

Before: SCHROEDER, FLETCHER and RYMER, Circuit Judges.

OPINION

FLETCHER, Circuit Judge:

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.

BACKGROUND

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. ¹ 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 prescribing veterinarian.

CPG 7125.06, July 20, 1992.

In addition, the FDA indicated that certain drugs could not be used in food-producing animals even when the outlined criteria and precautions were met and followed. The 1984 CPG specified that such drugs included chloramphenicol and DES, and the 1992 version of CPG 7125.06 lists use of seven additional types of drugs in food-producing animals as among the highest-priority extra-label drug uses for regulatory attention. With respect to chloramphenicol, the FDA went further and in 1986 withdrew approval of chloramphenicol oral solution for animal use. 50 Fed.Reg. 27,059 (July 1, 1985) (notice of proposed regulation); 51 Fed.Reg. 1,367 (final rule withdrawing approvals).

In 1991, the FDA issued CPG 7125.35 regarding the use of human drugs in animal medicine. ² The agency noted that most such use occurs in non-food pets and that "[m]any of the maladies of pets cannot be treated in accordance with current standards of veterinary practice without the use of human drugs since veterinary versions of many human drugs do not exist". CPG 7125.35, March 19, 1991. Concern was expressed about increasing promotion and distribution of human drugs for use in, and actual use of such drugs in, food-producing animals. The criteria and precautions in CPG 7125.06 for extra-label animal-drug use in food-producing animals were incorporated by reference to guide enforcement of extra-label human-drug use in such animals, and the FDA announced its intent to take aggressive regulatory action to discourage such use, while stating that extra-label human-drug use in non-food-producing animals would not ordinarily prompt regulatory action. The current version of CPG 7125.35 specifies that food-animal veterinarians should consider extra-label human-drug use only when:

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; and

3) adequate steps are taken to prevent illegal residues from occurring in food.

CPG 7125.35, July 20, 1992. Even when these criteria and precautions are met and followed, the agency stated that it would consider regulatory action if an illegal residue occurred in food because of the extra-label drug use.

On October 22, 1994, after briefing in this case but before oral argument, the Animal Medicinal Drug Use Clarification Act of 1994 became law. Pub.L. No. 103-396, 1994 U.S.C.C.A.N. (108 Stat.) 4153. The Act amended the FDCA to allow extra-label use of approved drugs in the practice of veterinary medicine in accordance with regulations to be promulgated by the Secretary of Health and Human Services. The Act's amendments to the FDCA will take effect when the Secretary adopts final regulations, which are due by October 22, 1996 but which have not yet been proposed.

B. Takhar's Prior Conviction

In June 1986, Takhar was indicted on one count each of misbranding and adulterating new animal drugs in violation of 21 U.S.C. §§ 331(k) and 333(a); his veterinary partner, Wesley A. Jacobs, was indicted for the same violations as well as for one count of making false statements to an FDA investigator in violation of 18 U.S.C. § 1001. The indictments were based on 1984 investigations by the FDA into the purchase and use of chloramphenicol in Takhar's and Jacobs' practices. The indictments were dismissed by the district court for prosecutorial misconduct; the government appealed to this court, which reversed and remanded the case with instructions that it be reassigned. United States v. Jacobs, 855 F.2d 652 (9th Cir.1988).

On remand, in January 1989, the judge to whom the case had been reassigned denied Takhar's Motion to Dismiss Indictment in Part, in which Takhar asserted that as a licensed veterinarian he was exempt under 21 U.S.C. §§ 353(b)(2) and 360(g)(2) from certain registration, labelling, and prescription requirements, and that the FDA had banned the use of chloramphenicol in food-producing animals without proper notice or opportunity to comment. In October 1989 Takhar pled guilty to one count of misbranding new animal drugs and was sentenced to three years probation, 300 hours of community service, and a $1,000 fine. An Order Terminating Term of Supervised Release/Probation Prior to Expiration Date was entered on July 12, 1991.

C. Proceedings Below

On July 16, 1993, Takhar filed a Complaint for Declaratory Judgment and Injunctive Relief against FDA officials, including David Kessler, M.D. and Gerald Guest, D.V.M. ³ Takhar asked the court (1) to declare that licensed veterinarians are exempt from certain registration, labelling, and prescription requirements under 21 U.S.C. §§ 360(g)(2) and 353(f) when using prescription drugs solely in the course of their professional practices; (2) to declare that the FDA lacked the authority to prosecute veterinarians for violating provisions of the CPGs regarding specific drugs because the agency failed to follow notice-and-comment procedures in promulgating the CPGs; and (3) to enjoin the FDA from enforcing CPG 7125.35 in violation of the alleged practice-of-medicine exemption. On September 14, 1993, the defendants moved to dismiss the complaint for lack of subject-matter jurisdiction and failure to state a claim; on October 22 the district court dismissed the complaint, with leave to amend, for lack of subject-matter jurisdiction. On November 29, Takhar filed a First Amended Complaint seeking similar relief. On December 10, the defendants moved again to dismiss for lack of subject-matter jurisdiction and failure to state a claim. After a hearing in January 1994, the district court dismissed the...