Masti-Kure Products Co., Inc. v. Califano, MASTI-KURE

• Decision Date: 16 June 1978
• Docket Number: MASTI-KURE,No. 76-1146,76-1146
• Parties: PRODUCTS COMPANY, INC., Petitioner, v. Joseph A. CALIFANO, Jr., Secretary of U. S. Department of Health, Education and Welfare, Donald Kennedy, Commissioner of Food and Drugs, Food and Drug Administration and C. D. Van Houweling, Director, Bureau of Veterinary Medicine, Food and Drug Administration, Respondents.
• Court: U.S. Court of Appeals — District of Columbia Circuit

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587 F.2d 1099 190 U.S.App.D.C. 202 MASTI-KURE PRODUCTS COMPANY, INC., Petitioner,
v.
Joseph A. CALIFANO, Jr., Secretary of U. S. Department of
Health, Education and Welfare, Donald Kennedy, Commissioner
of Food and Drugs, Food and Drug Administration and C. D.
Van Houweling, Director, Bureau of Veterinary Medicine, Food
and Drug Administration, Respondents. No. 76-1146. United States Court of Appeals,
District of Columbia Circuit. Argued Jan. 11, 1978.
Decided June 16, 1978.

David Chiras, of the Bar of the Supreme Court of Rhode Island, pro hac vice by special leave of Court with William F. Casler, Sr., St. Petersburg Beach, Fla., Carleton L. Weidemeyer, Clearwater, Fla., William J. Bethune and Mark W. Foster, Washington, D. C., were on the brief, for petitioner.

Also John P. Meade, Washington, D. C., entered an appearance for petitioner.

J. Patrick Glynn, Atty., Dept. of Justice, St. Louis, Mo., with whom Charles R. McConachie, Acting Chief, Consumer Affairs Section, Dept. of Justice, Washington, D. C., was on the brief, for respondents.

Before BAZELON, McGOWAN and MacKINNON, Circuit Judges.

Opinion for the Court filed by Circuit Judge BAZELON.

BAZELON, Circuit Judge:

On February 17, 1976, the Deputy Commissioner of Food and Drugs issued an order

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withdrawing approval of new animal drug application (NADA) 65-381 and denying a request for a hearing. 41 Fed.Reg. 7141 (1976). The drug covered by NADA 65-381 is a fixed combination drug containing in each 14-milliliter dosage unit procaine penicillin G (100,000 units) and neomycin sulfate (25 milligrams). The drug is designed for treatment of acute and chronic mastitis in lactating cows. Masti-Kure Products Company, Inc., producer of the drug, petitions this court to set aside the Deputy Commissioner's order. See 21 U.S.C. § 360b(h).

I. BACKGROUND

A. The Statutory and Regulatory Framework

The Federal Food, Drug, and Cosmetic Act (the Act) prohibits the marketing in interstate commerce of any new animal drug ¹ unless an NADA for the drug has been approved. See 21 U.S.C. §§ 360b(a)(1)(A), 351(a)(5), 331(a). The Act states that the Commissioner of the Food and Drug Administration (FDA) may withdraw approval of an NADA if he finds "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 such 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 . . . ." 21 U.S.C. § 360b(e)(1)(C). The Act defines "substantial evidence" to mean:

evidence consisting of adequate and well-controlled investigations, including field investigation, 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 reasonably 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. § 360b(d)(3).

FDA has promulgated regulations implementing this statutory scheme. See 21 U.S.C. § 371(a); 21 C.F.R. § 5.1(a)(1) (1977). It has required that for a fixed combination new animal drug such as that covered by NADA 65-381, substantial evidence must be provided both that the drug is effective for its intended use and that "(e)ach ingredient designated as active" contributes to the claimed effects. 21 C.F.R. § 514.1(b)(8)(v) (1977). In addition, FDA has by regulation set out standards for "adequate

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and well-controlled investigations" acceptable as substantial evidence of effectiveness. ²

When the Commissioner determines, on the basis of new information before him, that an approved NADA lacks substantial evidence of effectiveness, FDA regulations require him to notify the holder of the NADA in writing and "afford an opportunity for a hearing on a proposal to withdraw approval of such application." 21 C.F.R. § 514.115(b) (1977). Cf. 21 U.S.C. § 360b(e) (1). FDA has developed summary judgment procedures, however, to be used when the holder of an NADA fails to submit substantial evidence of drug effectiveness sufficient on its face to meet regulatory standards. ³ The Supreme Court has in principle approved such procedures, stating that, "(w)e cannot impute to Congress the design of requiring, nor does due process demand, a hearing when it appears conclusively from the applicant's 'pleadings' that the application cannot succeed." Weinberger

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v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 621, 93 S.Ct. 2469, 2479, 37 L.Ed.2d 207 (1973).

B. Proceedings Before FDA

On August 30, 1974, FDA published in the Federal Register a notice proposing to withdraw approval of NADA 65-381. ⁴ 39 Fed.Reg. 31678 (1974). The notice stated there were insufficient data to demonstrate that the ingredients of NADA 65-381 were effective in accordance with the requirements for fixed combination drugs as set forth in 21 C.F.R. § 514.1(b)(8)(v) (1977). ⁵ Masti-Kure thereupon requested a hearing and submitted data purporting to demonstrate the efficacy of the drug covered by NADA 65-381. Joint Appendix (J.A.) at 160. On March 5, 1975, FDA served upon Masti-Kure a proposed order analyzing Masti-Kure's submission and concluding that summary judgment should be instituted since the data submitted failed on its face to meet regulatory standards. J.A. at 684. Masti-Kure was given sixty days "to respond with sufficient data, information, and analyses to demonstrate that there is a genuine and substantial issue of fact which justifies a hearing." Id. Masti-Kure responded on May 9 with a revised evidentiary submission. FDA concluded, however, that the deficiencies in the data were unremedied, and, on February 17, 1976, issued its final order withdrawing approval of NADA 65-381 and denying Masti-Kure's request for a hearing. 41 Fed.Reg. 7141 (1976).

II. THE APPROPRIATENESS OF SUMMARY JUDGMENT

The drug covered by NADA 65-381 is a combination antibiotic containing penicillin and neomycin. It is designed to treat mastitis in lactating cows. Masti-Kure's rationale for combining penicillin and neomycin in a single drug is that bovine mastitis is an infectious disease that results from pathogenic microorganisms, principally Streptococcus agalactiae (strep) and Staphylococcus aureus (staph). Although penicillin is usually effective in eliminating the infection caused by strep, it is sometimes ineffective against staph, which is known to produce an enzyme capable of destroying penicillin. Neomycin, it is postulated, is usually effective against staph, although not against strep. In actual field use, infecting organisms are not identified and the susceptibility patterns not determined before commencing treatment of mastitis. Use of penicillin or neomycin alone, therefore, will produce treatment failures in cows infected with organisms...