Holland Rantos Co., Inc. v. U.S. Dept. of Health, Ed. and Welfare, HOLLAND-RANTOS

• Decision Date: 17 July 1978
• Docket Number: No. 77-1892,HOLLAND-RANTOS,77-1892
• Citation: 587 F.2d 1173
• Parties: COMPANY, INC., Petitioner, v. UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, Joseph Califano, Secretary of Department of Health, Education and Welfare, Food and Drug Administration and Donald Kennedy, Commissioner of Food and Drug Administration, Respondents.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 1173

587 F.2d 1173

190 U.S.App.D.C. 276

HOLLAND-RANTOS COMPANY, INC., Petitioner, v. UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE Joseph Califano, Secretary of Department of Health Education and Welfare, Food and Drug Administration and Donald Kennedy, Commissioner of Food and Drug Administration, Respondents.

No. 77-1892.

United States Court of Appeals District of Columbia Circuit.

Argued March 30, 1978.

Decided July 17, 1978.

F. Kaid Benfield, Washington, D. C. with whom, Charles H. Barr, Richland, Wash., was on the brief, for petitioner.

Patricia J. Kenney, Atty. for Dept. of Justice, Washington, D. C., with whom John H. Shenefield, Asst. Atty. Gen., Charles R. McConachie, Atty., Dept. of Justice, Washington, D. C., Richard M. Cooper, Chief Counsel, Rockville, Md., Eric M. Blumberg, Associate Chief Counsel for Enforcement for Food and Drug Administration, Washington, D. C.

Before BAZELON, LEVENTHAL and ROBINSON, Circuit Judges.

Opinion PER CURIAM.

PER CURIAM:

Holland-Rantos Co. petitions this court to set aside an order of the Commissioner of the Food and Drug Administration (FDA) denying a hearing and withdrawing approval from the new drug application (NDA) of Nylmerate Jelly. See 42 Fed.Reg. 49521 (1977). Petitioner argues that summary judgment is inappropriate because it has presented evidence of adequate and well-controlled investigations demonstrating the effectiveness of Nylmerate for Haemophilus vaginalis vaginitis. As a second ground for relief, petitioner urges that FDA acted arbitrarily by disregarding, without explanation and without a hearing, the recommendation of the National Academy of Sciences-National Research Council (NAS-NRC) Drug Efficacy Study Group that Nylmerate be considered "effective" for treatment of Haemophilus vaginalis vaginitis. ¹ See Fed. Reg. 15030 (1972). We affirm the Commissioner's order.

It is clear that summary judgment is appropriate if petitioner has not submitted any evidence that on its face meets FDA's regulatory standards for adequate and well-controlled investigations. See 21 U.S.C. § 355(d);21 C.F.R. § 314.111(a)(5)(ii) (1977); Weinberger v. Hynson, Wescott & Dunning, 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973). Holland-Rantos, however, claims to have submitted an investigation by Dr. Herman Gardner that meets FDA's regulatory standards. See Joint Appendix (J.A.) at A-93-A-100. The Gardner study compared Nylmerate's efficacy against that of Sultrin Cream, a drug known to be effective. See 21 C.F.R. § 314.111(a)(5)(ii)(a)(4)(iii) (1977). The observed rate of remission for Sultrin Cream was 56.5%; that for Nylmerate was 27.6%. Nylmerate thus was not shown to be as effective as Sultrin, the active control.

Petitioner nevertheless contends that the Gardner study meets FDA regulatory standards because it is "well-controlled." We decline to interpret FDA's regulations in so self-defeating a fashion. The point of a control is to provide a basis of comparison from which the action of an experimental agent may be measured. When a well-controlled study relates an experimental agent to a control that is known to be effective, it yields meaningful results only if the remission rate associated with the experimental agent is at least as high as that of the control. If the experimental agent yields a remission rate that is less than that of the control, nothing is demonstrated as to the efficacy of the experimental agent, for it cannot be inferred from the study whether that lower remission rate is any higher than what would have been achieved by no treatment or a placebo. If it is to be demonstrated that the experimental agent is more effective than no treatment or a placebo, then the agent must be compared to no treatment or a placebo in an appropriately well-controlled study. Although petitioner argues that the 27.6% Remission rate observed for Nylmerate in the Gardner study proves that Nylmerate is more effective than no treatment, this conclusion has not been established by a well-controlled study. The Gardner study, while well-controlled, compared Nylmerate to Sultrin; and that comparison produced no evidence of Nylmerate's efficacy. ²

We are concerned at FDA's refusal without reasons to accept the NAS-NRC panel's recommendation that Nylmerate be considered "effective" in the treatment of Haemophilus vaginalis vaginitis. FDA's cavalier and unexplained rejection of the opinion of its expert panel strains a "cornerstone requirement" of the administrative process, that of "reasoned decision making." Columbia Broadcasting System, Inc. v. FCC, 147 U.S.App.D.C. 175, 182, 454 F.2d 1018, 1025 (1971). Nevertheless, in the circumstances of this case, we conclude that this behavior does not constitute sufficient grounds to set aside the Commissioner's final order.

In 1962 the Federal Food, Drug, and Cosmetic Act was amended to prohibit the introduction into commerce of any "new drug," See 21 U.S.C. § 321(p), without substantial evidence that the drug was effective for its intended uses. See 21 U.S.C. § 355(d). Since the amended Act required " affirmative agency approval, all NDA's 'effective' prior to 1962 were deemed 'approved' under the new definition, and manufacturers were given two years to develop substantial evidence...