American Cyanamid Co. v. Young
| Decision Date | 27 August 1985 |
| Docket Number | No. 84-1383,84-1383 |
| Citation | 770 F.2d 1213 |
| Parties | AMERICAN CYANAMID COMPANY, Petitioner, v. Frank E. YOUNG, M.D., Commissioner of Food & Drugs, Mark Novitch, M.D., Deputy Commissioner of Food & Drugs, Margaret Heckler, Secretary, Dept. of Health & Human Services and Food and Drug Administration, Respondents. |
| Court | U.S. Court of Appeals — District of Columbia Circuit |
Petition for Review of an Order of the Food and Drug administration.
William R. Pendergast, Washington, D.C., with whom Wayne H. Matelski, Washington, D.C., was on the brief, for petitioner.
Eugene M. Thirolf, Jr., Atty., Dept. of Justice, Washington, D.C., with whom Richard K. Willard, Asst. Atty. Gen., John Fleder, Asst. Director, Office of Consumer Litigation, Dept. of Justice, Thomas Scarlett, Chief Counsel for Enforcement, Office of General Counsel, and Mark A. Heller, Associate Chief Counsel for Enforcement, Food and Drug Administration, Washington, D.C.
Before ROBINSON, Chief Judge, and MIKVA and GINSBURG, Circuit Judges.
Opinion for the Court filed by Circuit Judge GINSBURG.
Nature has well equipped the flea to meet the life-or-death challenge of alighting upon a suitable host; it is estimated that if humans possessed a jumping ability comparable to that of Ctenocephalides canis, 1 a person could leap five city blocks in a single bound. IV ENCYCLOPEDIA BRITANNICA 177 (15th ed. 1974); see also M. ROTHCHILD & T. CLAY, FLEAS, FLUKES AND CUCKOOS 42 (1952). Analogously, Congress in 1968 equipped the Food and Drug Administration (FDA or Administration) with a consolidated statutory framework to meet the challenge of regulating new animal drugs. See Animal Drug Amendments of 1968, Pub.L. No. 90-399, 82 Stat. 343 (codified as 21 U.S.C. Sec. 360b (1982)); S.REP. NO. 1308, 90th Cong., 2d Sess. 1-3 (1968), U.S.Code Cong. & Admin.News 1968, p. 2607. The petitioner in this case, who seeks to market over the counter (OTC) a flea-control product for dogs, asserts that Congress did not equip the FDA as generously as nature did the insectile subject of this proceeding. Specifically, petitioner argues that because the FDA seventeen years ago approved petitioner's product as safe and effective for distribution by veterinarian's prescription, the Administration is powerless to reevaluate the product's safety and effectiveness before allowing the product to be marketed over the counter.
We reject petitioner's argument. As we read the governing statute, the FDA may fully evaluate the safety and effectiveness of a product not only before approving an initial new animal drug application (NADA), but also before approving a supplemental NADA when the proposed change (such as prescription-only to OTC status) has a bearing on the product's safety or effectiveness.
Having found the FDA's investigation within its statutory authority, we further find the agency's conclusion--that petitioner's product has not been proven safe and effective--to be supported by substantial evidence and not otherwise arbitrary or capricious. We therefore affirm the FDA's ruling that petitioner's supplemental NADA seeking OTC status was not up to scratch.
In the mid-1960's, petitioner, American Cyanamid Company (Cyanamid), filed two new drug applications with the FDA, one for the liquid form, and the other for the capsule form of Proban, a drug intended to control fleas on dogs. 2 In a manner reminiscent of the lifecycle of Proban's intended victim, 3 the active ingredient of Proban travels an indirect route from bottle to parasite. The drug is placed in a dog's food; the dog ingests the drug; a flea ingests the dog's body fluids; the flea eventually ingests Proban from the canine blood and, it is hoped, dies.
In 1968, the FDA approved the liquid and capsule forms of Proban as safe and effective for distribution under the order of a licensed veterinarian.
In 1972, Cyanamid filed a supplemental NADA seeking authorization to market liquid Proban over the counter. Working at a pace charitably described as unhurried, 4 the Administration took two years to inform Cyanamid by letter that its application was "incomplete," then two more years to issue a Notice of Opportunity for Hearing, and ultimately, one more year to issue a final order rejecting the supplemental NADA and refusing Cyanamid's request for a hearing. American Cyanamid Co. v. Food and Drug Administration, 606 F.2d 1307, 1309 & n. 4 (D.C.Cir.1979).
Cyanamid petitioned this court to review the Administration's ruling. The appellate panel reversed the agency's order and remanded the case to the FDA, directing that Cyanamid receive the trial-type hearing it had requested. The FDA had invoked its summary disposition mechanism, allowing denial of an application without a hearing if the application presents "no genuine and substantial issue of fact." See 21 C.F.R. Sec. 514.200(c) (1978). This court "recognized a rather broad area" in which the FDA may properly pluck out meritless applications, American Cyanamid, 606 F.2d at 1323; inspecting Cyanamid's papers, however, the court discovered "several material issues of fact and science" entitling the applicant to a hearing. Id.
Cyanamid's victory proved fleeting. In 1980 the Administration published a Notice detailing the factual issues to be considered at Cyanamid's hearing. The list included specific questions concerning the adequacy of Cyanamid's data on the safety and effectiveness of Proban. 45 Fed.Reg. 40236 (1980). A prehearing conference identified six main issues for determination:
I. Has Cyanamid submitted tests by all methods reasonably applicable to show that Proban is safe for OTC use?
II. Do the results of the tests show that the proposed use of Proban is safe?
III. Upon the basis of the information submitted by Cyanamid or other information before the Commissioner, does the Commissioner have sufficient information to determine whether the proposed use of Proban is safe?
IV. Has Cyanamid submitted substantial evidence, consisting of adequate and well-controlled investigations, including field investigations by experts qualified by scientific training and experience to evaluate the effectiveness of Proban, to establish that Proban marketed OTC will have the effect it purports or is represented to have under its prescribed, recommended, or suggested conditions of use?
V. Whether the applicant has shown by appropriate studies, data, surveys or opinion evidence that the proposed labeling for Proban constitutes adequate directions for use?
VI. Are the dangers associated with Proban such that the proposed labeling for Proban does not provide instructions for lay use?
Proposal to Refuse Approval of a Supplemental New Animal Drug Application for Over-the-Counter Sale of Proban Brand of Cythioate Oral Liquid, Initial Decision, No. 76N-0462 (June 16, 1981) [hereinafter Initial Decision] at 3-4. These issues were drawn from the statutory requirements for approval of a NADA. See 21 U.S.C. Sec. 360b(d) (1982).
After receiving the parties' written direct testimony and hearing cross-examination of each participant's witnesses, the administrative law judge (ALJ) issued a decision finding against Cyanamid on each of the above-listed issues, and denying the supplemental application. Initial Decision at 94-95.
Cyanamid appealed the Initial Decision in toto to the Commissioner. Summarizing the result of his examination, the (Acting) Commissioner stated that "although Cyanamid has [doggedly] objected to virtually all aspects of this proceeding, I am unable to conclude that any grounds exist to overturn the ALJ's decision." With some modifications, he affirmed the ALJ's findings and conclusions. Proban Liquid: Denial of Supplemental New Animal Drug Application, No. 33-606 (June 20, 1984) [hereinafter Commissioner's Decision] at 5.
Cyanamid now petitions this court to review and reverse the Commissioner's decision.
Cyanamid dominantly argues that the FDA lacks statutory authority to conduct a full safety and effectiveness review before approving a supplemental NADA. According to petitioner, the Administration must accept without renewed inspection the safety and effectiveness of an animal drug within the bounds of the previously approved NADA, and can investigate only the marginal difference between the original NADA and the supplemental NADA. In this case, therefore, Cyanamid's interpretation would allow the FDA to consider only whether adequate directions for over-the-counter use can be written. Brief for Petitioner at 46-52, 62-71. We reject Cyanamid's position and uphold the FDA's thorough investigation as within its statutory authority.
The issue at hand is not novel in this court. In Rhodia, Inc. v. Food and Drug Administration, 608 F.2d 1376 (D.C.Cir.1979), the FDA rejected Rhodia's supplemental NADA seeking to add an alternative bulk supplier of the active ingredient in Rhodia's product. The FDA rejection of the supplemental NADA rested on new evidence calling into question the safety of the active ingredient.
The court did not reach the issue whether the FDA, as a general matter, had the authority to pursue a full safety and effectiveness review regarding the original NADA when considering a supplemental NADA. Assuming that the FDA had such authority, the appellate panel found the administrative action in Rhodia's case arbitrary and capricious. Id. at 1378-79. In a separate statement, however, Judge Leventhal (also the author of the majority opinion) squarely addressed the question of the Administration's statutory authority. He considered
the FDA construction ... reasonable, and consistent with the language of Sec. 512(e)(1)(E) of the Food, Drug and Cosmetic Act ..., which provides the primary source of FDA authority to approve supplemental NADA's: "The supplemental application shall be treated in the same manner as the original application." 21...
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