American Cyanamid Co. v. Food and Drug Administration, No. 77-1969

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtBefore TAMM, ROBINSON and MacKINNON; Opinion for the Court filed by SPOTTSWOOD W. ROBINSON, III; SPOTTSWOOD W. ROBINSON, III
Citation606 F.2d 1307,196 U.S.App.D.C. 400
Docket NumberNo. 77-1969
Decision Date23 August 1979
PartiesAMERICAN CYANAMID COMPANY, Petitioner, v. FOOD AND DRUG ADMINISTRATION and Joseph A. Califano, Secretary of Health, Education and Welfare et al., Respondents.

Page 1307

606 F.2d 1307
196 U.S.App.D.C. 400
AMERICAN CYANAMID COMPANY, Petitioner,
v.
FOOD AND DRUG ADMINISTRATION and Joseph A. Califano,
Secretary of Health, Education and Welfare et al.,
Respondents.
No. 77-1969.
United States Court of Appeals,
District of Columbia Circuit.
Argued Dec. 6, 1978.
Decided Aug. 21, 1979.
As Amended Aug. 23, 1979.

William R. Pendergast, Washington, D. C., with whom Wayne H. Matelski, Washington, D. C., was on the brief, for petitioner.

Vicki G. Golden, Atty., Dept. of Justice, Washington, D. C., with whom Charles R. McConachie, Atty., Dept. of Justice, Richard M. Cooper, Chief Counsel, and Edward J. Allera, Associate Chief Counsel, Food and Drug Administration, Washington, D. C., were on the brief, for respondents.

Before TAMM, ROBINSON and MacKINNON, Circuit Judges.

Opinion for the Court filed by SPOTTSWOOD W. ROBINSON, III, Circuit Judge.

SPOTTSWOOD W. ROBINSON, III, Circuit Judge:

On June 3, 1968, the Food and Drug Administration (FDA) approved a new animal drug application (NADA) for Proban, a drug in capsule form manufactured by American Cyanamid Company (Cyanamid) and designed for the control of fleas on dogs. 1 FDA authorized this NADA on a finding that Proban had been shown to be safe and effective for its intended use. 2 FDA attached a qualification to its endorsement of Proban, however, rendering it

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available only on order of a licensed veterinarian. 3

Subsequently, Cyanamid researchers conducted tests that in Cyanamid's view demonstrated that Proban could safely be used without the intervention of a veterinarian. Cyanamid submitted the results of these tests, as well as reports of clinical experience, to FDA and requested a supplemental NADA authorizing over-the-counter (OTC) sale of Proban. After considerable delay, 4 the Director of FDA's Bureau of Veterinary Medicine 5 on November 19, 1976, denied approval of the supplement on the basic ground that Cyanamid had not submitted adequate and well-controlled tests demonstrating that Proban could safely be used by consumers without the direction and oversight of a veterinarian. 6 The Director's decision was published in a document styled "Notice of Opportunity for Hearing" (NOH), and in accordance with the agency's regulations 7 it specified that Cyanamid had 30 days within which to request a hearing and to present additional materials in support of its claim that Proban can be safely marketed OTC. 8

Cyanamid came forward with numerous affidavits of experts disputing the Director's conclusions and buttressing the sought-after change in Proban's status. 9 On September 16, 1977, the Commissioner of FDA issued a final order refusing to approve an NADA for OTC use of Proban and declining to hold a hearing on Cyanamid's request. 10 Cyanamid has petitioned for review of the Commissioner's order and asks us to remand the case to FDA for a trial-type hearing.

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I. THE SUBSTANTIVE LEGAL CONTEXT

The Federal Food, Drug and Cosmetic Act prohibits the introduction into interstate commerce of any new animal drug 11 unless an NADA for the drug has been approved. 12 The substantive criteria governing FDA's decision declining to sanction Proban for OTC use are found in Section 512(d) 13 of the Animal Drug Amendments of 1968, which in pertinent part provides:

If the Secretary finds, after due notice to the applicant in accordance with subsection (c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that

(A) the investigations, reports of which are required to be submitted to the Secretary, pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;

(B) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; . . . (or)

(D) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such condition; . . .

he shall issue an order refusing to approve the application. 14

The Director and the Commissioner both rebuffed Cyanamid's application on the basis of this provision, finding the submitted tests inadequate and ill-designed, and their results inconclusive and in some instances even indicative of the unsafe nature of Proban. 15 The Director and the Commissioner did not indicate reliance on any regulations dealing with these concerns, perhaps because the only ones relevant add little to the statute. 16

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Section 512 deals with applications in general, but the parties are in agreement 17 that it governs here because there are no statutory provisions specifically addressed to supplemental applications 18 or to the showing required to justify marketing a drug OTC. 19 In short, Cyanamid's submission was assayed by the general requirements of Section 512, and was found inadequate to demonstrate the safety of Proban when purchased and administered by dog owners without professional supervision. 20

II. FDA SUMMARY JUDGMENT PROCEDURES

Section 512(c) contemplates that an applicant for clearance to market a new animal drug will normally be afforded an opportunity for an adjudicatory hearing on the application. 21 As with hearing requirements in other areas of the drug laws, 22 however, FDA has decided that efficient administration of its mandate warrants dispensing with a hearing if the applicant's submission obviously fails to meet well-established statutory and regulatory criteria for grant of the requested authority. 23 The

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courts have sustained this course for a simple reason: they "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." 24

There are two broad approaches that FDA has employed to truncate consideration of an application which by statute is otherwise to be ventilated in a trial-type hearing. 25 Under one approach, FDA has exercised its rulemaking authority to refine the statutory standards. 26 Then, "where it is apparent at the threshold that the applicant has not tendered Any evidence which On its face meets the statutory standards as particularized by the regulations," 27 FDA may justifiably reject the application without conducting a hearing that could be no more than a hollow ritual. The Supreme Court's decision in Weinberger v. Hynson, Westcott & Dunning, 28 upheld this summary judgment procedure, cautioning, however, that where the regulations are so imprecise that it is not possible to say confidently from the face of the submission that the standards have not been met, denial of a hearing is improper. 29

We have declined to undertake categorical classification of regulations as "precise" or "imprecise", however, and have suggested that "the precision of a regulation will vary with the context in which it is invoked." 30 But when a statute or regulation utilizes but does not particularize broad judgmental concepts, and requires "adequate and well-controlled investigations" 31 or "adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions" proposed, 32 it is difficult to demonstrate that a submission is conclusively deficient. A study should not, and according to FDA will not, be deemed conclusively inadequate unless it totally fails "even to attempt to

Page 1313

comply" 33 with standards whose application call for subjective and discretionary judgments.

Hynson 34 and our own decisions 35 have indicated that when FDA's objection to a submission has no foundation in any specific regulation, it "cannot trigger a summary disposition," 36 but these statements must be taken in context. When FDA denies or withdraws approval of a drug, it often provides only summary notice of its proposed denial or withdrawal to the affected manufacturer, who is afforded a short period of time within which to respond. 37 FDA then issues a final denial or on occasion may grant a hearing. Particularized regulations are necessary to provide the drug manufacturer with notice as to just what its submission must contain to warrant initial or continued authorization to market a drug. 38

Most of FDA's summary action has concerned drug efficacy, not drug safety. 39 Indeed, the impetus to FDA's formulation of summary judgment procedures was the 1962 Drug Amendments to the Federal Food, Drug and Cosmetic Act, 40 which, by defining "new drug" to mean any drug not generally recognized as effective as well as safe, for its intended use, 41 imposed for the first time FDA pre-marketing review of the effectiveness of drugs. The Amendments provided that a drug would not be approved unless the application presented "substantial evidence" 42 based on "adequate and well-controlled investigations" 43 of the drug's efficacy. In order to carry out this directive efficiently, FDA fashioned regulations that refined and particularized what would reasonably be deemed "adequate and well-controlled investigations." 44

The Federal Food, Drug and Cosmetic Act contains no strictly comparable provision delineating the nature of the evidentiary showing required to prove the safety of a new drug. 45 Perhaps for this reason, or because there is less ground for generalizing as to the types of tests and results necessary to demonstrate a drug's safety, or because it faces a more manageable workload in this area, FDA has not seen fit to promulgate detailed regulations defining the kinds of safety tests it would consider adequate or the sort of margin of safety that it would deem sufficient.

Nevertheless, FDA...

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