UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
Petition for Review of an Order of the Food & Drug Administration.
Robinson, Chief Judge, Wald and Ginsburg, Circuit Judges. Opinion for the Court filed by Circuit Judge Ginsburg.
DECISION OF THE COURT DELIVERED BY THE HONORABLE JUDGE GINSBURG
In 1938, Congress armed the Food and Drug Administration with authority to prevent the marketing of hazardous drugs. By the mid-1970's, however, it had become apparent that the legislature's delineation of the FDA's domain was too narrow to enable the agency to protect the public from some of the most dangerous health care products. Mindful of recent misfortunes involving faulty pacemakers and the Dalkon Shield, Congress enacted the Medical Device Amendments of 1976 (Amendments or statute), Pub. L. No. 94-295, 90 Stat. 539 (codified at 21 U.S.C. §§ 360c-360k (1982)), thereby extending the FDA's pre-market surveillance field beyond drugs to medical devices. This case, one of first impression, involves the FDA's administration of the Amendments.
Congress' new prescription for the FDA divided the world of medical devices into three classes, according to the degree of regulation thought necessary to provide reasonable assurance of each device's "safety and effectiveness." Class I encompassed devices whose safety and effectiveness could be reasonably assured by "general controls" set out in various sections of the Food, Drug, and Cosmetic Act, 21 U.S.C. 301-392 (1982). Class II covered devices that posed somewhat greater risks; devices placed in this category would be subject to "performance standards" in addition to the residual general controls. Class III was to obtain devices (1) whose safety and effectiveness could not be reasonably assured by any combination of general controls and performance standards, and (2) whose purported purpose was to aid in supporting or sustaining human life or preventing its impairment, or whose availability presented "a potential unreasonable risk of illness or injury." No device consigned to class III could be sold to the general public until, through a costly and time-consuming process, it had gained the FDA's "premarket approval." See id., § 360c (a) (1).
Congress itself was not positioned to determine the appropriate classification of every medical device then in existence or yet to be invented; nor could it describe the statutory categories with sufficient precision to ensure that each device would simply fall into the proper class of its own accord. The legislators therefore charged the FDA with the task of implementing the Amendments, and thus of essaying judgments appropriate to ensure safe and effective medical devices without stifling innovative technology. See H.R. REP. NO. 853, 94th Cong., 2d Sess. 12-13 (1976) [hereinafter cited as HOUSE REPORT].
Congress drew several initial bright lines, however, that significantly affected the classification process. "Devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution" before the date of the Amendments' enactment were to remain entirely outside the classification scheme until the FDA decided where to place them. See 21 U.S.C. § 360c(c)(3); General Provisions and Classification of 119 Devices, 47 Fed. Reg. 3694, 3694 (1982) [hereinafter cited as Mass Classification Proposal]. Devices introduced after the date of enactment, by contrast, would rank in class III unless shown to belong to a non-class-III family of devices and to be "substantially equivalent" to a particular, already-marketed device within that family. See 21 U.S.C. § 360c(f)(1); 21 C.F.R. § 860.134 (1984). Moreover, under provisions labeled "transitional," class III ranking automatically attached to "any device intended for human use . . . which the in a notice published in the Federal Register before the enactment date has declared to be a new drug." 21 U.S.C. 360j(l)(1). The FDA could later reclassify any device that, for whatever reason, had been "overclassified," but this remedy required a proffer of "new information," id. § 360c(e) -- or, as the FDA formulated the standard, "valid scientific evidence" of safety and effectiveness. 21 C.F.R. §§ 860.7,.123(a)(6).
The instant petition concerns the first attempt ever to reclassify a medical device committed to class III by the Amendments' "transitional provisions." Contact Lens Manufacturers Association challenges the FDA's withdrawal of the agency's own proposal to transfer certain rigid gas permeable contact lenses from class III to class I. 48 Fed. Reg. 56,778 (1983). Claiming that RGP lenses (and hence, RGP lens manufacturers) have suffered disparate treatment in relation to other medical devices (indeed, other contact lenses), CLMA urges that "something has gone very wrong here." Brief of Petitioner at 2. We conclude, however the CLMA's travails are attributable to the intricacies of the legislation Congress ordered, and to the broad administrative discretion Congress conferred upon the FDA. Because our review satisfies us that the FDA has permissibly exercised its considerable discretion in this case, we affirm the agency's action. I.
Contact lenses consisting almost entirely of polymethylmethacrylate -- "hard" lenses -- have been marketed in the United States since the early 1950's. See Regulatory Policy and Proposed Rulemaking for Marketing Contact Lenses, 40 Fed. Reg. 44,844, 44,845 (1975) [hereinafter cited as New Drug Notice]. Because the public's pre-Amendments experience with PMMA lenses was broad and substantially injury-free, see id., these lenses will remain outside the Amendments' classification scheme until the FDA formally decides where to place them. See supra p. 594. That decision has not yet been made; three years ago, however, the FDA proposed to regulate PMMA lenses as class II devices. See Mass Classification Proposal, 47 Fed. Reg. at 3736.
Hydroxyethylmethacrylate lenses -- "soft" lenses -- are a more recent development. The FDA first approved a HEMA lens in 1971. See 47 Fed. Reg. 53,411, 43,415 (1982). In September 1975, citing their relative novelty, the FDA announced that HEMA lenses -- indeed all lenses "other than those consisting [almost wholly] of PMMA" -- had been and would continue to be regarded as "new drugs":
This decision to regulate such contact lenses under the new drug provisions of the Federal Food, Drug, and Cosmetic Act was based on a recognition that new plastic materials that had not been shown to be safe and effective were being introduced for use in the manufacture of contact lenses. The introduction of these new materials led to new lens design and use, new manufacturing methods, and new methods for lens care. The Food and Drug Administration is concerned that the use of these contact lenses may result in serious eye damage if the new material of which they are composed is unsafe for use in the eye, if the user cannot feasibly care for the lenses, or if the highly complex procedures for the manufacture of these lenses are not carefully controlled to assure a product of uniform quality.
New Drug Notice, 40 Fed. Reg. at 44,845. This announcement rendered HEMA lenses class III devices under the Amendments' "transitional provisions." See supra p. 594; cf. infra note 3 (rejection of reclassification proposal).
The product at issue in this case is said to combine attractive features of both lens types described above. "RGP lenses" (like "PMMA lenses" or "HEMA lenses") is a generic term that indicates no single mix of polymers or manufacturing process; but all lenses properly called RGP share certain salient characteristics. The ideal RGP lens permits both the superior visual acuity attainable with a hard lens and the "direct transmission of oxygen to corneal tissue" that the hard lens regrettably prevents. See 47 Fed. Reg. 53,402, 53,406 (1982) [hereinafter cited as Reclassification Proposal]. Nearly a million people in the United States wore RGP lenses in 1982. Id. *fn1 As of 1975, however, RGP lenses, like soft lenses, were comparatively new and untested; since enactment of the Amendments the FDA has regarded RGP lenses as "transitional" class III devices by reason of the same September 1975 Federal Register announcement that resulted in placement of HEMA lenses in the class III category. See supra p. 595; infra p. 598.
Consequently, before a manufacturer can market a particular RGP lens to the public, the manufacturer must demonstrate the safety and effectiveness of that lens convincingly enough to gain the FDA's pre-market approval. "In effect," the manufacturer must obtain "a license to market the device." Brief for Respondent at 5 n.6. (If RGP lenses were class I devices, the manufacturer would be required to make the showing CLMA regards as less burdensome that the lens was "substantially equivalent" to another RGP lens already on the market. See 21 U.S.C. § 360c(f)(1)(1982); supra p. 595. But see infra p. 601.) The expense of obtaining a class III device license -- "estimated at $750,000-$1,000,000 (over and above development costs)," Brief of Petitioner at 11, the bulk of which goes to clinical investigation -- constitutes a significant barrier to entry. Not surprisingly, the first and largest of several manufacturers to surmount the premarket-approval hurdle, Syntex Ophthalmics, commands a dominant share of the market for RGP lenses. CLMA barely disguises its suggestion that Syntex is implicated in the FDA's decision to hold RGP lenses within the class III regime.
That decision did not follow a steady path. In March 1981 CLMA petitioned the FDA to reclassify RGP lenses from class III to class II. Pursuant to 21 U.S.C. § 360c(b) (1982), the FDA referred the petition to an expert advisory committee, the Ophthalmic Section of the Ophthalmic; Ear, Nose, and Throat; and Dental Devices Panel, which recommended the following month that the petition be granted on the condition that CLMA submit additional materials. In November 1981 the FDA announced that although CLMA's upgraded submissions continued to be inadequate, "CLMA's objectives are meritorious," and therefore the FDA intended to adopt the reclassification proposal as the agency's own. See 46 Fed. Reg. 57,648 (1981). The FDA promised to publish a formal proposal in a future issue of the Federal Register ; meanwhile, the agency solicited comment on various economic issues that appeared unrelated to the lenses' safety and effectiveness. See id. at 57,648-49.
In November 1982, a year after the FDA's initial indication of interest, the reclassification proposal emerged. *fn2 "Based on a careful review of new, publicly available, valid scientific evidence," the proposal stated, "FDA has tentatively concluded that . . . certain [RGP lenses] should be reclassified into class I." Reclassification Proposal, 47 Fed. Reg. at 53,404. The proposal was limited to spherical lenses consisting of cellulose acetate butyrate or polyacrylate-silicone. Id. But departing from CLMA's original request for class II designation, the proposal recommended reclassification down to class I. Although the FDA then "believe[d] that sufficient information exist[ed] to establish a [class II performance] standard," the agency also felt that safety and effectiveness could be adequately assured without such a ...