General Medical Co. v. U.S. Food and Drug Admin.

Citation770 F.2d 214
Decision Date16 August 1985
Docket NumberNo. 83-2298,83-2298
PartiesGENERAL MEDICAL COMPANY, Petitioner, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., and Margaret M. Heckler, Secretary Department of Health & Human Services, Respondents.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)

Petition for Review of an Order of the United States Food and Drug Administration.

Herbert L. Fenster, Washington, D.C., with whom Larry R. Pilot, Washington, D.C., was on brief, for petitioner.

Scott T. Kragie, Asst. U.S. Atty., Washington, D.C., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, A. Craig Lawrence and Michael J. Ryan, Asst. U.S. Attys., Washington, D.C., were on brief, for respondents.

Thomas F. Fise, Washington, D.C., was on brief for Counsel for the American Trade Ass'n, amicus curiae, urging reversal.

Before GINSBURG and SCALIA, Circuit Judges, and McGOWAN, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge McGOWAN.

McGOWAN, Senior Circuit Judge:

The pace of proceedings at the Food and Drug Administration (FDA), for whatever reasons, does not rival that of, say, a turn-of-the-century sweatshop in New York City. See McIlwain v. Hayes, 690 F.2d 1041 (D.C.Cir.1982) (affirming FDA's decision, under statute passed in 1960 setting forth 2-and- 1/2-year grace period, to extend deadline for statutory showing until 1984); Corn Products Co. v. FDA, 427 F.2d 511, 513 n. 5 (3d Cir.) (affirming 1968 order, original version of which issued in 1959, that mandated peanut butter should be 90%, not 87%, peanuts by weight), cert. denied, 400 U.S. 957, 91 S.Ct. 354, 27 L.Ed.2d 265 (1970). Almost ten years ago, Congress passed the Medical Device Amendments of 1976 (Amendments), Pub.L. No. 94-295, 90 Stat. 539 (codified at 21 U.S.C. Secs. 360c-360k (1982)). The first cases reviewing the Amendments are now trickling into this court. See Contact Lens Manufacturers Association v. FDA, 766 F.2d 592, 594 (D.C.Cir. July 12, 1985) (CLMA v. FDA ). Here, we review the FDA's order denying the petition of the General Medical Company (General Medical) for reclassification of its "Drionic" antiperspirant device.

This case presents us with some sticky matters of statutory interpretation and some evidence of procedural sloppiness on the part of the FDA. We hold that the FDA has rightly guarded the consumer against the general marketing of a device not yet shown to be both safe and effective, and has adopted an allowable interpretation of the Amendments in so doing. We also hold that, while the FDA was less than punctilious in adhering to some procedures that safeguard manufacturers of medical devices against arbitrary action by the FDA, the FDA's position in this case is strong enough that we see no utility in a remand on procedural grounds. We therefore uphold the FDA's decision to deny General Medical's petition for reclassification of the Drionic device.

I

The general scheme of the Amendments has been ably summarized by Judge Ginsburg in CLMA v. FDA. See CLMA v. FDA, at 592-595. Under the Amendments, the FDA is armed with a different set of regulatory weapons for each class of devices. In general, Class I products may be set upon the stream of commerce subject only to "general controls," such as those necessary to prevent misbranding or adulteration. See 21 U.S.C. Sec. 360c(a)(1)(A) (1982); see also id. Secs. 351, 352, 360, 360f, 360h, 360i, 360j (describing general controls). Class III products, in contrast, must traverse the costly rapids of a "premarket approval." See 21 U.S.C. Sec. 360c(a)(1)(C) (1982); see also CLMA v. FDA, at 596 (noting that premarket approval for rigid gas-permeable contact lenses generally costs $750,000-$1,000,000). Class II products must negotiate the barrier, presumably intermediate in height between general controls and a premarket approval, of a "performance standard." See 21 U.S.C. Sec. 360c(a)(1)(B) (1982).

This litigation concerns only the showing necessary for the FDA to allow reclassification from Class III to Class I. Neither party seems interested at the moment in attempting to reclassify the Drionic device into Class II. In addition, we note that the petitioners do not here directly contest the FDA's initial decision to place the Drionic device in Class III. See generally CLMA v. FDA, at 594, 595 (discussing Act's placement of devices outside scheme of Act or into Class III according to whether they were introduced before or after date when statute becomes effective).

The petitioner has, however, mounted in another lawsuit a challenge of sorts to the FDA's classification of the device in Class III. There, the petitioner has exacted from the FDA the acknowledgment in a settlement agreement that the Drionic device is "substantially equivalent" to a device marketed by the Fischer Company before the effective date of the Act. See Stipulation and Order of Dismissal, General Medical Co. v. FDA, Civ. Action No. 83-3314 (D.D.C. filed Nov. 19, 1984) (reproduced as Exhibit 3 of Petitioner's Post-Argument Brief on the Question of Mootness (D.C.Cir. filed Jan. 7, 1985)). Such an admission would ordinarily be of significant use to a manufacturer of a good introduced on the market after the effective date of the Amendments. See 21 U.S.C. Sec. 360c(f)(1) (1982) (goods introduced after effective date are automatically in Class III unless "substantially equivalent" to goods introduced before effective date).

General Medical is not, however, content with the FDA's admission here. The FDA considers the "substantial equivalence" to be between the Fischer device and "the Drionic device as sold to physicians for prescription," rather than between the Fischer device and "the Drionic device as sold over the counter to the lay person." See Letter from Robert G. Britain, Director, Office of Device Evaluation, Center for Devices and Radiological Health, to Steve R. Trost, Esq. (Sept. 29, 1984) (reproduced as Exhibit 4 of Petitioner's Post-Argument Brief on the Question of Mootness (D.C.Cir. filed Jan. 7, 1985)). General Medical wishes to gain Class I status for the Drionic device for over-the-counter sales. They, we, and the FDA all seem to agree--albeit with varying degrees of discomfort 1--that the FDA's current stance on substantial equivalence makes that status impossible to gain for Drionic devices sold over-the-counter without our ruling here that the FDA must reclassify the device from Class III to Class I regardless of the Drionic device's similarity vel non to other devices. It is to the question of what showing Congress intended to be necessary before such a reclassification could occur that we now turn.

II

The Amendments define a Class III device as

A device which because--

(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that [general] controls ... are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and

(ii) (I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or

(II) presents a potential unreasonable risk of illness or injury,

is to be subject ... to premarket approval to provide reasonable assurance of its safety and effectiveness.

21 U.S.C. Sec. 360c(a)(1)(C) (1982).

General Medical does not seek reclassification of the Drionic device into Class II. Section 360c(a)(1)(C)(i)(II) is therefore not at issue here. The FDA does not claim that the device, which is used to prevent excessive perspiration, is purported to be for use in sustaining human life or for a use of substantial importance in preventing impairment of human health. Section 360c(a)(1)(C)(ii)(I) is therefore not at issue here.

The FDA asserts rather that the Drionic device falls into Class III because insufficient information exists to show that general controls will provide reasonable assurance of the device's effectiveness and because the device presents a potential unreasonable risk of injury. The FDA asserts that in this case it may require General Medical to demonstrate the safety and effectiveness of the Drionic device before it will concede that the device does not present an unreasonable risk of injury.

We uphold as supported by substantial evidence the FDA's findings of fact that General Medical has not shown the Drionic device to be safe and effective, and that the device presents a potential unreasonable risk of injury. See Rhone-Poulenc, Inc. v. FDA, 636 F.2d 750 (D.C.Cir.1980) (upholding as supported by substantial evidence an FDA decision that a new animal drug was not "safe and effective"); Edison Pharmaceutical Co. v. FDA, 600 F.2d 831 (D.C.Cir.1979) (same outcome in case involving drug designed for human use). We uphold as a permissible statutory interpretation the FDA's position that the Amendments allow it to require a showing of safety and effectiveness before conceding that the particular device at issue here does not present a potential unreasonable risk of illness or injury. See Chevron U.S.A., Inc. v. Natural Resources Defense Council, --- U.S. ----, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).

After a brief discussion of the device at issue, we examine the clinical study that is the main battleground between General Medical and the FDA, and the FDA's interpretation of the Amendments allowing it to consider that study insufficiently persuasive evidence for General Medical's contention that the Drionic device should be reclassified into Class I.

A. The FDA's Findings of Fact

The Drionic device is designed as a substitute for chemical antiperspirants, 2 or for the extensive medical treatments sometimes...

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