Opinion ID: 409641
Heading Depth: 1
Heading Rank: 2

Heading: The FDA's Standard for Consideration of Exemption

Text: 6 The Commonwealth argues that 21 C.F.R. 808.25(g)(3) establishing standards for exemption from preemption is inconsistent with Congressional intent. That subpart reads in full: 7 The Commissioner may not grant an application for an exemption from preemption for any requirement with respect to a device if the Commissioner determines that the granting of an exemption would not be in the best interest of public health, taking into account the potential burden on interstate commerce. 8 Among the factors contemplated by the agency in determining whether an exemption will be in the best interest of public health are additional cost to consumer and availability of needed products. 43 Fed.Reg. 18661, 18664 (response to comments on proposed procedures for consideration of applications for exemption). The Commonwealth argues that the FDA has, through 808.25(g)(3), subordinated the standards specifically established by Congress-that the state requirement be more stringent or compell(ed) by local conditions-to its idea of public health, and has thus exceeded its statutory authority. 9 We note first that the Commonwealth made no comment on or objection to 808.25(g)(3) before its final promulgation. We agree with those courts that have held that a party aggrieved by an agency ruling is not estopped from challenging the validity of an agency standard that it has not objected to at the time of its promulgation. See City of Seabrook v. EPA, 659 F.2d 1349, 1360-61 (5th Cir. 1981) (party wishing protection from arbitrary agency action need not become faithful reader of the notices of proposed rulemaking); Dobbs v. Train, 409 F.Supp. 432 (S.D.N.Y.1975) (rule would estop vast majority of potential litigants). We note, however, that unlike the litigants in those cases, the Commonwealth had actual notice of rulemaking. Furthermore, the Commonwealth did not question the validity of 808.25(g)(3) in administrative hearings on its own application for exemption. 10 Simple fairness to those who are engaged in the tasks of administration, and to litigants, requires as a general rule that courts should not topple over administrative decisions unless the administrative body not only has erred but has erred against objection made at the time appropriate under its practice. United States v. Tucker Truck Lines, 344 U.S. 33, 37, 73 S.Ct. 67, 69, 97 L.Ed. 54 (1952). 11 See also Bradley v. Weinberger, 483 F.2d 410, 415-17 (1st Cir. 1973); Getty Oil Co. v. Andrews, 607 F.2d 253, 256 (9th Cir. 1979); Dobbs v. Train, supra, 409 F.Supp. at 435 (courts will not entertain objections to standards not made in agency proceedings). We would hesitate, therefore, to declare 808.25(g)(3) invalid even if it were clearly beyond the agency's statutory authority. 2 12 Because we find that the agency was well within its discretion, however, we need not deal with that tension between procedural and substantive shortcomings. The agency's statutory authority to grant exemption from preemption is plainly discretionary. Upon application of a State ... the Secretary may by regulation promulgated after notice and opportunity for an oral hearing, exempt from (preemption), under such conditions as may be prescribed in such regulation, a requirement of such state. 21 U.S.C. § 360k(b) (emphasis added). In promulgating 808.25(g)(3), the agency did no more than ground that discretion in the overriding purpose of the Amendments, which was to protect the public health by assur(ing) the safety and effectiveness of medical devices, S.Rep.No.94-33, at 51, reprinted in 1976 U.S.Code Cong. & Ad.News 1070, 1103, while accommodating the purpose of the preemption section, which was to prevent an undue burden on interstate commerce through the proliferation of varying state requirements, see id. at 1107; H.R.Rep.No.94-853, 94th Cong., 2d Sess. 45 (1976). 13 The Commonwealth argues that considerations of cost to (the) consumer and availability of needed products, incorporated by the agency into its reviewing process through the best interest of public health standard, are inconsistent with Congress' purpose to emphasize safety and caution in the marketing of medical devices. In the case of those dangerous devices posing significant health hazards that were foremost in legislators' minds, 3 see S.Rep.No.94-33, supra, at 2, erring on the side of restricted availability may indeed be mandated by the Amendments. But in the case of non-dangerous devices such as hearing aids it is eminently reasonable and consistent with overriding public health goals to consider cost and availability when weighing the desirability of additional regulation. 4 14 The Commonwealth would, in effect, read § 360k to require exemption from preemption whenever state regulations are more stringent and do not unduly burden interstate commerce. But that reading cannot be reconciled with the plainly discretionary language of the section. To argue that such discretion is inconsistent with the intent of the Amendments is anomalous given the broad authority that the Amendments give to the FDA to categorize and regulate the wide variety of marketed medical devices. 5 15 (T)he construction of a statute by those charged with its administration is entitled to substantial deference. United States v. Rutherford, 442 U.S. 544, 553, 99 S.Ct. 2470, 2475, 61 L.Ed.2d 68 (1979). We agree with the district court that 21 C.F.R. 808.25(g)(3) is reasonably related to the purpose of the Amendments and therefore uphold its validity. See Mourning v. Family Publications Service, Inc., 411 U.S. 356, 369, 93 S.Ct. 1652, 1660, 36 L.Ed.2d 318 (1973). 16