Opinion ID: 409641
Heading Depth: 1
Heading Rank: 3

Heading: Denial of Massachusetts' Application for Exemption

Text: 17 The Commonwealth contends further that the agency has failed to demonstrate through reasoned explanation a rational basis under its own standards for denying the Commonwealth's application for exemption, and that the denial is therefore arbitrary and capricious. We review the agency's denial only to determine that it is rationally supported, and if it is we will uphold it even if we would have reached a different result. 18 Under the 'arbitrary and capricious' standard the scope of review is a narrow one. A reviewing court must 'consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.... Although this inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one. The court is not empowered to substitute its judgment for that of the agency.' Citizens to Preserve Overton Park v. Volpe, (401 U.S. 402, 416, 91 S.Ct. 814, 823, 28 L.Ed.2d 136 (1971) ). The agency must articulate a 'rational connection between the facts found and the choice made.' Burlington Truck Lines v. United States, 371 U.S. 156, 168 (83 S.Ct. 239, 245, 9 L.Ed.2d 207) (1962). While we may not supply a reasoned basis for the agency's action that the agency has not itself given, SEC v. Chenery Corp., 332 U.S. 194, 196 (67 S.Ct. 1575, 1577, 91 L.Ed. 1995) (1947), we will uphold a decision of less than ideal clarity if the agency's path may reasonably be discerned. Colorado Interstate Gas Co. v. FPC, 324 U.S. 581, 595 (65 S.Ct. 829, 836, 89 L.Ed. 1206) (1945). Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 285-86 (95 S.Ct. 438, 441-42, 42 L.Ed.2d 447) (1974). 19 Crucial to our review of the rationality of the agency's decision is how we characterize the agency's burden. The Commonwealth argues that because the FDA has not affirmatively found that the Massachusetts statute will increase consumer costs, restrict availability, or unduly burden interstate commerce-factors articulated by the agency as relevant to its best interest of public health standard-it has expressed no rational basis for denying exemption. The agency takes the position, however, that additional regulatory requirements must be affirmatively justified as promoting public health if the regulated devices are otherwise safe and effective. 20 We agree with the agency's statement of the burden. It follows naturally from our affirmation of the agency's statutory grant of discretion and from the structure of § 360k, which preempts all state and local requirements different from or in addition to those imposed by agency rulemaking, but then gives the agency discretion to grant exemptions through separate rulemaking procedures. Furthermore, what is at issue in stating the burden is the agency's interpretation of its own regulation for consideration of applications for exemption. An agency's interpretation of its own regulation is due great deference. See Udall v. Tallman, 380 U.S. 1, 16, 85 S.Ct. 792, 801, 13 L.Ed.2d 616 (1964). It is of controlling weight unless it is plainly erroneous or inconsistent with the regulation. Bowles v. Seminole Rock Co., 325 U.S. 410, 414, 65 S.Ct. 1215, 1217, 89 L.Ed. 1700 (1945). 21 In denying exemption for the Massachusetts requirement of professional audiological testing for hearing aid purchasers, the agency gave this explanation: 22 There is no evidence that only physicians or audiologists are competent to measure hearing loss. Therefore, the agency does not believe that it is appropriate to require a hearing test evaluation by a physician or an audiologist before every sale of a hearing aid. Problems regarding the competency of hearing aid dealers to measure hearing loss will be adequately addressed by strong State and local licensing provisions. 45 Fed.Reg. 67325 (1980). 23 It did, however, grant an exemption for the requirement of such testing as it applies to children under the age of 18. 24 Audiologists are specially qualified to assist in the language development and social and educational growth of a child with a hearing loss. Consequently, mandatory audiological evaluation of a minor will serve an important public health purpose. Id. at 67326. 25 The agency gave a more complete explanation of its reasoning in a concurrent denial of exemption for parallel requirements in other states. 26 After reviewing the conflicting information in the public record regarding the predictive value of audiological testing in determining whether a patient would benefit from a hearing aid, FDA has concluded that audiological evaluation is not necessary to provide reasonable assurance of the safety or effectiveness of hearing aids. There is no evidence that audiological evaluation reduces or eliminates any risk to health presented by a hearing aid. The primary risk to health presented by hearing aids is the possibility that an unnecessary or only partially effective hearing aid will be substituted for necessary medical or surgical treatment, thus depriving the hearing-impaired patient of the benefit of appropriate diagnosis and care and resulting in a detriment to health. Medical evaluation by a licensed physician will ensure that all medically treatable conditions are accurately identified and properly treated before a hearing aid is bought .... (T)he agency concluded that the requirement of mandatory audiological evaluation would increase the cost of obtaining a hearing aid without providing any conclusive assurance that the patient would benefit for amplification. 45 Fed.Reg. 67326, 67329 (1980). 27 The agency reached the conclusion that mandatory audiological testing is undesirable despite conflicting and inconclusive evidence of whether mandatory audiological evaluation would increase the cost of a hearing aid. Id. In relying in part on strong state and local licensing provisions, the agency failed to address the fact that Massachusetts has not chosen to adopt such requirements for hearing aid dealers. 28 The Commonwealth, in effect, prefers to regulate audiological testing by requiring that it be performed by professionals rather than by licensing hearing aid dealers, who also perform such testing. The agency, relying largely on its own findings in choosing not to promulgate regulations requiring professional testing, finds uncontradicted its initial conclusion that such a requirement could increase the cost of obtaining a hearing aid without providing any conclusive assurance that the patient would benefit from amplification. 44 Fed.Reg. 22120 (1979) (proposed rule on Massachusetts' application for exemption). We agree with the district court that (s)uch a finding is sufficient to support denial of an exemption from preemption under 21 C.F.R. 808.25(g)(3) for failure to be in the best interest of the public health. 29 In support of its application for exemption of its more limited provision for waiver of medical evaluation, the Commonwealth argued before the agency that the agency's more liberal waiver provision was being widely abused. Because the Commonwealth failed to document that claim, the agency denied its application for exemption. 30 FDA has not been presented with any convincing evidence that the waiver provision is being widely abused by hearing aid dealers. The agency conducted a survey of State officials to determine whether they were experiencing any problems with compliance with the FDA hearing aid regulation. Of the 39 States that responded to the survey, only Massachusetts stated that it had encountered major problems with regard to compliance. However, Massachusetts did not document its assertion. Therefore, FDA is denying exemption from preemption for the Massachusetts waiver provisions. 45 Fed.Reg. 67325 (1980). 31 The Commonwealth does not argue that there are compelling local conditions that make abuse more of a problem in Massachusetts than elsewhere. 32 The agency's allowance in its own regulations for waiver by an informed adult was based on the conclusion that an unwaivable requirement of medical evaluation would limit the availability of hearing aid devices to those who have personal or religious reasons for objecting to medical evaluation, 6 see 45 Fed.Reg. at 67330, or for those who would have great difficulty in obtaining a medical evaluation due to a lack of a physician in the area, 42 Fed.Reg. 9286, 9292-93 (1977). The Commonwealth does not dispute this premise; indeed, it would allow waiver for those who have religious objections but not for those who have other objections to medical evaluation. The agency's denial of exemption, which preserves waiver for non-religious reasons, is not arbitrary or capricious in the absence of documentation that such waiver has been abused. 33 Because the Massachusetts requirements that were denied exemption were requirements that the FDA had earlier considered and rejected in its own rulemaking, it relied heavily on its initial reasons for rejecting those requirements. The Commonwealth charges that the agency's best interest of public health standard is thus synonymous with what the FDA decides to require on a national level, with virtually no room for deviation. But in the instance of state requirements identical to those that the agency has previously considered and rejected and in the absence of new evidence indicating the desirability of such requirements or their particular efficacy in the state applying for exemption, we cannot say that the agency's reliance on its initial conclusions is inappropriate. Furthermore, the charge that the agency is inflexible or unreasoning in considering applications for exemption is belied by its granting of exemptions for a number of other state hearing aid regulations, see 45 Fed.Reg. 67326, 67331-37 (exemptions granted for various hearing aid purchase regulations in Connecticut, Maine, New Jersey, New Mexico, New York, Ohio and Washington), including Massachusetts' requirement of professional audiological testing in the case of children under the age of 18. The FDA's denial of exemption for those regulations that it found would not serve an important public health purpose is not arbitrary and capricious. 34 Affirmed.