Cite as: 531 U. S. 341 (2001)
Opinion of the Court
expressly disclaims any intent to directly regulate the practice of medicine, see 21 U. S. C. § 396 (1994 ed., Supp. V), and even though off-label use is generally accepted.5
Conversely, fraud-on-the-FDA claims would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court. Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA's evaluation of an application. As a result, the comparatively speedy § 510(k) process could encounter delays, which would, in turn, impede competition among predicate devices and delay health care professionals' ability to prescribe appropriate off-label uses.6
Respondent relies heavily on Silkwood v. Kerr-McGee Corp., 464 U. S. 238 (1984), which it reads to "creat[e] a virtually irrefutable presumption against implied preemption of private damage remedies predicated on an alleged conflict with a federal remedial scheme." Brief for Respondent 34.
5 See Green & Schultz, Tort Law Deference to FDA Regulation of Medical Devices, 88 Geo. L. J. 2119, 2133 (2000) ("Physicians may prescribe drugs and devices for off-label uses"); Smith, Physician Modification of Legally Marketed Medical Devices: Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act, 55 Food & Drug L. J. 245, 251-252 (2000) (discussing off-label use in terms of the "practice of medicine doctrine[, which] stands firmly for the proposition that regulatory efforts are directed primarily at device marketing by manufacturers, not device use by physicians"); Beck & Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L. J. 71, 72 (1998) ("Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethics, FDA, and most courts recognize").
6 In light of the likely impact that the fraud-on-the-FDA claims would have on the administration of the Administration's duties, we must reject respondent's contention that these claims "will . . . affect only the litigants and will not have the kind of direct impact on the United States, which preemption is designed to protect from undue incursion." Brief for Respondent 30 (citing Miree v. DeKalb County, 433 U. S. 25 (1977)).
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