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| Posted: 2008-07-31 |
| Link to: Federal Outreach Start |
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July 31, 2008 Dear Colleague: Federalism Outreach This communication is part of the Food and Drug Administration's (FDA) outreach to state and local officials, as required by the President's Executive Order 13132, "Federalism." In accordance with the Executive Order, we want to provide you with the opportunity for meaningful input into FDA regulatory policies that have, or may have, substantial direct effects (1) on the states; (2) on the relationship between the national government and the states; or (3) on the distribution of power and responsibilities among the various levels of government. In order to accomplish this, we send state and local officials notices of Federal Register publications that we believe will be of particular interest to them. This notice concerns FDA's proposal and interim final rule to amend certain labeling requirements, including the labeling requirements for certain over-the-counter (OTC) drugs, to include FDA's toll-free number for reporting adverse events, along with a statement that the number is for reporting purposes only, not to obtain medical advice (associated statement) (See 21 CFR § 201.66). FDA's proposal and interim final rule also require pharmacies and authorized dispensers to distribute the toll-free number and associated statement with each prescription for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA). (21 CFR Part 209). The proposed rule was published on April 22, 2004, 69 FR 21778. You will find this proposed rule on the Government Printing Office’s website at: http://edocket.access.gpo.gov/2004/pdf/04-9069.pdf The interim final rule was published on January 3, 2008, to codify the provisions of the proposed rule which, under the Food and Drug Administration Amendments of 2007 (Public Law 110-85), became effective by operation of law on January 1, 2008. You will find the interim final rule on the Government Printing Office's website at: http://edocket.access.gpo.gov/2008/pdf/E7-25426.pdf When published as a final rule, this regulation would require that certain OTC drugs bear FDA's toll-free number for reporting adverse events and associated statement in the "Drug Facts" box, and that pharmacies and authorized dispensers distribute the toll-free number and associated statement with each prescription for which an application is approved under section 505 of the FFDCA. Section 751(a) of the FFDCA provides that ". . . no State or political subdivision of a State may establish or continue in effect any requirement--(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.)." Currently, this provision operates to preempt States from imposing requirements related to the regulation of nonprescription (i.e., OTC) drug products. Even where the express preemption provision is not applicable, implied preemption may arise. As with any Federal requirement, if a State law requirement makes compliance with both Federal law and State law impossible, or would frustrate Federal objectives, the State requirement would be preempted. See Geier v. American Honda Co., 529 U.S. 861 (2000); English v. General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Because of the potential preemption implications of the rule when effective, we are sending you this notice to encourage you to review the proposed rule and the interim final rule and provide us with any comments you may have concerning the impact this rule may have (1) on the states; (2) on the relationship between the national government and the states; or (3) on the distribution of power and responsibilities among the various levels of government. Please send your written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 10-61, Rockville, MD 20852. Please identify your comments with Docket No. 2003N-0342. You may distribute this notice to any office or organization within your state or local government that you believe might be interested. FDA would appreciate your feedback by August 31, 2008. Sincerely,
Richard Barnes |