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FDA STATEMENT

FOR IMMEDIATE RELEASE
August 20, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Vermont's Lawsuit on Importing Prescription Drugs from Canada

On August 19, 2004, the State of Vermont and the Vermont Agency of Administration filed suit against Tommy G. Thompson, in his capacity as Secretary of the United States Department of Health and Human Services (HHS), and Lester M. Crawford, in his capacity as Acting Commissioner of the United States Food and Drug Administration (FDA), in the United States District Court for the District of Vermont. The lawsuit seeks declaratory and injunctive relief based on FDA's denial of the State of Vermont's December 4, 2003, citizen petition requesting that the Vermont State Employee Medical Benefit Plan (VSEMBP) be allowed to establish a program for the importation of prescription drugs from Canada.

The lawsuit alleges that FDA's denial of Vermont's citizen petition violates the Administrative Procedure Act. It further alleges that section 1121( l )(1) (codified at 21 U.S.C. § 384( l )(1)) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) violates Article I, Section 1 of the United States Constitution.

HHS and FDA continue to believe that Vermont's proposal to import prescription drugs from Canada would be inconsistent with FDA's statutory responsibility to protect the nation's drug supply and with its Personal Importation Policy. In addition, Vermont's request that FDA promptly issue regulations to facilitate the wholesale importation of prescription medications from Canada under section 1121 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) was properly denied because Secretary Thompson has not yet been able to certify that importation would (1) pose no additional risk to the public health and safety and (2) result in a significant reduction in the cost of drugs to the American consumer. Under Federal law, such certification is required before prescription drugs may be legally imported from Canada.

HHS is working expeditiously on a study on the importation of drugs through an intergovernmental Task Force on Drug Importation. Completion of this required study is critical to making an informed decision as to whether the drug importation program in MMA can be implemented safely.

The United States intends to vigorously defend against the lawsuit.

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