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Vermont sues FDA for denial of drug import proposal

Physician Practice Advisor, September 3, 2004

Vermont has filed suit against the federal Food and Drug Administration (FDA) seeking declaratory and injunctive relief based on FDA's denial of the state's 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.

The Department of Health and Human Services (HHS) is working on a study on the importation of drugs through an intergovernmental task force on drug importation. According to HHS and the FDA, 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.

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