Vermont Files Suit Against FDA Over Drug Reimportation

Vermont Files Suit Against FDA Over Drug Reimportation

first_imgVermont Files Suit Against FDA Over Drug ReimportationMontpelier, Vt. – The State of Vermont this afternoon (Thursday Augst 19, 2004) formally filed suitagainst the Food and Drug Administration (FDA) in U.S. District Court inBurlington, Vermont, becoming the first state in the nation to challengethe FDA’s legal arguments for blocking reimportation proposals.”Vermont will not sit back and watch as the cost of health insurance andprescription drugs continues to rise. Nor are we content to simply ignorethe law,” Governor Douglas said. “Real leadership means challenging thoselaws and policies you oppose, and working within our systems to changethem. It is our hope and expectation that Vermont’s leadership will resultin a legal precedent that benefits every Vermonter, and every American.”Governor Douglas acknowledged that the cost of prescription drugs is butone piece of the problem, and reimportation one part of the solution. Ashe has done many times before, Douglas said he would continue to urgeCongress to take immediate action to increase competition amongmanufacturers, speed the approval of generic drugs, preserve states’ability to pool their purchases, protect state pharmaceutical programsthat may be impacted by the new Medicare law, and review recent increasesin the cost of pharmaceuticals.”Reforming the American pharmaceutical marketplace must be our toppriority,” he said. “The ultimate goal is to get the best possible marketprices at our pharmacies here at home.”The complaint argues that the FDA decision was “arbitrary and capricious,and otherwise unreasonable” and in direct violation of the MedicarePrescription Drug, Improvement, and Modernization Act (MMA) of 2003. TheMMA requires the federal government to create rules permittingreimportation of prescription drugs by wholesalers, pharmacists, and statebenefit programs, and to issue guidance describing the circumstances underwhich the FDA will grant waivers allowing reimportation for personaluse-neither of which the FDA has done.According to the complaint, Vermont is seeking a court order that will”require prompt adoption of regulations and waiver guidance andappropriate consideration of Vermont’s proposed program.”Vermont had sought a waiver from the FDA authorizing a pilot drugreimportation plan. The goal of the pilot project was to demonstrate howa plan could be safely implemented, and ultimately serve as a model forother states to implement similar programs.Douglas and Attorney General William Sorrell agreed the suit wasnecessary, saying the federal government’s grounds for denying the waiverrequest are not legitimate.”Vermont presented a legal and responsible plan to import prescriptiondrugs,” Governor Douglas said at the time of the FDA rejection. “Theclaims on which they’ve based (the) denial are, in our view,unsubstantiated and we have no choice but to pursue…all legal remediesavailable.”After the complaint has been filed with the court and served on thefederal government, the federal government has 60 days to respond.A copy of the complaint is available at:http://www.vermont.gov/governor/priorities/priorities.html(link is external)last_img

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