Vermont to Sue FDA Over Drug Reimportation

first_imgGovernor & Attorney General to Sue FDA Over Drug ReimportationMontpelier, Vt. — Governor Jim Douglas and Attorney General WilliamSorrell announced August 10 that Vermont will file suit against the Food andDrug Administration (FDA) in U.S. District Court over the issue ofimporting drugs from Canada. Vermont is the first state in the nation tosue the FDA for blocking a responsible reimportation proposal.Vermont had sought a waiver from the FDA authorizing a legal 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 Sorrell agreed the suit was necessary, saying the federalgovernment’s grounds for denying the waiver request are illegitimate.”Vermont presented a legal and responsible plan to import prescriptiondrugs,” Governor Douglas said. “The claims on which they’ve based thisdenial are, in our view, unsubstantiated and we have no choice but topursue any and all legal remedies available. We intend to file suitshortly against the FDA in federal court.””Vermont’s petition was carefully crafted and reasonable,” said Sorrell.”I am amazed that the FDA rejected it, but am looking forward to gettingthis in front of a federal judge.”In response to the FDA’s rejection letter, Administration SecretaryMichael Smith sent a strongly worded reply voicing the administration’sdispleasure at the decision, and informing the FDA that Vermont would befiling a lawsuit.”Your failure to promptly issue regulations to provide for the safeimportation of prescription drugs from Canada, in accordance with section1121 of the Medicare Prescription Drug Improvement and Modernization Actof 2003, has compromised the ability of any state to adequately addressthis important issue,” Smith said in the letter. “We are, therefore,forced to consider development of a reimportation program that conforms toour interpretation of the current laws, independent of your agency.”In addition, Governor Douglas said he would dispatch the Commissioner ofHealth, Dr. Paul Jarris; Commissioner of Human Resources, Cindy LaWare;and his Legal Counsel, Susanne Young, to review New Hampshire’s plan andpursue a multi-state strategy to assist individuals who want to purchasedrugs in Canada.Governor Douglas noted that reimportation is not a long-term solution andsaid he would continue to urge Congress to take immediate action to reformthe American pharmaceutical marketplace.”Congress should act immediately to legalize the reimportation of lowercost drugs from Canada, increase competition among brand namemanufacturers, speed the approval of generic drugs, preserve states’ability to pool their purchases and negotiate deep discounts withmanufacturers, protect state pharmaceutical programs that may be impactedby the new Medicare law, and review recent increases in the cost ofpharmaceuticals,” Douglas said. “The ultimate goal, of course, is to getthe best deal possible for Vermonters on their prescription drugs at localpharmacies here at home.”Attorney General Sorrell serves as the President of the NationalAssociation of Attorneys General. At that association’s recent annualmeeting, Sorrell announced his presidential initiative to study andrecommend actions in response to the high cost of prescription drugs inthe United States. In commenting on today’s developments, Sorrell stated:”This action by the FDA underscores that, unless we take aggressiveactions, we are going to continue to pay the highest prescription drugprices in the industrialized world.”last_img read more