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Vermont to Sue FDA Over Prescription Import Curbs

Ken Rankin
Published Online: Wednesday, September 1, 2004   [ Request Print ]

The increasingly bitter battle over the legality of Canadian prescription drug imports is shifting to the federal courts as officials in Vermont announced plans to launch a legal challenge against the FDA's opposition to Rx importation.

The suit was prompted by the FDA's rejection of Vermont's request for a special waiver authorizing the state to launch a pilot project designed to demonstrate how prescription drugs could be safely imported from Canada where government price controls keep Rx costs lower than in the United States.

"We find it inconceivable that your office would hold steadfast to a position which continues to deny the residents of Vermont an option for other prescription alternatives while Congress works toward a long-term solution to prescription drug prices in the United States," Vermont Secretary of Administration Michael K. Smith told the FDA.

"We believe your stated concerns regarding the safety of selected prescription drugs imported from Canada are unsubstantiated," he added, noting that "we intend to file suit shortly against your agency in federal court."

Vermont Gov Jim Douglas echoed those sentiments, calling his state's proposal for a pilot study "a legal and responsible plan to import prescription drugs," and characterizing the FDA's concerns about Rx import safety as "unsubstantiated."

Officials in Vermont said that their suit against the FDA represents only one in a series of moves designed to lower the cost of prescription drugs for residents of the state.

Douglas announced that Vermont's commissioner of health has been instructed to review Rx importation initiatives in neighboring New Hampshire and "pursue a multi-state strategy to assist individuals who want to purchase drugs in Canada."

Additionally, Vermont will prod Congress to pass new federal legislation immediately "to legalize the reimportation of lower cost drugs from Canada, increase competition among brand name manufacturers, speed the approval of generic drugs, preserve states' ability to pool their purchases and negotiate deep discounts with manufacturers, protect state pharmaceutical programs that may be impacted by the new Medicare law, and review recent increases in the cost of pharmaceuticals," Douglas said. "The ultimate goal, of course, is to get the best deal possible for Vermonters on their prescription drugs at local pharmacies here at home."

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