Vermont sues FDA over drug re-importation

Vermont is to become the first state to sue the US Food and Drug Administration for its stance over the drug re-importation issue that is dogging the country, after the agency blocked what it termed “a responsible re-importation proposal.” Vermont governor, Jim Douglas, and attorney general, William Sorrell, had wanted the FDA to sanction a system under which members would be able to send their prescriptions to a Canadian firm to be authorised and reviewed before being forwarded to a pharmacy. The latter would then send the product to the patient in Vermont. They had hoped to show that a plan could be safely implemented, and ultimately serve as a model for other states wishing to use similar programmes, but the FDA had different ideas. Without revealing the exact details of the agency’s rejection letter, Governor Douglas said. “The claims on which [the FDA] based [its] denial are, in our view, unsubstantiated and we have no choice but to pursue any and all legal remedies available.” Attorney general Sorrell added: “This decision by the FDA underscores that, unless we take aggressive action, we are going to continue to pay the highest prescription drug prices in the industrialised world.” The FDA has come under criticism from those wishing to legalise the importation of drugs from across the border in Canada and has been condemned for using the issues of patient safety as a smokescreen, with opponents suggesting its real alliance is with the pharmaceutical companies, their profit margins and share prices. The issue continues to remain a sensitive one in the USA, with an army of senators vocal in their support of re-importation and various states looking to legalise their own plans that would make cheaper drugs available. Earlier this year, a bi-partisan group of senators unveiled a draft bill that would sanction the move [[22/04/04b]].