Vt. sues over importing drugs
State challenges US after waiver of ban is denied
Vermont's Republican governor challenged the Bush administration's prescription drug policy in federal court yesterday, marking the first time a state has chosen a legal avenue in the expanding battle over Canadian imports.
Wisconsin, Minnesota, New Hampshire, Illinois, and a handful of cities, including Boston and Springfield, have established import programs for low-cost, overseas drugs in defiance of federal law. In essence, they are daring the federal government to take action. So far, the government has only written warning letters to cities and states.
Vermont Governor Jim Douglas and the state's attorney general, William H. Sorrell, took the fight to the government. A week after the Food and Drug Administration denied Vermont's request for a waiver of the federal ban on drug imports, the state filed a suit in US District Court in Burlington, Vt., against the Department of Health and Human Services and the FDA, accusing the agencies of ignoring congressional instructions to set up a system of waivers.
States commonly sue the federal government over environmental policy, energy, and transportation issues. A lawsuit against the FDA over drug policies is rare, if not unprecedented.
"It is our hope and expectation that Vermont's leadership will result in a legal precedent that benefits every Vermonter, and every American," Douglas said in a press release.
The FDA said it is confident it can fend off the suit, although it said it was pleased that Vermont had chosen to make its case in court instead of operating an illegal importation website such as one Illinois launched this week, which offers links to pharmacies in Canada, the United Kingdom, and Ireland.
"We're confident that our assessment of our authority was well-thought-out when we denied their petition for a waiver," said William Hubbard, the agency's associate commissioner for planning and policy.
Vermont had requested permission to import based on a provision in last year's Medicare prescription benefit law. In response to numerous requests for waivers from cities and states who cited the law, the FDA has said Congress did not give it authority to grant waivers.
The FDA is undertaking a review pursuant to another section of the new Medicare law, studying whether imports from Canada and other countries can be handled safely. The Bush and Clinton administrations have previously said they could not. Now, the FDA and Health and Human Services are awaiting a task force report that will make recommendations on that question.
While the United States will probably try to win the Vermont case on the grounds that federal drug law is its domain, Vermont will be able to argue that states have ample authority over drugs, including pharmacy rules and wholesale licensing, said Donald deKieffer, a Washington lawyer in private practice who specializes in pharmaceutical and trade issues.
Christopher Rowland can be reached at crowland@globe.com.
