30 November 2004

Feds want state's drug importation suit tossed out

MONTPELIER -- The Bush administration on Monday asked a federal judge to throw out Vermont's first-in-the-nation lawsuit seeking to overturn the government's ban on importing prescription drugs from Canada.

In saying the state's arguments "are simply without legal basis," Assistant U.S. Attorney Joseph Perella wrote that Vermont's attempt to force a court to grant permission for drug reimportation is inappropriate.

"The state's claims have no basis in law and should be dismissed," Perella said in a response filed late Monday afternoon in U.S. District Court in Burlington. "The actions the state asserts that the federal defendants must take -- permitting foreign drugs to be freely imported and approving (Vermont's) proposed plan for importing drugs from Canada -- are directly contrary to current law."

Gov. James Douglas and Attorney General William Sorrell filed a complaint in federal court in August, opposing the Food and Drug Administration's denial of a pilot program that would have allowed 20,000 state employees, retirees and their families to buy prescription drugs from Canadian pharmacies.

The governor and attorney general in the lawsuit seek to force the FDA to promulgate regulations allowing for such a program. They also argued that the agency was acting in an arbitrary and capricious manner by denying the state's request.

"Not surprisingly, we strongly disagree with the government's position," said Jason Gibbs, Douglas' chief spokesman. "As the state indicated in its initial filing, the governor believes the FDA's position is arbitrary and unreasonable. It is unfortunate that the federal government feels compelled to drag its feet and waste time."

The government, however, called the state's claims baseless and inaccurate. In its filing Monday, the Bush administration reiterated its position that reimporting prescription drugs is unsafe to American consumers and patients.

The filing also noted that the FDA is in the midst of studying the issue, a course of action required under the Medicare Modernization Act of 2003.

"The federal defendants did not act in an arbitrary and capricious manner by denying the state's petition in light of both the statutory scheme and the federal defendant's ongoing evaluation of issues related to prescription drug importation," Perella wrote. "The federal defendants are following the law as it currently stands."

While Vermont and the federal government trade filings in federal court, several other states have decided to allow their residents to participate in reimportation programs.

In a scheme similar to that implemented this spring in Burlington by Mayor Peter Clavelle, Illinois, Wisconsin and Missouri instituted the I-SaveRx plan that gives residents of those states a way to order prescriptions from Canada, the United Kingdom and Ireland.

But like Clavelle's municipal plan, actual participation in the three-state program has been slow to catch on.

According to press reports from Illinois, only about 1,100 out of a pool of 5 million uninsured people have registered with I-SaveRx. In Burlington, fewer than 100 people had signed on to buy the cheaper drugs.

Nonetheless, say supporters of such reimportation programs, they are a necessary step to take in lowering the cost of prescription drugs.

Rep. Bernard Sanders, I-Vt., has urged Douglas to join his Midwestern colleagues. Sanders, one of the first politicians in the country to address the issue of high-cost prescription drugs, has contended that the Bush administration's failure to allow drug reimportation is tied directly to its support from the pharmaceutical industry.

The industry is adamantly opposed to allowing American consumers to purchase drugs from abroad.

It is a stance the government is still willing to take.

"The federal defendants cannot approve, or promulgate regulations that would permit the importation of prescription drugs from Canada by individual consumers via a state-sponsored importation plan or otherwise merely because the state demands it or because some prescription drugs are allegedly cheaper in Canada," the Bush administration's filing said.

"The federal defendants share the state's concern over the high cost of some prescription drugs," it added. "The state's claims, however, are simply without legal basis."

Vermont has about two weeks to file a response to Monday's filing. Legal experts predicted that a judge was unlikely to rule on the federal government's request before the end of the year.

By DARREN M. ALLEN
Vermont Press Bureau

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