States challenge FDA in fight over drug reimportation

The struggle between the federal government and the states over prescription drug reimportation has heated up on two fronts but cooled down on another.

Within days of each other, Illinois Gov. Rod R. Blagojevich unveiled a plan to let residents buy prescription drugs from other nations, and Vermont sued the federal government for the right to reimport prescription medications. But at the same time, the federal government announced what it sees as a victory for patient safety. Two companies with stores and Internet sites agreed to stop helping U.S. citizens buy drugs from Canadian pharmacies.

At press time, Food and Drug Administration officials had not yet had time to review the Vermont lawsuit, but they said the state acted within its rights in challenging the federal stance against reimportation.

"We appreciate the fact that [Vermont Gov. Jim Douglas] is working within the legal system unlike other states, like Illinois," said William Hubbard, FDA associate commissioner for policy and planning. The agency will vigorously defend itself in court, he said.

The lawsuit, filed Aug. 19 in U.S. District Court in Burlington, Vt., alleges that the government wrongly denied Vermont's request earlier this year to establish a reimportation program. The FDA rejected the request because it was worried about drug safety. The lawsuit, the first of its kind, comes at a time when states and some physicians are struggling to find ways to help patients safely buy medications priced lower in other nations.

"Vermont will not sit back and watch as the cost of health insurance and prescription drugs continues to rise. Nor are we content to simply ignore the law," Douglas said. "Real leadership means challenging those laws and policies you oppose and working within our systems to change them."

The state claims the FDA violated the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Vermont officials say the law requires the federal government to create rules that allow wholesalers, pharmacists and state benefit programs to import prescription drugs and calls for the government to give guidance on the circumstances under which the FDA would give waivers allowing importation for personal use.

Vermont claims the Bush administration has done neither and is asking the court to require the government to establish rules and guidelines promptly.

Some question lawsuit's odds

Vermont officials hope to guide the way so that their state and others can safely import drugs. Douglas said he sees this as one part of the solution to the nation's prescription drug cost problem.

"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. "The ultimate goal is to get the best possible market prices at our pharmacies here at home

But Joe Cohen, a lawyer specializing in pharmaceutical and legislative issues, said that he doesn't believe Vermont can succeed in court.

"When it comes to the issue of safety, there's a wide discrepancy on the issue," said Cohen, a partner with the Texas office of Beirne, Maynard & Parsons. "If the FDA makes a determination that they don't think something meets the safety and efficacy standard, they have the authority to do that."

Because of the long history of legal precedents establishing the FDA's right to make decisions based on safety, changes in the FDA's reimportation stance would likely require congressional intervention, Cohen said.

Illinois goes forward; Web sites halt

Meanwhile, Blagojevich in Illinois announced that the state will contract with and inspect foreign pharmacies as part of a new online and toll-free drug ordering system.

After trying for a year to convince the FDA, Congress and "anyone and everyone else who will listen," Blagojevich said he could no longer keep asking uninsured citizens to continue to face such difficult financial decisions as paying for their medication or paying for groceries.

"These are real choices people have to make every single day," he said. "And it shouldn't have to be that way. And they shouldn't have to keep waiting for their government to help them. The federal government has failed to act. So it's time that we do."

Illinois estimates that it will save the state's citizens 25% to 50% on prescription drugs by contracting with a pharmacy benefits manager to establish a clearinghouse of state-inspected and approved pharmacies and wholesalers in Canada, Ireland and the United Kingdom. If all Illinois residents used it to buy medications, the program could save consumers an estimated $1.9 billion in the first year.

The program is expected to begin running within a month of its Aug. 17 announcement. It will first target the 500,000 Illinois senior citizens without prescription drug coverage.

Citizens will be connected to a Canadian clearinghouse through the Internet or a toll-free telephone number that will provide information on the price and availability of about 100 of the most common brand-name medications. As a safety measure, the available drugs will be ones that are used for long periods and don't spoil during shipping.

The FDA's Hubbard said the agency will continue to try to explain to Illinois officials the safety and efficacy concerns driving the federal government's opposition to states' drug reimportation efforts.

Illinois joins Minnesota, New Hampshire, North Dakota and Wisconsin in establishing Web sites that connect citizens to Canadian pharmacies the states have approved as safe. At press time, the FDA had not taken actions against those states.

The administration, however, has cracked down on two Internet prescription drug sites that also operated dozens of stores across the country.

FDA officials on Aug. 20 announced that RxDepot and Rx of Canada signed a consent decree in which they agree to permanently stop helping U.S. citizens import drugs from Canadian pharmacies. The firms and two of their corporate officers admitted liability for causing the importation of unapproved new drugs and U.S.-manufactured drugs, according to the FDA. The administration sued the two companies in 2003, and a federal court in Oklahoma issued a preliminary injunction against the businesses in November 2003.