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States to Help Residents Import Drugs From Canada

By Anna Wilde Mathews, the Wall Street Journal

December 18, 2003

Governors and mayors across the country have come out in favor of buying cheap drugs from Canada , grabbing onto a popular issue. Now, the details of how they plan to implement such programs are beginning to emerge.

How states and cities develop these schemes is important because the efforts carry legal, health and political risks. All of the programs are likely to be closely scrutinized by both sides of the national debate over prescription-drug importation.

The Food and Drug Administration has repeatedly said it is unsafe, and almost never legal, to import prescription drugs because they may not meet
U.S. standards. So states that move ahead could face legal challenges from the federal government - though such challenges could be politically touchy since allowing Americans to import drugs is a popular issue.

The programs also could open up the states and municipalities to private legal action, particularly if any patients involved claim they were harmed by the Canadian imports.

New Hampshire , one of the boldest states, is creating a Web site that will link its residents to Canadian pharmacies from which they can order prescription drugs. The state says it will require that the drugs supplied by such pharmacies come in their original packaging, an effort aimed at curbing counterfeiting. Consumers will need to have prescriptions signed by a licensed New Hampshire doctor, and a licensed Canadian doctor also will have to be involved, says Wendell Packard, a spokesman for Gov. Craig Benson. The new Web site, due to go live next month, will be linked to the Republican governor's own site...

Later, New Hampshire plans to buy drugs from Canada for use by its prisoners, but it will insist that such drugs be made in the U.S. as a safety measure, Mr. Packard says. The state also wants to use mental-health drugs from Canada for Medicaid recipients. Mr. Packard says the state plans to move ahead with such plans even over any federal objections.

Minnesota is also establishing a Web site for Canadian drug purchases and has begun elaborate preparations. The state has asked detailed questions of Canadian pharmacies that hope to sell through the site, including how Canadian physicians would review American prescriptions. It also requested a copy of a pharmacy license and evidence of licenses by the pharmacists and physicians involved.

This week, Minnesota pharmacy inspectors are visiting several of the Canadian companies that said they want to participate. None will be approved without inspections, the state says. "It's more than we would do with a pharmacy in Minnesota ," says Kevin Goodno, the state's commissioner of human services. He says Minnesota planned to move ahead with the Web site even without federal permission.

Officials in West Virginia are exploring plans to import Canadian drugs through local pharmacies rather than by mail order. They want to work with Canadian provincial authorities to verify that Canadian suppliers are legitimate, says Tom Susman, the West Virginia 's acting cabinet secretary for administration. The aim is to allow all state residents to get the Canadian medicines, and integrate the import orders into the systems of pharmacy-benefit managers, the programs through which many workers obtain prescription drugs.
“We'll just use the normal channel, and not try to create a new channel,” says Mr. Susman. West Virginia will ask for federal approval, though it's not yet clear if it would move ahead without it.

Some states, such as Illinois and Vermont , are considering signing up state workers with a Canadian pharmacy-benefit manager that would mail-order their drugs. A spokeswoman for Illinois Gov. Rod Blagojevich says his state plans several safeguards, including inspections of the facilities in the PBM's network and testing of a sample of imported and also domestic mail-order drugs to ensure they aren't counterfeit. The state also would create a new structure that would link employees to pharmacists who would be responsible for tracking their prescriptions, she says. "We're putting in place safeguards that don't exist right now," the spokeswoman says.

Both Vermont and Illinois are seeking federal approval of their programs.Already, Springfield , Mass. , has a limited drug-importation plan that was launched in July. The program raised the co-payments on U.S. drugs for city employees and retirees, while they pay nothing for those from Canada . The small city's initiative so far involves only about 3,000 people ordering Canadian drugs.

A spokesman for the U.S. Department of Health and Human Services says its head, Secretary Tommy Thompson, doesn't have the power to grant waivers to state and city importation programs. The secretary can under some circumstances allow importation if he can certify that the drugs are safe, but Mr. Thompson and previous secretaries haven't found that, the spokesman says. Under the new Medicare bill, the department will study whether there are ways to bring in drugs safely.

In Canada , regulators have made few concrete steps to stem the flood of drugs exports, but some pharmacies are worried they could face shortages. Drug companies are moving to curtail the supply of medicines headed through Canada to the U.S.

The FDA has argued that any drugs that fall outside the closed U.S. distribution system can't be guaranteed safe. State regulators, despite the initiatives of their governors, have often sided with the FDA. Indeed, Paul Boisseau, the executive director of New Hampshire 's board of pharmacy, says his board hasn't worked on the state's importation plan, and without special permission from federal authorities the state's licensed pharmacists probably can't legally distribute imported medicines.

Peter J. Pitts, the FDA's associate commissioner for external relations, says litigation against states or cities is "an option for us if we feel it is appropriate to protect the public health." In November, a federal court ruled that a major operator of Canadian drug storefronts, Rx Depot Inc., must stop helping U.S. consumers get Canadian drugs.

In a letter to California officials in August, the FDA warned that "almost every time a city, county or state program imported a drug from Canada , that program would violate" federal law, and "individuals or programs that cause illegal shipments" are also illegal.

Attorneys say the states could be liable even if they are not themselves importing the drugs. "The federal government can take the position that the state is facilitating an action that is illegal under federal law," says Stuart Pape, a former FDA official who is now an attorney in private practice.

Wednesday, the FDA said it was planning to develop recommendations on how states can save money on U.S. drugs through options such as substitution of generics or comparable medicines, as well as group-purchase plans.  

“We want to facilitate states' ability to provide access to safe and effective medications within the law,” says the agency's Mr. Pitts. The agency says it will work with the Centers for Medicare and Medicaid Services to develop these plans.

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