States, Cities Defy U.S. in Importing Drugs

FDA fights attempts to get cheaper Canadian medications

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HealthDay Reporter

TUESDAY, Dec. 23, 2003 (HealthDayNews) -- State and city plans to buy low-cost drugs from Canadian pharmacies are marching steadily forward, even in the face of federal opposition.

After a meeting last Wednesday with U.S. Food and Drug Administration (FDA) officials in Washington, D.C., Boston Mayor Thomas M. Menino vowed to move forward with that city's plans to buy cheaper prescription drugs for city workers and retirees. Canadian prescriptions cost 30 percent to 80 percent less than what U.S. pharmacies charge.

And last week about 12 states, including Illinois, Oklahoma, North Carolina and Ohio met in Atlanta with representatives of Canadian drug companies.

Also last week, these renegade city and state governments found an ally in Sen. Edward M. Kennedy (D-Mass.), who lent public support to the plans.

However, the FDA maintains the plans are illegal and raise serious safety concerns.

Tom McGinnis, director of pharmacy affairs for the FDA, said the agency's attorneys have told city and state officials that "anything would be illegal and at risk of enforcement action from the FDA."

McGinnis added, however, that the FDA does not have "a lot of enforcement resources" and that "we wouldn't do anything until [the plan] was actually in operation."

It will be months before any of those plans are up and running, and each of them will look different.

Boston plans to set up a system to refer 7,000 municipal employees and retirees to a select group of approved Canadian pharmacies.

New Hampshire is planning to set up a similar system, with a Web site that links to Canadian pharmacies that have met certain safety protocols. In addition, the state Department of Corrections will soon start buying prescription drugs from Canada for state inmates. Currently, the state spends $1.9 million on prisoners' drugs every year. Wendell Packard, a spokesman for the governor's office, said he did not know what the savings would be. Finally, New Hampshire also plans to buy mental health drugs from Canada in a plan that should present savings not only for the state but for the federal government as well.

"We would hope that the FDA would see our plan on its merits through its savings and the safety procedures that we are putting into place," Packard said. "We are moving forward with our plan."

Illinois Gov. Rod R. Blagojevich announced Monday that his state would take an aggressive but less defiant route to obtain Canadian drugs. The state submitted a formal request asking Health and Human Services Secretary Tommy Thompson to initiate the first federally approved pilot program for importation.

Blagojevich said in a statement that the new Medicare law allows a pilot program. But Blagojevich, a Democrat, also said he wouldn't forge ahead without the federal government's blessing.

"The State of Illinois would far prefer to work hand in hand with the federal government to safely and legally import prescription drugs from Canada so we can pass on those savings to our seniors, our consumers and the taxpayers," Blagojevich said.

But that blessing doesn't appear to be coming. A senior FDA official branded the Illinois plan as an attention-getting "gimmick," according to a report in Tuesday's Chicago Sun-Times. "Just because some elected officials says that language exists does not make that true, just as having elected officials saying certain kinds of drugs are safe does not make that true," Peter Pitts, the FDA's associate commissioner for external relations, told the paper.

Blagojevich added that he and Minnesota Gov. Tim Pawlenty plan to host a governors' summit in February on the drug importation issue. A study found Illinois, which spends $340 million a year on prescription drugs, could save $90.7 million annually by importing them.

West Virginia, meanwhile, is still researching ways to buy low-cost Canadian drugs for employees, the Medicaid population and the general public, and it hopes to have an outline of a program by mid-January, said Tom Susman, director of the state's public insurance agency.

Unexpected opposition may come from pharmacy concerns up north. "In some cases, we are actually saying no," said David MacKay, executive director of the Canadian International Pharmacy Association (CIPA) in Winnipeg. CIPA represents about 27 mail-order pharmacies, which are responsible for about 75 percent of total cross-border traffic. "We will not enter into formal commercial contracts."

Why wouldn't CIPA be going after this market? Because, MacKay explained, there is an artificial shortage of drugs contrived by a handful of pharmaceutical companies. Given limited supplies, CIPA acts on a "Canada First" basis. "There's no way Canadian supply will be able to subsidize all 50 states in their budget," MacKay said. "They should be focusing their efforts on pharmaceutical companies and reducing prices in the U.S."

CIPA supports the model of states setting up Web sites guiding their citizens to legitimate mail-order pharmacies, but staying out of the actual transaction. This is the model New Hampshire and other entities are considering.

But on the U.S. side of the border, events are taking on a critical mass, including legislation that has been proposed to develop a safe importation program.

More information

For more on buying drugs online, visit the U.S. Food and Drug Administration or the National Association of Boards of Pharmacy.

SOURCES: Wendell Packard, spokesman, New Hampshire Gov. Craig Benson, Concord; Tom Susman, director, West Virginia Public Insurance Agency, Charleston; David MacKay, executive director, Canadian International Pharmacy Association, Winnipeg; Tom McGinnis, Pharm.D., director of pharmacy affairs, U.S. Food and Drug Administration; Rockville, Md.; Dec. 22, 2003, statement, Illinois Gov. Rod R. Blagojevich; Dec. 23, 2003 Chicago Sun-Times

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