Analysis cites savings in importing prescription drugs from Canada

By Ceci Connolly
The Washington Post

	Rod Blagojevich
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Gov. Rod Blagojevich, a Democrat, hopes the figures will put added pressure on the Bush administration and Congress to loosen regulations that prohibit importing medicine from other countries. He is one of a chorus of state and local leaders who say their budgets are buckling under the weight of soaring pharmaceutical costs.

Although the Food and Drug Administration has never prosecuted individuals who illegally bring lower-cost medications into the United States, the agency finds itself fighting a growing rebellion that has stretched far beyond busloads of senior citizens to powerful local, state and national leaders.

A bipartisan group of senators on Capitol Hill is pushing for enactment of free-standing drug import legislation because they remain doubtful about the prospects for a more comprehensive Medicare prescription-drug bill.

"We're in a situation now where seniors are really desperate to have affordable prescription drugs," said Sen. Olympia Snowe, R-Maine. If Congress does not legalize drug importation, "it is missing an opportunity to allow the American people to have access to lower-cost prescription drugs."

The legislation, which mirrors a House bill approved in July on a 243-186 vote, would allow imports of FDA-approved drugs from FDA-inspected plants in Canada and 25 major industrialized nations.

At a hearing in Boston tomorrow, Minnesota's Republican Gov. Tim Pawlenty will tout his plan for steering thousands of residents to Canadian drug suppliers that receive the state's "stamp of approval." Pawlenty, like Blagojevich and a handful of other governors, is considering waiving drug co-payments for state employees who shop at an authorized Canadian pharmacy.

"If you accept the premise we're at a crisis point and on a trajectory that is unsustainable, somebody has to lead change," Pawlenty said in an interview. "These proposals are not perfect and not the long-term solution, but they do offer the potential for near-term relief and it puts pressure on federal officials to consider change."

By year's end, Pawlenty said he intends to create an Internet site that lists Canadian firms that meet criteria for safety, reliability and credibility.

FDA Commissioner Mark McClellan warned that circumventing the federal regulatory process is a dangerous reaction to understandable frustrations.

"Much as they would like to, state and local governments and private groups cannot provide reliable safety assurances when they purchase drugs from foreign sources," he said in a recent speech. McClellan acknowledged there is little risk in walking into a licensed Canadian pharmacy and filling a prescription. But he said it is risky to shop online from unknown Web sites that purport to be legitimate.

"This is not the time to be opening up new avenues for those willing and able to harm patients for their own gain," he said.

A recent FDA survey identified more than 1,100 drugs illegally shipped into the United States. The violations ranged from improper labels and faulty packaging to counterfeits and one medication that was pulled from U.S. shelves.

With his agency already stretched thin trying to monitor U.S. sales, McClellan said the FDA does not have the resources to undertake new responsibilities overseeing pharmaceutical imports.

"We're against large new gaps in the nation's ability to protect its citizens from potentially unsafe drugs at a time when the threats to the safety of our drug supply are greater than ever," he said.

Proponents of opening foreign drug markets say the FDA is exaggerating safety concerns and has been slow to require anti-counterfeit packaging that could reduce fears about imported medications. The lure for American consumers is costs that can be up to 75 percent less than in the United States because the Canadian and European governments set the prices.

They also point out that many of the most common treatments are made in one of the 900 foreign plants the FDA inspects. Lipitor, a cholesterol-lowering medicine, is made in Ireland. Nexium, the purple indigestion pill, is manufactured in Sweden. Prevacid, an ulcer medication, comes from Japan.

Snowe, who has watched constituents buy medicine in Canada for years, said the FDA has ignored previous congressional votes urging legal importation.

"I just cannot believe the FDA and our government cannot find the means to certify the safety of prescription medications coming across our border," she said. "Where there's a will, there's a way."

Rep. Rahm Emanuel, D-Ill., has accused the Bush administration of siding with the pharmaceutical industry over consumers.

"This issue of safety is a straw man. When the United States government in October 2000 needed a vaccine for anthrax and didn't have it, where did it turn? Canada," he said. "If it's good enough for the U.S. government, why isn't it good enough for the rest of us?"

A report by the Congressional Budget Office concluded that legalizing importation of drugs from Canada and Europe could cut drug spending by $40 billion over the next decade, including $4.5 billion in savings for the federal government.

In Springfield, Mass., where Mayor Michael Albano has become a national figure for his open revolt against the FDA, 1,600 city employees and retirees have received 2,600 prescriptions from Canada since July. That has translated into $400,000 in savings for a community that was forced to lay off police officers and firefighters in its latest budget paring.

The Illinois analysis found that if the state's 230,000 employees and retirees bought routine medications from a Canadian pharmacy, the state would save $56.5 million and consumers would save $34.2 million. Currently, Illinois spends $340 million on prescriptions.

After a meeting with Massachusetts leaders, FDA senior deputy commissioner William Hubbard said the agency has no intention of suing a city or state that helps citizens buy medicine from Canada.

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