Minnesota Believes in Canadian Medicine!

Minnesota plans to launch a website today offering its residents information on how to order prescription drugs from Canada, making it the first state to take concrete action in defiance of the federal government.
The plan represents an escalation of the confrontation over drug costs between the federal government and the more than two dozen states that in one form or another have expressed desires to import cheaper drugs from Canada.
But the movement among states has been largely limited to news conferences, cost studies, and barbs aimed at the Bush administration and the US pharmaceutical industry.
The lack of action shows that months of legal saber rattling and a steady drumbeat of safety warnings by the Food and Drug Administration and the drug industry are having a chilling effect on governors and state legislators.
"In this environment there is a lot of posturing by politicians and finger-pointing, but day after day nothing changes," said Cheryl Rivers, executive director of the National Legislative Association on Prescription Drug Prices in Vermont. "It hasn't been tested legally, and in the environment we're in, there are few governors who would have the moxie to risk the full wrath of the federal government and the drug industry."
Indeed, even the Minnesota plan stops short of what Republican Governor Tim Pawlenty originally outlined last year. The state is not ready to begin a program for state employees to purchase drugs, and it has no fixed date for launch of that initiative.
More typical is what has happened in New Hampshire. Governor Craig Benson, for instance, planned to put up a Canadian prescription drug website for state residents in December. Then he moved the date to mid-January. Most recently, his spokesman said it won't be up until next month.
Wisconsin's governor lived up to his promise to launch a website. But there's a catch. Launched last week, the site has no information about how to order Canadian drugs, just a list of sample prices from anonymous cross-border drug stores.
"I would like to provide you with the names of those websites, but I can't," Wisconsin Governor Jim Doyle wrote on the site. "The Bush administration refuses to permit states to help people save money by purchasing medicine from Canada."
The governors of Iowa and Illinois, meanwhile, who were at the forefront of a rebellion over prescription drugs just a few months ago, are now sounding less defiant. They have applied for permission from Washington to run drug importation programs -- permission that is unlikely to be granted.
Iowa sent FDA Commissioner Mark McClellan and Health and Human Services Secretary Tommy Thompson a proposal to import prescriptions through a network of local Iowa pharmacies. That would ensure that patients are interacting with health professionals who could double check prescriptions for safety, Iowa officials said. Canadian pharmacies participating in the program would be licensed by the Iowa Board of Pharmacy Examiners.
But Iowa Governor Tom Vilsack decided he won't go ahead without FDA approval because it is not worth the risks of violating federal laws, said Roger Munns, spokesman for the Iowa Department of Human Services. "Violating the law was never considered, at least not seriously," he said. "You don't want to do something that's illegal."
Before Minnesota's action today, the only real rebellion over illegal imports has taken place at the local level, where small governments like Springfield, Montgomery, Ala., and, most recently, Westchester County, N.Y., are looking to save a few million dollars a year. In Boston, Mayor Thomas M. Menino is planning to start a limited purchasing program for state employees next summer.
Importation of drugs is illegal, although the FDA has permitted personal importation of 90-day supplies. The agency said it reserves the right to take legal action against public entities such as cities and states that engage in the practice on a broader scale, but thus far it has not followed through on the threat. The agency had no specific comment on Minnesota's planned launch today. Pawlenty met with FDA officials in Washington this month, seeking permission for the launch, but he did not receive it.
"We have told numerous cities and states that the importation of an unapproved drug violates federal law and that any individual or entity that causes the importation of a drug could potentially be liable, both civilly and criminally," said William Hubbard, FDA associate commissioner for policy and planning. "Minnesota has not put its website up yet. We have not seen it, and we do not know how its program will work."
"We would be concerned about any program that would subject citizens of any state to potentially dangerous drugs," he said.
The FDA says importing drugs from Canada could expose consumers to counterfeit or expired drugs. It has conducted two sweeps of mail and shipping facilities in the past six months, identifying hundreds of batches of drugs bound for American consumers that it says were not approved for use in the United States. The Canadian pharmacy industry has said the drugs intercepted by the FDA were approved by HealthCanada and are virtually identical to products available in America.
The Minnesota website will be offering Minnesotans information about prescreened Canadian Internet pharmacies, listing their phone numbers, web addresses, and lists of drugs and prices. It will not contain weblinks to take consumers to the Canadian websites. The state says that is because it wants to make sure consumers see only its preselected list of maintenance drugs and the prices it negotiated in advance.
Looking to ensure safety and address concerns raised by the FDA, Minnesota conducted site inspections of each of the pharmacies with which it has contracted. It also will list only drugs people take regularly -- like those to treat high blood pressure, cholesterol, depression -- and that can withstand the rigors of mail-order shipping. The state is excluding all products that are supposed to be chilled, for instance. It also will not list any prescription narcotics.
Minnesota has crafted an argument that it thinks will stand up in court if the FDA attempts to block its website, said Kevin Goodno, the state's commissioner of human services. The state is not promoting the sale of Canadian drugs for Minnesota residents, Goodno said. Rather, if residents are determined to buy them, the state wants to guide them to Canadian Internet pharmacies that the state has scrutinized for safety.
"If the practice is happening, we have the obligation to step in and provide safety for citizens," Goodno said. "We want to make sure they have a safe environment to do that in. There's information in there about how to be a smart purchaser."

Canada to GUARANTEE imported Medicine

The Canadian government has officially said that it will be responsible for the safety and quality of the large and growing flow of prescription drugs across the border to American consumers, a clarification long sought by U.S. officials.In an official document posted late last week, the Canadian health ministry said all imported drugs must be equally safe and effective whether they are for use by Canadians or for export.The statement, made after many discussions with the U.S. Food and Drug Administration, is an effort to provide better protection to the millions of Americans who now buy their medications from Canada, where price controls often make drugs considerably cheaper.The FDA has voiced concern about the safety and quality of some drugs coming over the border, but said it has limited power to stop Americans from buying them from Canada through the Internet and at pharmacy storefronts. Although the sales have become a big business -- and are growing by some estimates at 50 percent a year -- they are generally illegal under U.S. laws."We appreciate that [Canadian officials] are stepping up to this difficult challenge where we don't have the regulatory authority, and they might," FDA Commissioner Mark McClellan, who worked with Health Canada officials on the new policy statement, said in an interview. "The fact that they are explicitly stating that they are trying to assure safety and effectiveness not only for Canadians, but for the millions of prescriptions sold to Americans through Canada, is a potentially useful step."But one opponent of the cross-border drug sales, Larry Kocot of the National Association of Chain Drug Stores, said the new Canadian position could "lull consumers into thinking that Canadian drugs are as safe as American ones. We believe they're not." For instance, he said, Canada accepts the factory inspections of nations including China and India, while the FDA often sends its own inspectors.The issue of the safety and quality of drugs imported from Canada into the United States has become a contentious one, often pitting consumer groups and their political allies against the U.S. pharmaceutical industry and, to some extent, the FDA.The Pharmaceutical Research and Manufacturers Association (PhRMA) opposes the practice, which cuts drugmakers' profits by allowing Americans to buy the cheaper drugs U.S. drug companies ship to Canada. PhRMA's public argument, however, has primarily been that re-importing drugs from Canada is inherently unsafe and poses a risk to consumers. Its officials have testified that Canadian laws allow drugs from third countries to pass unregulated through Canada, but Daniele Dionne, Health Canada's associate director general, denied that yesterday."As soon as any drug crosses the border into Canada, it has to meet all the regulations of our laws," Dionne said. She described the new posting as a "clarification" rather than a new policy.Congress has twice passed bills that would make it legal to re-import drugs from Canada, but both times the Department of Health and Human Services concluded that the safety and quality of the imported drugs could not be ensured and so the bill did not become law. McClellan said the Canadian statement will help protect consumers, but it does not solve the agency's basic problem with the cross-border traffic."We still can't assure safety and quality because the products go outside of our authority," he said. "The situation remains 'Buyer beware,' and that's not a good way to assure public health."Because the cross-border pharmaceutical sales are often done through online outlets, it has been very difficult to determine how much business is being done. But McClellan said the sales already make up 1 percent to 2 percent of all U.S. drug purchases. Kocot estimated the flow is increasing by 50 percent annually.The FDA has recently begun to crack down on Web sites that advertise cheap drugs from Canada, and has posted its own statement for consumers on how to safely use Internet drug sites. McClellan said the agency's concern has increased as the Web sites have begun to send U.S. consumers more drugs made in nations other than Canada.Canadian law does provide a regulatory exemption for drugs manufactured there for export only, but Dionne said its rules governing manufacturing practices cover these drugs as well, and they are as safe and effective as any others.

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