BETHESDA, Md. - Like it or not, Americans in the northern sections of the country are crossing the Canadian border to purchase cheap prescription drugs, Wisconsin Gov. Jim Doyle said.
Doyle, a Democrat, was among the 30 or so speakers who addressed the federal task force on drug importation (used interchangeably with "reimportation") established as part of a congressional mandate to study whether bringing FDA-approved drugs from other countries can be done in a cost-effective, safe manner.
The governor told task force members that drug importation would "create competition" within the U.S. However, Bruce Kuhlik, an attorney with the Washington-based Pharmaceutical Research and Manufacturers of America, told the panel that importation would "import price controls."
While those views are a matter of debate, Lothar Dueck, a pharmacist in Winnipeg, Manitoba, and co-founder of the Coalition for Manitoba Pharmacies, testified that Americans bent on buying drugs from Canada are creating drug shortages and higher prices for their northern neighbors.
"Health care professionals in Canada are astonished that any American politician would tell Americans to ignore their laws and buy drugs in Canada," Dueck said. "Politicians who tell Americans to buy drugs in Canada should be ashamed of themselves."
Indeed, while it is currently illegal to import drugs from other countries, the FDA traditionally has looked the other way. However, as part of the new Medicare law signed by President Bush in December, U.S. residents will win the right to purchase drugs from Canada if Health and Human Services secretary Tommy Thompson certifies that it is safe. (See BioWorld Today, Dec. 1, 2003.)
The 13-member task force assisting Thompson in reaching a decision is chaired by U.S. Surgeon General Richard Carmona and includes FDA commissioner Mark McClellan, who was recently confirmed by the Senate to serve as administrator of the Centers for Medicare and Medicaid Services.
The importation proposal does not include biologics. Nevertheless, Sharon Cohen, vice president of government relations at the Washington-based Biotechnology Industry Organization, told the panel that BIO opposes the practice.
Meanwhile, as stated by Doyle, it is well known that senior citizens and young, poor families with children who need to save money end up looking toward Canada for less expensive prescription drugs.
To make the task a little easier for his own constituents, Doyle's administration created a website (www.drugsavings.wi.gov) "to provide people with alternatives to buying drugs," Doyle said. The website lists three Canadian pharmacies, each of which has been visited by representatives from Wisconsin and confirmed legitimate, said Doyle, who believes pharmaceutical companies oppose importation because it will cut into their profits.
Doyle said the website received 87,000 hits in the past six weeks.
"Reimportation holds the promise," he said. "It's time for the government to stand with us against the drug companies to make drugs more affordable and accessible."
Doyle and other speakers said tight government regulations would make importation safe.
Regulations likely would be necessary to control importation because the Canadian government does not regulate prescription drugs shipped into the U.S. And if Dueck had his way, that would be enough incentive to force the U.S government and drug companies to solve their own problems.
"We are paying the highest prices we have paid in a decade because of reimportation," said Dueck. "The prices are as high as the price controls will allow."
Furthermore, companies like New York-based Pfizer Inc. and others have taken matters into their own hands, warning Canadian pharmacies that their shipments will be lighter if they keep selling into the U.S., Dueck said.
America's tug-of-war also is creating a shortage of Canadian pharmacists who work in stores, said Dueck. "They can make more money working for Internet pharmacies, so now we have a shortage of pharmacists," he said.
Indeed, the Internet presents a slew of problems.
While Doyle and Peter Neupert, chairman of the board of Bellevue, Wash.-based drugstore.com, advocate drug purchases through their own Internet sites, Neupert, at least, said the practice of buying via the Internet can be risky.
Neupert testified that the Internet has empowered consumers, but also it has created an avenue for unscrupulous characters looking to make a buck in the prescription drug business.
The major risk, Neupert said, is that consumers often have no idea who they are dealing with over the Internet. To provide some guarantee the safety of Internet pharmacy sites, Neupert recommended that the FDA implement a certification process.
Already 2 million Americans have logged on to the Internet to purchase drugs. "I think it is a mistake to allow consumers to try to figure out importation [via the Internet] on their own," Neupert said. "Commercial importation would be better."
He said if 2 million Americans tell 10 friends that they are saving $100 a month by purchasing off the Internet, "then pretty soon it is going to be 4 million Americans - and it will go up from there."
While many Internet purchases are lifestyle drugs like Viagra and Lipitor, a growing number are controlled substances such as the painkiller OxyContin.
That begs the question: Who is responsible if adverse events crop up or if a product turns out to be counterfeit?
When asked that question by Amit Sachdev, a panel member and acting FDA deputy commissioner for policy, Doyle said the state of Wisconsin doesn't assume any liability under such circumstances, just like it wouldn't take responsibility if events surfaced due to a drug sold in a pharmacy. However, he said if such a problem were to occur with one of the three pharmacies listed on the Wisconsin website, "we would take the pharmacy off the list."
The next meeting of the task force is scheduled for April 28. Health care professionals will be asked to speak on the issue. For more information, check the HHS website at www.hhs.gov.