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IMPAC Media Coverage |
Prescription Drugs: States in Revolt Look to Canada for Rx Drugs
November, 2003
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here to read file at
AARP's website. |
Older Americans started the trend one by one. But now the issue of buying lower-cost medicines from abroad is
rapidly escalating into a major revolt against high U.S. prescription drug prices, as local and state governments
defiantly challenge the pharmaceutical industry and the Bush administration.
The governors of Illinois, Iowa, Minnesota and Wisconsin are exploring buying drugs from Canada to slash health
costs for state employees and retirees and save taxpayers' money. Republican Gov. Tim Pawlenty of Minnesota is
creating a website to put any Minnesotan in touch with selected Canadian pharmacies that meet state quality
standards.
Out in front of the pack is the mayor of Springfield, Mass., Michael Albano. He's already buying from Canada for
his own family and many of his city's active and retired workers.
"The fact is we're mad as hell, and we can't afford it any more," Albano says, noting that the city's annual
prescription drug costs have more than doubled to $18 million over the past eight years. Buying at Canadian
prices could save up to $9 million a year, he says.
At present Congress is considering legalizing "reimportation"—so called because most drugs sold abroad are made
by American companies.
Current law prohibits anyone, except the drugs' original manufacturers, from importing. But authorities have
turned a blind eye on an estimated 1 to 2 million consumers who do so for personal use, most often by mail order
from Canada.
The Food and Drug Administration (FDA), the White House and the drug industry oppose reimportation, citing safety
concerns and fears that counterfeit drugs could flood the market. But an unlikely coalition of lawmakers in
Congress and the states—Republicans and Democrats—are increasingly rejecting or challenging that argument.
For the governor of Illinois, Rod Blagojevich (D), the safety issue is "the last barricade" put up by the drug
industry "to stop an idea whose time has come," he told the AARP Bulletin.
He likens the reimportation movement to "the kind of revolt that created our country. ... There's a ground-swell
of anger [over U.S. drug prices, the world's highest] that has gone beyond the simmering point."
MAKING COMMON CAUSE
Paradoxically, it is an issue that has united those who would like the U.S. government to regulate drug prices
(as Canada and other Western nations do) and those who believe that free trade and competition are the best way
to lower prices.
That combination makes reimportation "extraordinarily popular," says Robert Blendon of Harvard University's
School of Public Health.
Pointing to opinion polls that show strong public support for the idea, he says its appeal lies in the fact that
"everyone can understand it, people like discounts" and "it doesn't require new federal regulation—it's actually
deregulation."
To many state governors, its appeal also lies in easing crippling costs at a time of huge budget deficits.
Illinois spent $340 million last year on prescription drugs for its 230,000 state employees and retirees. "If we
can go to Canada, our number one trading partner, and get the exact same drug made by the exact same company for
half the cost, why wouldn't we do it?" Blagojevich asks.
In the past few months, he has pursued that possibility with zeal. He formally asked the FDA's permission to
import from Canada (and was refused); enlisted other governors' interest; and sent a state delegation to Canada
on a four-day mission to investigate safety and logistics. He also set up a website where consumers can compare
prices and sign a petition supporting his cause.
"We're not going to do anything without FDA approval," Blagojevich says. But he wants to persuade the agency to
reverse its policy or Congress to alter the law. With other Midwest governors joining in, he adds, "this kind of
effort to bring about change will be very hard to stop."
Meanwhile, the FDA has stepped up law enforcement and warnings on safety. It recently prosecuted the owner of a
chain of American stores that helps consumers get prescriptions filled in Canada for a fee. And, with U.S.
Customs, it conducted a "blitz" on mail order drug shipments arriving from foreign countries, including Canada.
The FDA said that of 1,153 packages examined, "88 percent were violative because they contained unapproved
drugs." FDA chief Mark McClellan added that the blitz "illustrates the real and serious public health risks
created by the importation of unapproved drugs."
But what does "unapproved" actually mean? For example, one intercepted package from Canada contained
Taro-warfarin, a blood thinner made by Taro Pharmaceuticals. The FDA classed it as a drug the agency "has never
approved." True, this entire product, sold in Canada, is not approved for sale in the United States. Yet Taro,
while agreeing with the FDA designation, says the active chemical ingredient is the same in both its American and
Canadian warfarin products. The FDA approved the American version in 1999.
[In its full statement to the AARP Bulletin, the company said: "Taro believes that the FDA's position is correct.
While the active ingredient in Taro's warfarin products sold in Canada and the U.S. is the same, the only way the
FDA can protect the American public is if drugs sold in the U.S. are produced according to specification set by
the FDA and in facilities inspected by the FDA."]
Robert Fraser, director of pharmacy for CanadaDrugs.com, a leading mail order supplier based in Manitoba, makes a
similar point. He says his company received warning notices after a few of its shipments were intercepted in the
blitz, though the chemical composition of these drugs too had received FDA approval. When he pressed officials on
the reason for the action, he says, "their answer was that [the drugs] don't have U.S. labeling. The whole
stoppage was based on that."
Canadian law requires labeling that is different from the American kind—wording in both English and French, for
one thing. But otherwise, Fraser says, the drugs are shipped in the sealed containers made by the U.S.
manufacturers and are exactly the same as those sold in America.
DEFENDING FDA POLICY
William Hubbard, associate commissioner of the FDA, acknowledged to the Bulletin that no chemical tests were
performed on the seized drugs to distinguish counterfeits from the real thing before its report was released to
the media. He also acknowledges that "unapproved" is an umbrella term that can mean anything from counterfeit to
foreign labeling. But, he adds: "We believe that any unapproved drug—no matter what the definition of unapproved
is—is potentially dangerous," because the FDA cannot certify its authenticity or origin.
The FDA has the law on its side in calling unapproved any drugs that carry foreign labels. But the ambiguity of
the term fuels criticisms from lawmakers like Rep. Dan Burton, R-Ind., that the agency is using the safety issue
to "scare consumers" and "protect pharmaceutical companies' profits."
In the interests of safety, some lawmakers and consumer groups are calling for anti-counterfeit seals on
manufacturers' medication containers and for better inspection and accreditation of Internet sites that sell
drugs by mail order.
One new nonprofit group, the Internet and Mailorder Pharmacy Accreditation Commission (IMPAC), has developed a
system to evaluate quality service in American, Canadian and Mexican mail order pharmacies. The commission is
directed by a group of doctors and pharmacists from all three countries.
Jennifer Walkowiak, IMPAC's executive director, says the accreditation process is "highly rigorous" and includes
a two-day inspection of a mail order pharmacy's whole operation, "all the way from how they hire their staff to
how the drug is sent out."
The aim is to offer consumers reassurance by identifying online pharmacies that give excellent service, she says.
Accredited pharmacies must go through the same process every two years.
The first to receive IMPAC accreditation was Fraser's company, CanadaDrugs.com. Others in Canada and the United
States are now being inspected. Some that originally showed interest decided not to apply after seeing the
standards, Walkowiak says, because "they know they can't meet them."
Rep. Gil Gutknecht, R-Minn., applauds IMPAC's efforts, which he calls "way ahead of our own federal agencies that
are sworn to protect the health and safety of the American people."
AARP supports reimporting drugs from Canada for a three-year experimental period, as long as safety concerns are
met. A House bill, passed by a large majority in July, proposes measures to ensure safety, including tamper-proof
container seals and other anti-counterfeit devices. An FDA task force is also currently investigating such
protections. Hubbard estimates it will be "at least three years" before any come into use.
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