Government

Drive to reimport drugs outpacing U.S. effort to study safety

Congress is pushing forward with legislation, while states continue to give citizens information on how to buy medication from Canada.

By Joel B. Finkelstein — Posted May 10, 2004

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Washington -- A federal task force is working to assess the safety and practicality of allowing individuals to import prescription drugs, but the public, state governments and Congress aren't waiting for recommendations.

Even as the task force, mandated by last year's Medicare reform bill, met for its fourth of six "listening sessions," more states and localities announced plans to implement reimportation proposals, yet another congressional reimportation measure was introduced and a coalition of seniors groups began lobbying drug companies to stop embargoing Canadian Internet pharmacies that export to the United States.

Rhode Island is only the most recent state to introduce a Web site offering residents information on ordering prescription drugs from Canadian Internet pharmacies. The state decided to link to the Web site created by Wisconsin for information on actual pharmacies. Minnesota and New Hampshire also have made similar information available to residents.

"Whether we like it or not, people are going to Canada," Wisconsin Gov. Jim Doyle told the task force. "They are going in bigger and bigger numbers because the simple dollars demand it, and it is the only option that many of them have."

Last month, two new Senate reimportation bills were introduced, and another one reportedly is on the way. The measures' proponents question the fairness of Americans having to pay more than Canadian or British patients when drugs from those and other countries are readily available.

"One-quarter of the drugs that Americans use today are already legally imported into the United States," said Edward Kennedy (D, Mass.), a co-sponsor of a new bipartisan bill. "The catch is that the law allows that drugs be legally imported by the drug companies themselves, who then sell them at the high U.S. price."

Prescription drugs should be available at the lowest price possible, but patient safety should remain the first priority, said AMA President Donald J. Palmisano, MD. "Any new drug reimportation law or regulation must assure that these reimported drugs are approved by the FDA for sale to America's patients," he said.

Beliefs about the price disparities between the United States and other countries might be somewhat distorted, experts noted. Drug prices in Canada and other developed countries, while cheaper in absolute terms, correspond closely with the lower incomes in those countries.

"It's a myth that Canadian patients have access to drugs because they are lower priced," Durhane Wong-Reiger, PhD, chair of the Consumer Advocare Network, a Canadian coalition of health care consumer organizations and individuals, testified at a recent task force session. "I think that most Canadians would be astonished to hear that drugs are cheap. We're told over and over again, we can't have access because the drugs are expensive," she said.

Lack of access

The real problem in the United States isn't the cost of drugs, but the lack of access to the discounted prices negotiated by health plans, pharmaceutical company officials said.

But there is a difference between Americans' and Canadians' actual access to pharmaceuticals, they said. Canadians don't have access to all the new drugs sold in the U.S. market.

The United States "is a wealthy country, and we demand innovation," said Robert A. Freeman, PhD, executive director of public policy for AstraZeneca Pharmaceuticals. It makes sense that Americans foot the bill for research and development.

That argument has gotten lost in technical explanations from the drugmakers, which are now on the losing side of public perception, experts said.

The public sees it as a grandmother who can't afford her heart medicine versus the pharmaceutical industry that wants to fatten profit margins, said Nancy Mattison, PhD, president of the Mattison Group, a consulting firm based in Princeton, N.J. "It's a lot easier to pay attention to the side of the issue that you can put a face on," she said. (See correction.)

Supply and demand

Public pressure appears to be overcoming both safety concerns and strong opposition from the Bush administration and driving bipartisan agreement in Congress to act on the issue. But the next obstacle could prove more intractable: the politics of supply and demand.

Economists point out that in terms of population, Canada is just a fraction of the size of the United States, so that even a small portion of U.S. patients ordering medication from across the border could overwhelm current distribution systems.

There already have been anecdotal reports that U.S. exports are bleeding off prescription drug supplies that Canadians need. Jirina Vlk, a spokeswoman for HealthCanada, said the agency had not seen proof that U.S. demand is affecting drug availability for Canadian citizens, but it is monitoring the situation very closely.

Canadian laws do not allow the government to restrict exportation of prescription drugs, but several large drugmakers have stepped in to stop the practice.

Pfizer Pharmaceuticals cut off three Canadian Internet pharmacies that were sending drugs to Americans. The company always had an agreement with distributors that bars exportation, but this is the first time that Pfizer has had to enforce it, said spokesman Jack Cox.

The action has spurred a boycott of the company's over-the-counter products by the Minnesota Senior Federation, which hopes to discourage other firms from following Pfizer's lead.

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ADDITIONAL INFORMATION

Reimportation legislation

The most recently introduced bill, which has bipartisan support from several Senate leaders, would:

  • Establish safety procedures to ensure that drugs imported legally are authentic and have been approved by the Food and Drug Administration and manufactured in FDA-supervised plants.
  • Give the FDA new authority and resources to help prevent counterfeiting or adulteration of drugs shipped into the United States.
  • Impose rules on pharmaceutical companies to keep them from evading the law through supply restrictions that would constitute unfair trade practices.

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External links

Thomas, the federal legislative information service, for bill summary, status and full text of the Pharmaceutical Market Access and Drug Safety Act of 2004 (S 2328) (link)

Dept. of Health and Human Services Task Force on Drug Importation (link)

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