FDA Argues Drug Imports Too Risky

WASHINGTON – In the international mail facility at New York's John F. Kennedy International Airport, packages of confiscated prescription drugs are stacked floor-to-ceiling.

The thousands of such illegal mail-order drugs (search) stopped at America's entry points, however, are but a small fraction of the multimillion-dollar business that federal regulators are struggling to control.

As millions of Americans turn to Canada for cheaper prescription drugs, the Food and Drug Administration's (search) top pharmacist said Tuesday that it would take hundreds of millions of dollars to set up a legal, safe program to import the medicines.

And despite growing pressure from Congress, he insisted the FDA would never rely on Canada's safety assurances for the drugs shipped out of that country, many of them made in the United States.

Tom McGinnis, FDA's pharmacy affairs director, said the FDA would not piggyback its inspections on the Canadian system because the United States inspects drug manufacturers around the world, while Health Canada (search) often relies on inspections done by the drug maker's host country.

"We want to see everything with our own eyes. We've never accepted inspection results from another country," McGinnis told The Associated Press.

The FDA's stubborn stand on the illegal cross-border drug sales (search) has neither slowed the market nor daunted city and state officials who are eyeing the cheaper drugs as a way to save money.

It also sets the tone for an HHS study on the safety of Canadian drug imports, which was required under the new Medicare (search) law as a way to appease lawmakers bent on giving Americans greater access to low-cost medicines.

"We're asked to do so much with so little," said McGinnis, who was surveying the illegal take at Kennedy Airport last week. "Anything can be done with enough resources and the authority to do inspections. ... (But) you're talking about a lot of resources, and when is cost going to outweigh benefit?"

The FDA also spurned proposals last week from a group of Canadian mail-order pharmacies, which represent the heart of the cross-border drug sales, to allow U.S. regulators to inspect their operations.

Representatives from the Canadian International Pharmacy Association (search) met with Health and Human Services legal counsel William McConagha at FDA headquarters last Thursday as other FDA officials were trying to discourage Boston Mayor Thomas Menino from launching a program for his city to import low-cost drugs from Canada.

Canadian officials defended the safety of their drugs and their inspections.

"We conduct regulatory reviews of drugs to ensure there is sufficient evidence of safety, efficacy and quality before they receive authorization to be sold in Canada," said Health Canada spokesman Emmanuel Chabot.

He said Canada relies on its own inspectors or those from about two dozen countries that meet its requirements for good manufacturing practices.

The FDA has warned repeatedly that Canadian drugs are unsafe because they are not subject to FDA oversight and might be outdated, contaminated, counterfeit or packaged in the wrong dosage.

David MacKay, executive director of the CIPA, said the warnings have done little to slow sales, and he said all the association's pharmacies are highly regulated and licensed.

"The Canadian system is not harming any Canadians," he said. "Why is it that by crossing the border does it suddenly happen that it will harm someone?"

He said customers and the FDA can ensure drug safety by making sure the pharmacies are licensed, have a physical address, require a patient history and doctor's prescription and allow independent or FDA inspection.

McGinnis dismissed the suggestions. "It's just not going to work," he said. "There would have to be mechanisms set up, and we would have to get permission from the Canadian government to inspect."

Two cities - Springfield, Mass., and Montgomery, Ala. - are the only governments buying drugs from Canada so far. But states from New Hampshire to Wisconsin are studying the issue or are ready to start their own programs.