FDA: Legalizing drug imports costly

WASHINGTON – It would cost hundreds of millions of dollars to set up a safe and legal program to import drugs from Canada, the Food and Drug Administration’s head pharmacist said Tuesday.

Tom McGinnis insisted the FDA would never rely on Canada’s assurances that drugs sold in Canada are safe.

McGinnis, the agency’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 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 also spurned proposals from a group of Canadian mail-order pharmacies – which represent the heart of the illegal, multimillion-dollar cross-border drug sales – to allow U.S. regulators to inspect their operations.

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

Despite the FDA’s across-the-board rejections, growing numbers of cities and states are exploring Canadian importation as a way to save money, and Congress is increasing pressure on the agency to find a way to make the process legal and safe.

The FDA position also sets the tone for a new HHS study on the safety of Canadian drug imports, which was required by the new Medicare law as a way to appease lawmakers bent on giving Americans greater access to low-cost medicines.

“Anything can be done with enough resources and the authority to do inspections,” said McGinnis. “But it’s going to be hard to figure out what are the benefits. You’re talking about a lot of resources, and when is cost going to outweigh benefit?”

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. “We also do surveillance and enforcement once the drug is on the market.”

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.

While the agency looks the other way as millions of Americans buy Canadian drugs, FDA officials say cities and states could face legal action if they set up programs to facilitate the sales.

David MacKay, executive director of the CIPA, said the warnings have done little to slow sales. He also 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.

Wisconsin is trying to create a Web site that would allow residents to order from Canadian pharmacies, Gov. Jim Doyle told The Associated Press on Tuesday.

“If we can help individual people buy prescription drugs at a much lower cost, we will really have done something significant,” Doyle said.