21 October 2004

Canadian Drugs, Banned by FDA, Are Safe as Those Sold in U.S.

Oct. 21 (Bloomberg) -- Prescription medicines from Canada, banned from the U.S., are at least as safe as those sold by American drugstores, according to a Harvard University professor, state regulators and Canadian authorities.

Inspections and anti-counterfeiting measures in Canada and other industrialized countries are just as effective as U.S. systems, said Jerry Avorn, a Harvard Medical School drug safety specialist. Carmen Catizone, president of the National Association of Boards of Pharmacy, a state regulators' group, rates U.S. and Canadian drugs as equally safe.

``The FDA already does have in place a mechanism for certifying products made overseas and could use this same approach,'' Avorn said in an interview Oct. 19. With additional staff and funding, the agency would be able to inspect pharmacies and wholesalers abroad, he said.

Drug importation is an issue in the U.S. presidential campaign. Democratic nominee John Kerry, a four-term Massachusetts senator, supports lifting the U.S. ban in favor of a system with provisions such as drug tracking and registration of exporters, campaign policy chief Sarah Bianchi said in August. President George W. Bush said Oct. 8 that he would back legalized imports once safety can be assured.

``The issue here is by no means criticizing the Canadian drug supply,'' said Megan Hauck, deputy policy director of the Bush campaign, in a telephone interview Oct. 19. ``The question is: How do you control the borders when you open up reimportation? There is no way to certify'' that the drugs are safe, she said.

$1 Billion in Sales

Americans bought more than $1 billion in medicines last year from Canada, where government regulations hold prices as much as 70 percent lower than in the U.S. Drugs sold in Canada come from many of the same factories that supply the U.S. The U.S. Food and Drug Administration hasn't enforced the ban on imported drugs for individuals filling their own prescriptions.

``They're the very same pills coming down the chute into identical bottles,'' said Gary Passmore, staff director of the Congress of California Seniors advocacy group, in a September interview. Passmore was part of a state delegation that toured four Canadian pharmacies in July.

The FDA already inspects plants in Ireland, Puerto Rico and elsewhere that produce and package prescription drugs legally sold in the U.S. and could extend the same system to foreign pharmacies, Avorn said. New York-based Pfizer Inc.'s Lipitor heart pills and Natick, Massachusetts-based Boston Scientific Corp.'s Taxus heart stent are made in Ireland with FDA oversight.

`Smart Investment'

Funding and staffing to extend the system to pharmacies ``would be a very smart investment considering the hundreds of millions it would save American consumers,'' he said. Avorn wrote the 2004 book, ``Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.''

The association of state pharmacy boards, based in Park Ridge, Illinois, supports a system of inspections and paper ``pedigrees'' tracing a drug's path from factory to pharmacy, group president Catizone said in an interview last week.

``If we make sure that pharmacies and wholesalers are only buying from approved sites, then we could have a safe importation system,'' Catizone said.

The U.S. is investigating 22 cases of drug counterfeiting, according to the FDA. Canadian officials have reported one case, the Royal Canadian Mounted Police said, and none are under investigation by Health Canada, said Jirina Vlk, a spokeswoman.

No Problem in Canada

``We really don't have a problem in Canada'' with counterfeit drugs, Vlk said in a telephone interview Oct. 19. Health Canada would normally alert law enforcement officials when drug counterfeiting is detected, she said. The U.S. and Canada already have discussions and cooperation on drug approval and safety, she said.

The safety debate is separate from the issue of whether Canada's drug-distribution system could actually handle legalized imports. David Mackay, executive director of the Canadian International Pharmacy Association in Winnipeg, Manitoba, said demand might surge to $50 billion a year -- more than three times the size of the country's $15.9 billion drug market.

``That's why this is so incredible and impracticable and impossible,'' Mackay said Oct. 19. ``That's why this is never going to happen.''

Prescription drug sales in the U.S. were $216.4 billion in 2003, according to Caroline Lappetito of IMS Health Inc., a seller of drug market data based in Fairfield, Connecticut.

Limits on Shipments

Pfizer, London-based AstraZeneca Plc, Indianapolis-based Eli Lilly & Co., Brentford, U.K.-based GlaxoSmithKline Plc and other drugmakers limit the amount of medications they send to Canada to reduce sales back to the U.S. Manufacturers would generate 40 percent less revenue on medicines imported from Canada than those bought in the U.S., according to Alan Sager, 57, an economist at Boston University.

European regulations require drugs to be sold in tamper- proof ``unit-of-use'' packaging that ensures no hands touch a drug after it leaves the factory. U.S. distributors and pharmacies receive bulk shipments of pills that druggists then break down into individual packages.

Wholesalers in Europe have used international trade in prescription drugs to save consumers money for more than 20 years without the counterfeiting or safety issues Bush has raised, said Peter Rost, a Pfizer marketing vice president.

``I don't think he has a full understanding of how it works,'' Rost said in a telephone interview last week. ``You don't have consumers buying drugs from Third World countries.''

`Multiple Opportunities'

``There are multiple opportunities for medications to be tampered with or counterfeits to be introduced'' in the U.S., said Dana Noble, executive officer of the Internet and Mailorder Pharmacy Commission, an international pharmacy inspector in Bennington, Vermont.

U.S. procedures ``give you an uneasy feeling compared to what you goes on in Canada,'' said Noble, who has inspected mail order pharmacies in Manitoba and British Columbia.

``The U.S. system is probably the safest system in the world,'' said Tom McGinnis, the FDA's deputy director for pharmacy affairs, in a telephone interview last month. ``All countries have the same problems the U.S. does,'' with counterfeiting and drug diversion, he said.

Senate Bill

Democrats and Republicans making up a third of the U.S. Senate back a measure proposed by Senator Byron Dorgan, a North Dakota Democrat, and Senator Olympia Snowe, a Maine Republican, that would allow Americans to buy drugs from Canadian and European pharmacies inspected and licensed by the FDA. The bill was endorsed by the 36 million-member AARP, the largest lobbying group of Americans age 50 or older. Senator Bill Frist, 52, the Tennessee Republican who is Senate majority leader, has opposed bringing the matter to a vote.

While drugmakers and Bush oppose imports as unsafe, Bush said in his Oct. 13 debate with Kerry that he was trying to secure flu vaccine from Canada to allay a shortage in the U.S.

``That's kind of a mixed message,'' said Larry Sasich, a researcher and pharmacist for Public Citizen, a Washington-based consumer advocacy group. Flu vaccine is available in Canada at about $2 a dose, compared with $8 to $9 in the U.S., he said.

To contact the reporter on this story:
John Lauerman in Boston at [email protected].

To contact the editor responsible for this story:
Robert Simison at [email protected].

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