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Date Posted: 06:32:15 12/19/03 Fri
Author: Don Chambers
Subject: FDA fails to dissuade Menino on Canada-drug plan
In reply to: Bennie 's message, "Canada: New Hampshire to put Canadian drugs mere click away for its residents" on 08:48:56 12/12/03 Fri

FDA fails to dissuade Menino on Canada-drug plan
Menino sticks with Canadian-drug plan
By Christopher Rowland, Globe Staff, 12/19/2003

Shrugging off warnings from the Food and Drug Administration yesterday, Boston Mayor Thomas M. Menino said he will forge ahead with his pilot plan to import prescription drugs from Canada for city employees and retirees.

The mayor traveled to Washington and sat down with a group of high-ranking officials at the FDA who urged him to abandon his plan because of safety concerns and potential liability exposure for the city. Menino said in a telephone interview later that the conversation ended on a cordial note but that he disagreed with most of the FDA's points.

"We're on the right side," Menino said. "If we don't get relief from the FDA and the Department of Health and Human Services, we have to go someplace else, and that someplace else is Canada."

Menino also brushed aside as "a bogus argument" fresh warnings from the principal industry organization representing 25 large Canadian Internet pharmacies. The group, the Canadian International Pharmacy Association, called on American mayors and governors this week to refrain from importing drugs for employees because thousands of new customers would overwhelm available drug supplies and could trigger a Canadian government crackdown on the cross-border trade.

But Menino said the issue is a "red herring" that has been introduced by drug makers to sow shortage fears in Canada. He expressed confidence that Boston could overcome any supply problems, given that the Canadian government has not found evidence of shortages thus far.

Brand-name drugs in Canada are typically identical to the drugs in America, but they can be 20 to 80 percent cheaper because of Canada's price controls. Menino said last week he would kick off a program for 7,000 city employees and retirees that would save $1 million a year beginning July 1.

Menino and FDA officials said they agreed to meet again to offer comments as Boston's plan takes shape, but an FDA official said the agency remains skeptical that Menino can fashion a program acceptable to the government.

"We can't see in our mind where a city or a state can design a program that can provide safe and effective drugs from illegal foreign sources," said Peter Pitts, FDA associate commissioner for external relations. The FDA says allowing imports from another country opens a channel for counterfeit, expired, or tampered drugs.

Although Boston's program will almost certainly run afoul of federal law, which makes it illegal to import drugs that have not been approved by the FDA, there are no indications that the FDA would take any action to block it.

Springfield Mayor Michael Albano has been operating the only government-sponsored purchasing plan for public employees since July, and the FDA has not taken any steps to shut it down.

Boston is in the vanguard of cities and states contemplating a Canadian option to lower the costs of drugs. It is joined by New Hampshire, which plans to launch a website next month that will provide references to reputable Canadian pharmacies and plans to buy drugs from Canada for its state prisoners and Medicaid recipients with mental illnesses.

The Canadian International Pharmacy Association's warnings about government-sponsored programs in the United States for employees drew criticism from G. Anthony Howard, the president of CanaRx Services Inc., an Ontario-based company that manages prescriptions and Canadian pharmacy drug orders for Springfield's municipal employees. "This is Canada working against Canada, and it's too bad," he said. He said the pharmacy association's members -- which do not offer that kind of benefit management services -- want to shove his government specialty business aside and soak up Internet business from those cities and states.

Also, Howard said, drug shortages are potentially more dangerous for the large Internet pharmacies, because they are more easily targeted by US drug companies looking to thwart cross-border trading. By contrast, CanaRx's contracts are with greater numbers of "bricks and mortar" pharmacies across Canada, which are harder to identify, Howard said.

David MacKay, International Pharmacy Association's executive director, said concerns about supply shortages in Canada are real.

Instead of bulk purchasing programs for public employees, the Net pharmacies favor state and city-sponsored websites like those planned for New Hampshire and Minnesota that would guide patients to safe, Canadian pharmacies. That way growth can be slowly absorbed without the sudden floods of new customers that would result from government employee programs, he said.

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  • Boston mayor vows to move ahead on drug imports -- Benny, 06:34:23 12/19/03 Fri
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