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FDA offers 'lighter touch' on drug imports

/ Source: The Associated Press

Federal drug regulators are using a "lighter touch" in their efforts to stop a growing number of cities and states from importing prescription drugs from Canada, and the city of Boston is taking advantage of that new posture.

Acting Food and Drug Administration Commissioner Lester M. Crawford, in a recent interview with the Associated Press, said the agency will continue to evaluate programs on a case-by-case basis. But he noted that many cities and states are using the same Canadian pharmacies and Web sites to fill prescriptions.

"As long as they're coming from Canada, and as long as they're from drugstores that we have some experience with, then we would have a lighter touch probably," Crawford said. "But if it escalates and there are other countries, or if there are some events that occur, that could change over night."

Sensing an opening, the city of Boston is forging ahead with its pilot program allowing city workers and retirees to get cheaper drugs from Canada, despite a warning letter from the FDA.

Mark Reynolds, special assistant to Boston Mayor Thomas Menino, said Monday the city will continue to use Total Care Pharmacy of Calgary, Alberta, even though the FDA warned against it in an Aug. 4 letter. Issues brought up in the letter are no longer a problem, Reynolds said, and Wisconsin has been using Total Care and is very happy with the program.

The FDA letter used "what might be considered a lighter touch," said Reynolds. "The letter said they recognized that pricing was an issue, and they wanted to work cooperatively."

Canadian drugs still illegal

The FDA has consistently told city and state officials that importing drugs from Canada is illegal and unsafe. But the agency has done little to stop governments that set up programs, preferring to send warning letters and hold meetings to stress the risks involved.

Instead, the agency has tried to crack down on illegal drug importation companies in the United States, and urged Canadian authorities to be more aggressive on their side of the border.

Crawford said the FDA would probably only take legal action through the courts "in the event of a public health event or one that we think is imminent." The agency would also become more concerned, he said, if states began importing drugs from countries other than Canada.

The FDA will not approve any pilot programs for importation of Canadian drugs, he said. Meanwhile, Vermont said it will sue the FDA for denying its request to import prescription drugs from Canada.

Crawford said the agency has not decided whether to vigorously defend itself against the lawsuit.

Boston is the largest city to offer Canadian drugs as an option; Springfield, Mass., and Montgomery, Ala., have had similar programs for about a year.

In the letter to Menino, FDA Associate Commissioner William Hubbard warned that Total Care violated its contract with Wisconsin by dispensing generic drugs that had no approved version in the United States. Reynolds said Wisconsin officials explained the problem was with the contract, and everything is now settled.

Boston launched its program last month. Employees are in the process of filling out applications, and city officials expect people to begin submitting prescriptions this week.