FDA to Canada: Crack down on Net pharmacies

WASHINGTON – Troubling questions about the safety of Americans who order medicines from Canada have been raised by a review of Canadian Internet pharmacies by Minnesota regulators, the commissioner of the U.S. Food and Drug Administration says.

Citing the review, FDA Commissioner Mark McClellan is urging Canadian officials to take more aggressive steps to regulate the pharmacies.

“Our concerns about the need for your assistance with such inspections were highlighted by the recent experience of officials from the state of Minnesota,” McClellan wrote this week to Diane Gorman, assistant deputy minister of Health Canada.

The Minnesota survey of eight Canadian Internet pharmacies, released this week, detailed safety violations at several of the pharmacies. The survey was done to help determine which pharmacies to include on a new state Web site that will offer access to low-cost Canadian prescriptions.

The FDA contends that it can’t guarantee the safety of imported drugs and has been working to discourage states and others from importing them.

McClellan cited violations that included:

. A pharmacy using a technician, instead of a trained pharmacist, to enter a prescription.

. Drugs requiring refrigeration being shipped unrefrigerated.

. Pharmacies dispensing “grossly improper amounts” of medications.

Minnesota’s commissioner of human services, Kevin Goodno, said McClellan failed to point out that the survey found one pharmacy, Total Care Pharmacy of Calgary, Alberta, which met or exceeded Minnesota’s standards in Minnesota, and three others that could meet those standards with minor modifications.

The state has selected one of those three, Granville Pharmacy of Vancouver, British Columbia, along with Total Care as the two pharmacies on its Web site.

A spokesman for Health Canada, Emmanuel Chabot, said the agency was still reviewing McClellan’s letter and declined to comment further.

Last November, Health Canada’s Gorman took issue with the suggestion that these pharmacies are unsafe.

“We have no evidence at this time, in the context of Internet pharmacies, that there are unsafe products going to the United States,” Gorman said then.

McClellan wrote that FDA officials are concerned that these pharmacies apparently “believe they can operate outside of the regulatory control of either of our nations.”

He said: “We very much need your assistance in assuring that appropriate inspections of these pharmacies are conducted and that enforcement actions are taken, to prevent the growth of unsafe practices.”

The FDA also hopes to use the Minnesota survey as ammunition against the state.

“We absolutely intend to be communicating with the state of Minnesota, because the people of Minnesota don’t deserve a Web site that represents the best of the worst,” FDA Associate Commissioner Peter Pitts said in a telephone interview.

The survey, he said, “calls to the public’s attention that these are very dangerous gray zones and that you can’t really trade some savings for safety.”

Goodno, the Minnesota Human Services commissioner, called that “an overstatement, and a fair amount of rhetoric is involved.”