FDA Says Survey Raises Red Flags on Canadian Pharmacies

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

Citing the review, 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 health minister in Canada.

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

The FDA contends that it cannot guarantee the safety of imported drugs, and it has been working to discourage states and others from importing the medications.

McClellan cited violations such as a pharmacy using a technician, instead of a trained pharmacist, to enter a prescription; drugs that require refrigeration being shipped unrefrigerated; and pharmacies dispensing “grossly improper amounts” of medications.

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

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

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

In November, Health Canada’s Gorman took issue with the suggestion that the pharmacies were 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 were concerned that the 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 website 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.”

He noted that people are already buying drugs from Canada.

“We feel that it’s our state obligation to step in and do site visits and provide for some safety mechanisms for the people that are purchasing these drugs,” he said.