FDA seeks action to halt importing as states eye Canada for savings

Drug Store News, Sept 22, 2003 by Michael Johnsen

WASHINGTON -- The Department of Justice sought an injunction against Rx Depot earlier this month, at the request of the Food and Drug Administration following through on a warning letter issued in March to the storefront operation that facilitates the illegal import of Canadian medicines.

"We cannot and will not stand by and let aggressive companies prod through illegal actions that put the health of Americans at risk," sate FDA Commissioner Mark McClellan.

The Justice Department has since contacted Rx Depot and ordered the storefront chain to close it doors or face legal action. The complaint will be filed in the United States District Court in the Northern District of Oklahoma and will seek to enjoin Rx Depot and individual officers from directly or indirectly importing Canadian medicines into the United States.

Carl Moore, president and founder of Rx Depot, has stated publicly that he will fight the Justice Department and the state boards of health in the three states that are trying to shut his operations down.

Not all government agencies are looking to stop operations such as Rx Depot, however. California, for instance, sought advice from the Food and Drug Administration before going ahead with a plan to import drugs. In response, William Hubbard, associate commissioner for policy and planning at the FDA, sent an eight-page letter in August to Deputy Attorney General Gregory Gonot of California explaining in detail why the Golden State could not import Canadian medicines safely or legally.

Also last month, legislation was drafted in Massachusetts that, if passed, would allow state institutions to facilitate the illegal import of pharmaceuticals from Canada.

"It's time to use the free market to keep millions of dollars in the pockets of tax payers and out of the bank account of the wealthy pharmaceutical companies," stated Sen. Jarrett Barrios lead sponsor of the Massachusetts amendment to S. 494, the Prescription Drug Price Reduction Act.

"Consumers are increasingly turning to the Internet to find cheaper drugs, yet there is no source to tell them which ones they can trust," added John McDonough, executive director of Health Care for Massachusetts. "This legislation would give them a place to team about reputable Canadian sources."

Barrios has told reporters that he will push to have the act considered by the full Massachusetts legislature this fall. If it passes, the measure would direct Governor Mitt Romney to seek a waiver from the federal government to allow state officials to distribute information on how to order drugs from Canadian pharmacies.

Nevertheless, the bill does not address the actual safety of those imported medications. Neither the FDA nor its Canadian equivalent, Health Canada, will guarantee the safety of the illegally imported drugs. If consumers are harmed by the Canadian imports, it's unclear whether they would be even able to seek redress in U.S. courts given the liability waiver forms they sign to access Canadian drug imports.

Barrios told Drug Store News that the Prescription Drug Price Reduction Act would address safety issues by allowing only FDA-approved medicines into Massachusetts. In other words, the waiver would only cover those drugs that were manufactured in an FDA-approved facility that were then shipped to Canada (and consequently shipped back into the United States).

"What it would require the state to do is develop a system of making available to consumers information--whether it's through the state directly or via local pharmacies or third parties--about how people can purchase FDA-approved drugs [from Canada], he said.

In that regard Massachusetts-based American pharmacies would be able to facilitate that import of medicines from Canada as well, so that they would not lose the prescription business altogether to the Canadian operations. That, said Barrios, "is how you prevent the small drug store owner from losing business in the long term."

Asked who would police the numerous Canadian pharmacies that currently export medicines to the United States to make sure they were in fact dispensing only drugs that were once "FDA-approved," Barrios said that was a role Massachusetts would fill, directing consumers to patronize compliant Canadian pharmacies. "It would allow us to assure our public that if you're going through this route, you re actually safe," said the state lawmaker.

Massachusetts would rely on the Canadian pharmacies to self-report whether the medicines they export to the state were originally manufactured in an FDA-approved facility and to FDA standards, Barrios noted.