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Date Posted: 11:05:51 10/06/03 Mon
Author: Ernst Krenek
Subject: Re: Canada: Change in law prescribed for online pharmacies
In reply to: Jill 's message, "Canada: Change in law prescribed for online pharmacies" on 06:20:52 10/05/03 Sun

FDA sues Rx sellers to stop importation of drugs from Canada
The companies argue they are doing nothing illegal and that doctors send patients their way for affordable medication.
By Tanya Albert, AMNews staff. Oct. 13, 2003.

The government is cracking down on stores and Web sites that help American patients fill their prescriptions through Canadian pharmacies at lower prices than they could get in the United States.

The U.S. Dept. of Justice last month filed a lawsuit against two companies, Rx Depot Canada LLC and Rx Depot Inc., and the Food and Drug Administration sent a warning letter to a third, CanaRx Services Inc.

With this article
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FDA officials said they are concerned about the medications' safety. In its lawsuit, the government accused the two companies of breaking drug reimportation laws.

Company executives said that the medications are safe, sent from legitimate Canadian pharmacies that are under tight scrutiny from the Canadian government. They said their business practices don't break any laws.

"We are doing nothing illegal," said Russell Machover, owner of Rx Depot Canada. "They don't mind that people drive to Canada to fill prescriptions. If someone lives in Mississippi, they can't do that. We are helping facilitate someone in Mississippi to fill a prescription at a Canadian pharmacy."

Rx Depot Canada and Rx Depot Inc. are incorporated as separate businesses but are sister companies whose Web sites list nearly all the same 75 offices in 22 states. Rx Depot lists four additional locations that Rx Depot Canada does not.

Prescriptions in Canada are up to 70% cheaper than in the U.S.
The offices assist U.S. patients in sending prescriptions from their American physicians to Canada.

A Canadian physician reviews the prescription and information about the patient and rewrites the prescription. The Canadian prescription is then sent to a Canadian pharmacy that fills it and sends it directly to the U.S. patient. This allows patients to save up to 70% off of U.S. retail prices.

The shops have forced physicians in their communities to grapple with the issues of patient safety and access to drugs.

Marc Lewin, MD, a family physician in Charlotte, N.C., said some patients have asked him about Rx Depot since a storefront opened in his area a couple of weeks ago. Dr. Lewin practiced medicine in Canada between 1991 and 1994. Since that time, he's practiced in the United States.

"People's main concern is quality," Dr. Lewin said. "I can tell them, 'yes, the quality is there.' " But patients need to be certain they are dealing with a quality company doing the shipping, he said.

Dr. Lewin said he understands that the government needed to bring the lawsuit forward because business is being taken out of the country, but his main priority is his patients, especially those in Medicare.

"If there is a way for them to get medication safely for less money, I don't have a problem with it," he said.

The case against reimportation
The federal government sued both Rx Depot companies in U.S. District Court for the Northern District of Oklahoma.

The suit states that the reimportation of U.S.-manufactured drugs, even if approved for use in the United States, breaks the law because only drug manufacturers can reimport their medications to America. The government also charges that drugs manufactured in other countries have been delivered to U.S. residents.

"The defendants cause the importation of prescription drugs from Canadian pharmacies, which clearly violates the law and poses significant risks to the public health," the government said in its lawsuit. "Drugs that are imported from foreign countries do not have the same assurance of safety and efficacy as drugs that are regulated by the FDA."

Rx Depot and Rx Depot Canada officials said the companies will continue to operate during the legal proceedings. "Low-cost prescription drugs should be available to everyone in the country," said Machover. He added that he would be willing to volunteer to sit on a panel that would oversee businesses that link patients with Canadian pharmacies if safety is the government's concern.

Third Canadian company gets warning
In addition to the Justice Dept. lawsuit, the FDA in September issued a warning letter to executives at CanaRx Services, which through the Internet helps connect U.S. patients with Canadian pharmacies.

The letter notifies CanaRx that the agency believes the company is operating illegally. CanaRx President G. Anthony Howard said the company is removing all FDA references from its Web site but will continue to do business. The system works much like Rx Depot and Rx Depot Canada.

Howard said his business focuses on maintenance drugs and won't facilitate first-time prescriptions.

"Right from the get-go, we had nurses and secretaries from doctors' offices calling and asking what medications we offer," he said.

Machover said his company also has received a positive response from the health care community. "I have physicians who want to put these opportunities in their offices. We've been recommended by physicians, dentists, chiropractors."

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