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9/10/2003

Federal Government Takes Action Against Storefront Pharmacy

Donna Young

The Food and Drug Administration (FDA) yesterday announced that it has asked the Department of Justice to file an injunction against a company that is assisting U.S. consumers in obtaining prescription drugs from Canada.

The Justice Department warned Rx Depot of Tulsa, Okla., that it has until tomorrow to close its 85 storefront operations or be sued, according to the Associated Press, which claimed to have a copy of the Sept. 9 warning letter.

The injunction would be filed in the United States District Court in the Northern District of Oklahoma, according to FDA, but an agency spokeswoman said that the Justice Department had not specified how soon it would file the suit.

FDA warned Rx Depot in March that the company's actions "present a significant risk to public health" and that Rx Depot had been misleading the public about the "safety of the drugs" obtained through the company.

Every shipment of prescription drugs from Canadian pharmacies to consumers in the United States violates the Food, Drug, and Cosmetic Act, the agency stated in its March 21 warning letter.

"The reason that Canadian or other foreign versions of U.S.-approved drugs are generally considered unapproved in the U.S. is that FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance," FDA said.

Rx Depot's Web site posts a disclaimer that "Canadian medications are not FDA approved, however they do meet [Canada's Health Products and Food Branch] standards."

FDA Commissioner Mark B. McClellan told National Public Radio on Sept. 4 that "When you go into a drugstore in Canada you can be very sure that the drug that you're getting is safe and effective and it's going to work the way that it is advertised to work. The problem is, when people buy over the Internet or from other long-distance sources, there aren't safeguards in place to make sure that the drugs are handled properly, or labeled properly, and are delivered properly to the people who are getting them. There are some real safety problems."

Patients fill prescriptions through Rx Depot by taking an order to one of the company's storefront operations or by completing an information form from Rx Depot's Web site and faxing it along with the prescription to one of the company's locations.

The patient's prescription and information form are sent to a Canadian pharmacy, which then obtains a similar prescription from a Canadian physician. Canadian drug products are then shipped by a pharmacy to the U.S. consumer.

Rx Depot's Web site compares prices of drug products advertised on U.S. pharmacy Web sites to those purchased in Canada.

A patient purchasing 100 tablets of cyclooxygenase type 2 inhibitors or cholesterol-lowering products would pay about $100 less in Canada than what a consumer would pay for the same products in the United States, according to Rx Depot.

FDA said yesterday that despite its warning to Rx Depot, the company has stated that it will continue its activities "until ordered by a court to stop."

Rx Depot President Carl Moore told the Wall Street Journal in an article reported today that he was "not doing anything illegal and we're going to prove it in a court of law."

FDA said that during the course of an investigation into Rx Depot's practices, agency investigators made undercover purchases from the company's Oklahoma operation of two products, including a 30-day supply of nefazondone hydrochloride, an antidepressant marketed by Briston-Myers Squibb under the brand name Serzone.

Instead of the 60 tablets prescribed, "the investigator received 99 tablets of APO-Nefazodone, an unapproved, foreign-manufactured version of the active ingredient in Serzone," according to FDA.

The APO-Nefazodone package, the agency said, did not indicate that more than the prescribed number of tablets was sent, but instructed the patient to take one tablet two times a day.

"If the patient took the drug as instructed by the package sent from the Canadian pharmacy, he or she could have an increased risk of liver failure, which might be associated with taking the drug for an excessive period," FDA declared.

Oklahoma, Arkansas, and Montana have also taken action against Rx Depot.