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U.S. Moves to Halt Import of Drugs From Canada
By
Gardiner Harris The
New York Times, September 10, 2003 The Justice Department moved yesterday to close a chain of Canadian drugstores, signaling that federal regulators are cracking down on the import of cheaper drugs from abroad. Carl Moore, president of the drug chain, Rx Depot, remained defiant. Rx Depot allows patients to order prescription drugs from Canada at prices often half those in the United States. "We're not going to stop, and we're going to fight for the right of senior citizens to buy affordable medicines," Mr. Moore said. His company, which also operates under the name Rx of Canada, has 85 stores in 26 states, with more opening monthly. Pharmaceutical manufacturers are fiercely opposed to the stores and have been pushing federal drug regulators to take action against them for more than year. Until yesterday, the Food and Drug Administration had taken only tentative steps, and state efforts had been spotty. As a result, Rx Depot and similar chains have been spreading like kudzu. With information from the F.D.A., the Justice Department sent a letter yesterday to Mr. Moore promising that it would seek an order in federal court to shut the company, the largest of these storefront chains, unless it agreed by Thursday to close. The United States is the last industrialized country that allows drug makers to set prices. Drug prices here are on average twice those in Canada and nearly three times those in Italy, according to a recent report by a Canadian health agency. The drug industry argues that it must charge high prices to pay for expensive research and that price restrictions in the rest of the world should be lifted rather than allowing those drugs to be imported into the United States. But the growing gap between American drug prices and those abroad has caused cross-border prescription drug sales to soar to as much as $650 million annually, according to IMS Health, a company that tracks drug sales. Some older people take monthly bus trips to Mexico and Canada to buy drugs. Others order drugs from Canadian pharmacies with Web sites. But with computer familiarity limited among the elderly, entrepreneurs like Mr. Moore opened stores to help patients order drugs online. Regulators largely ignored the cross-border trade as long as it was occasional bus trips and private Internet orders. But storefronts indicated that an entire industry had sprung up in defiance of a United States law banning drug imports. Pharmacists complained that the stores lacked pharmacy licenses or licensed pharmacists and could sell the same products for much less. State pharmacy boards in Alabama, Arkansas and Oklahoma began to crack down on the stores, arguing that they were dispensing prescriptions without appropriate state licenses. Some other state pharmacy boards decided to leave the matter to the Food and Drug Administration. "In some states, there is no political support to go after Rx Depot," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. The drug industry and drug regulators say that imported drugs are more susceptible to counterfeiting than those sold in the United States. The F.D.A. said yesterday that one of its investigators had ordered a 30-day, 60-pill prescription of the antidepressant Serzone from an Rx Depot but instead received a bottle with 99 pills. Serzone can, in rare instances, cause serious liver damage, and the F.D.A. argued that the larger number of pills could pose a risk. "Unapproved drugs entering the United States through illegal channels pose a significant threat not only to good prescribing practices but to the safety and security of the prescription drug supply," said Mark McClellan, an F.D.A. commissioner. Some in Congress favor drug imports. An amendment to legislation in the House creating a Medicare drug benefit would legalize drug imports. Representative Gil Gutknecht, a Minnesota Republican, and a sponsor of the amendment, said in an interview that no one had been hurt by such sales. Even without the help of federal regulators, drug manufacturers have begun to limit their own sales to Canadian pharmacies in an effort to halt the growth of imports.
Copyright
© 2002 Global Action on Aging
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