FDA Cracks Down On Canadian Drugs

The government told an Arkansas mail-order drug company Friday that it is illegally importing cheaper medicines from Canada, the first step in an anticipated crackdown on the growing trend.

Importer Rx Depot pledged to fight the action in court.

Americans have long flocked to Canada to fill prescriptions that can cost less than half the drugs' U.S. price.

But what began as patients crossing the border to buy their own drugs has turned in the past year into a booming Internet and mail-order business that supplies Americans who never leave home. It's an industry often run through small storefront operations that are cropping up around the country.

The Food and Drug Administration never has targeted patients who buy cheaper drugs abroad and bring them home. But the FDA warns patients that there's no guarantee the imported drugs are the same as U.S. versions, even if they bear the same name.

Indeed, the agency is investigating whether some imported drugs were made in poor countries instead of being the Canadian version customers were promised.

Drug sales are required by law to be conducted by licensed pharmacies, and importing even U.S.-made and -approved drugs from abroad for resale in the United States is illegal. Last month, the FDA put such importers, and insurers who pay for imported drugs, on notice that anyone aiding that practice could face legal action.

Friday, the FDA targeted the first such U.S.-based importer, Rx Depot Inc. of Lowell, Ark. In a warning letter, the FDA said the company not only violated federal drug-importation laws, but it lied to customers on a Web site that falsely said the drugs were approved by the FDA.

Rx Depot operates nationwide, over the Internet and in storefront operations in half a dozen states.

Although the FDA letter targeted only the Arkansas location, "they're violating federal law wherever they're operating," said FDA associate commissioner William Hubbard.

The letter gives Rx Depot 15 days to defend itself before the FDA can take other action to stop sales. The FDA said Arkansas pharmacy regulators had notified the company it was violating state law.

If the Arkansas warning doesn't prompt nationwide compliance, the FDA can target the company state-to-state, he said.

Rx Depot has 15 days to defend itself before the FDA can take other action to stop sales. The FDA said Arkansas pharmacy regulators also had notified the company it was violating state law.

But Rx Depot President Carl Moore vowed to challenge the FDA in court, saying his company is providing a crucial service for hundreds of customers around the country who otherwise couldn't afford treatment.

"We're very opinionated and impassioned about what we're doing and why we're doing it, and we're not going anywhere," Moore said.

Moore said his customers are shipped drugs from a licensed Canadian pharmacy, in the same packages as U.S. manufacturers sell them here, so there are no safety concerns.

Moore said his son, World Cup soccer player Joe-Max Moore, started the company after his mother was able to buy tamoxifen to treat her cancer in Canada for a fraction of the U.S. price.

Congressional Democrats recently urged the FDA to do nothing that would block consumers from buying Canadian drugs.

"There's never been one shred of evidence, in my committee or anywhere else, that the Canadian drug safety process is not as rigorous as ours," said Rep. Sherrod Brown, D-Ohio, who co-wrote that letter. He accused the Bush administration of bowing to pharmaceutical companies who provided tens of millions of campaign dollars.

The FDA has long told Congress, however, that the imports could be riddled with counterfeit products. In congressional testimony last summer, U.S. Customs agents told of intercepting mailed pills that contained sugar instead of medication and others that bore an expiration date of 1980.

FDA's focus is on suppliers, not patients, Hubbard stressed, although U.S. officials are now distributing brochures to busloads of patients on Canadian drug-buying trips that say, "'you're taking a chance with these drugs."'

By Lauran Neergaard