US Department of Justice threatens Tulsa-based Rx Depot, orders them to close its stores
Tuesday, September 9th 2003, 12:00 am
News On 6
MIAMI (AP) _ The Justice Department ordered Rx Depot, which is based in Tulsa, to close up shop, as the Bush administration for the first time moved to shut down one of the numerous chains of Internet stores that promise to sell senior citizens cheaper drugs from Canada.
In a letter Tuesday to Rx Depot's president Carl Moore that was obtained by The Associated Press, the DOJ said it would sue Moore unless he agrees by Thursday to shut down the company's 85 storefronts. The Justice Department said the stores violate federal law by helping U.S. consumers import drugs from Canada; only manufacturers are allowed to bring medicines into the country.
Moore said in an interview that he had no intention of signing the agreement.
``Just because this is the federal government, this does not scare me,'' he said. ``I look forward to my day in court.''
Charles Miller, spokesman for the Justice Department's civil division, called the letter ``an attempt to have them stop their illegal activity and settle this matter.''
``We have not heard directly from Rx Depot, and if they are interested in a settlement, then we will pursue a settlement,'' Miller said. ``If they are not interested, we will pursue litigation.''
Moore has raised the ire of the pharmaceutical industry and regulators by helping seniors get prescription drugs from Canadian pharmacies, which are often priced 50 percent below U.S. drugstore prices because of Canadian government regulations.
The Food and Drug Administration warned Rx Depot in March that it was illegally importing drugs from Canada, and to quit or risk being shut down. Rx Depot not only refused, it actually expanded operations into more states, said FDA Associate Commissioner William Hubbard.
The FDA said it asked the Justice Department to seek an injunction against Rx Depot ``to stop them from importing drugs that pose a serious threat to the public health.''
Rx Depot is far from the only offender, Hubbard said: The FDA is preparing warning letters for seven Web sites that purport to sell cheaper Canadian drugs to Americans.
The FDA said the companies aren't just violating the law, but also endangering the health of customers.
``FDA has uncovered a disturbing pattern of actions by these companies resulting in potentially hazardous errors,'' the agency said in a statement posted on its Web site later Tuesday.
For example, in the Rx Depot case, FDA agents posed as customers and ordered Serzone, a powerful antidepressant, from Rx Depot. The company promised that it would ship a U.S.-made, FDA-approved bottle of the drug. Instead, Rx Depot shipped to FDA what appeared to be a counterfeit copy of Serzone, made in some country other than the United States or Canada, Hubbard said.
``It is not Serzone. It's not an approved drug in any way,'' he said.
In the cases pending against the Web site operators, FDA officials bought Accutane, the acne drug that can cause serious birth defects. U.S. women of childbearing age can only get Accutane after they are tested to ensure they're not pregnant.
None of the seven Web sites that shipped FDA Accutane even warned customers about birth defects, much less asked about pregnancy, Hubbard said. And some of the mailed drug appeared counterfeit, he added, saying testing to verify that is under way.
``Those are the real-world examples we see with these drugs, as opposed to what we hear about advocates saying, 'It's a good drug, just cheaper.' We see the safety not being there,'' Hubbard said.
Rx Depot, based in Tulsa, Okla., operates storefront businesses in half a dozen states including Florida, Oklahoma and Arkansas. Pharmacy regulators from four states have attempted to close Moore's stores in their states. Only Montana has succeeded.
Since the beginning of the year, four drug companies have started to limit the amount of drugs they ship to Canada in hopes of choking off supplies to companies that sell the drugs back to Americans.
Also this week, the FDA alerted health regulators in Canada that some of their pharmacies were shipping foreign-made drugs that purport to be Canadian-made, Hubbard said.