FDA Tells Canadian Drug Store Fronts To Cease and Desist

September 10, 2003 (PLANSPONSOR.com) - The US Department of Justice has issued a warning to Rx Depot and its partner Rx of Canada to comply with an order to shutter their Canadian drug-supplying doors or face possible court action.

The Justice Department’s warning is the latest escalation of the US government’s war on “storefront pharmacies,” companies that act as a facilitator between US prescription drug receipts and low-cost Canadian pharmacies. This allows the drugs to be mailed directly to consumers while the storefronts receive a commission, according to a USA Today report.

Pointing the Justice Department in the direction of the two Oklahoma-based companies was the US Food and Drug Administration (FDA), which gave Rx Depot and Rx of Canada 48 hours to shutter their doors, or face the possible wrath of the Justice Department. However, Rx Depot President Carl Moore says his firm will fight the government’s effort. “What we’re doing is legal in every way,” says Moore, whose firm received a warning letter from the FDA in March.

Covert Ops

The Food and Drug Administration says the stores violate federal law barring drug importation and pose risks that drugs shipped will be expired, counterfeit or mishandled. However, store advocates say buying from Canadian pharmacies is safe and often the only alternative for low-income customers.

As proof of its contentions, the FDA says it recently made two purchases from Rx Depot, one for an antifungal drug and one for antidepressant Serzone. Instead of Serzone the FDA was sent what it called an unapproved drug, the generic Apo-nefazodone. No generic is on the market in the USA. But Canadian health authorities have approved nefazodone, which is made by Canadian firm Apotex.

“The message here is that these storefront pharmacies lure patients to buy what are alleged to be good, safe American drugs and they send them something else,” says William Hubbard, associate commissioner of the FDA.

This is not the first time the FDA has conducted a sting operation on an American company purchasing Canadian prescription drugs. Last month, the FDA allegedly caught the supplier of Springfield, Massachusetts’ Canadian drug shipments red handed in the improper handling of insulin, saying when the insulin arrived via regular mail, it was at room temperature, instead of chilled and delivered via overnight mail as it is supposed to be handled to ensure its effectiveness (See FDA Stings Springfield’s Canadian Drug Supplier ).

That sting operation, represented the latest move in the chess-match battle between the city of Springfield and the FDA. In August, the FDA Commissioner Mark McClellan urged the city to reconsider its prescription drug plan, fearing that by purchasing from Canada, participants were putting their lives at risk (See FDA Calls Out Springfield Canada Drug Buying Plan ).