FDA Warns U.S. Site Selling Canadian Prescription Drugs

The Food and Drug Administration (FDA) Tuesday issued a warning letter to a Detroit-based firm operating an Internet and mail order business selling Canadian prescription drugs. The FDA claims CanaRx Services, Inc., is operating an illegal business and is a risk to public health.

The letter states that CanaRx Services is causing the shipment of prescription drugs from a Canadian pharmacy into the U.S., subjecting Americans to “risky imported drug products and making misleading assurances to consumers about the safety of its drugs.”

According to the FDA, CanaRx Services states incorrectly to consumers that their prescriptions are “FDA approved” or uses similar language which could lead consumers to conclude mistakenly that the prescription drugs sold by the company have the same assurance of safety and effectiveness as drugs actually regulated by the FDA.

The FDA says it has evidence demonstrating that CanaRx shipped insulin, a product that should be stored under refrigerated conditions, in a manner that did not ensure adherence with the storage conditions specified in FDA approved labeling, potentially compromising the safety and effectiveness of the insulin.

“Firms like this should not continue to profit through illegal actions that put the health of the American public at risk,” said Dr. Mark B. McClellan, M.D., commissioner of the FDA. “Our investigation has shown that CanaRx operates a drug purchasing arrangement that channels drugs through companies other than licensed pharmacies and does not consistently use shipping practices that ensure its drugs are safe and effective.”

Last October, as fears of anthrax swept the nation, many Americans turned to the Internet to find foreign websites promoting and selling anthrax antibiotic ciprofloxacin (Cipro). The drug, which requires a prescription, prompted the FDA to issue warning letters to websites selling the unapproved and non-prescribed doses of Cipro.

While the anthrax scare has died down, government concerns over “rogue” online pharmacies continue as sites not licensed to dispense prescriptions push drugs such as Viagra and Propecia. Some sites blatantly advertise that no prescription is required. In other cases, the consumer is told to respond to a brief questionnaire and then a “doctor” provides a prescription for the requested drug, which is then mailed to the consumer.

According to the government and legally licensed online pharmacies, the illegal Web drug stores bypass not only regulatory safeguards, but also the safeguards that are inherent in a legitimate doctor-patient relationship. They argue that consumers obtaining medications from the rogue pharmacies place their health at risk.

Some consumer groups, however, contend that the high cost of prescription drugs force people to the illegal sites. With the cost of prescription drugs increasing by double digit percentages every year, seniors on fixed incomes, for instance, are often faced with difficult financial decisions. The rogue pharmacies are seen by many as the only way to afford to prescription drugs.

Although many legitimate Internet pharmacies provide safe access to prescription services, foreign Internet pharmacies selling to the U.S. operate outside the law.

The FDA says it appears that CanaRx is not a licensed Canadian pharmacy subject to regulatory oversight, and so may place patients at additional risk.

CanaRx has 15 working days to respond to the FDA’s warning letter. The FDA says it will take appropriate action, including collaborative actions with individual states and foreign governments, to stop similar illegal activities by CanaRx or other similar firms.