FDA Issues Warning to CanaRx

On Feb, 26th, the FDA issued a warning letter to Canadian-based online pharmacy CanaRx, demanding that it cease and desist its illegal importation activities.

CanaRx, as alleged in the public letter, works with U.S-based employers to fill prescriptions for employees from foreign physicians and pharmacies. Though originally prescribed by U.S. physicians, the prescriptions are reissued by physicians in Canada, the United Kingdom, or Australia. The prescriptions are then filled at a pharmacy in the physician’s jurisdiction, before being  mailed directly to the U.S. consumer.

The FDA suggests these drugs may have different dosage strengths, may have been manufactuered differently or by altogether different manufactuerers, and could even be from batches that were expired or recalled from American markets. 

“The FDA’s regulation and oversight of the drug approval process and distribution protects consumers by requiring rigorous scientific standards, labeling review for accuracy and completeness, and helping to ensure that counterfeit and unsafe drugs do not penetrate the U.S. drug supply, among other things. When companies sidestep important drug safety measures and put patient health at risk by providing unapproved drugs that have been substituted for FDA-approved prescription drugs, it’s the agency’s responsibility to step in to protect the patients,” FDA Commissioner Scott Gottlieb, MD said in a press release.

U.S consumers have increasingly sought prescription drugs from online foreign sources, despite the differences in regulatory oversight; however, the health risks may not be worth the lower price.

The FDA is also explicitly states that it is aware of recurrent importation activities, but "rarely objects to personal imports of drugs that FDA has not approved under certain circumstances.”