April 22, 2019FDA News Release (02/28/19)

FDA issued on Thursday a warning letter to CanaRx, a Canadian drug distributor, for facilitating the distribution of unapproved new drugs and misbranded drugs to Americans. FDA Commissioner Scott Gottlieb said, "Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it's likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit. Importantly, they're also distributing drugs for which the FDA-approved versions are subject to additional safety requirements, such as special handling or specific safety requirements that apply when drugs are administered to patients (called REMS programs) because the risks associated with the medicines are serious and need to be carefully managed in order to protect patients." FDA's warning letter follows a lengthy review of the company's practices, and it calls into question the scheme CanaRx uses to contract with public and private entities to provide prescription drug coverage to their workers. FDA explains, "In the scheme, CanaRx facilitates foreign physicians rewriting the employee's U.S. prescription, and then supplies the employee with unapproved versions of FDA-approved drugs purportedly sourced from Canada, the United Kingdom or Australia that are represented to have undergone review from those countries' drug regulatory systems. This is particularly troublesome, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer's 'insurance' plan and may not question their legitimacy." The letter includes more than 150 websites affiliated with CanaRx, and it requests that the company respond within 10 business days of how it plans to correct the violations.

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