The U.S. Food and Drug Administration posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. These drugs are potentially dangerous to U.S. consumers.
The warning letter is the result of a lengthy review of the company’s violative practices. The letter expresses the FDA’s concerns with the scheme CanaRx uses to contract with public and private entities to provide prescription drug coverage to their employees. 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.