The U.S. Food and Drug Administration has issued a warning letter to Canadian drug company CanaRx Services, citing the pharmaceutical importer for "the introduction of unapproved new drugs and misbranded drugs," and claiming that, "These drugs are potentially dangerous to U.S. consumers."
The FDA is concerned that CanaRx is distributing products which have not been approved for use in the U.S., or which have been “misbranded.” When the FDA chooses to label a product as misbranded, this typically means it does not contain proper directions for usage or proper warnings related to potential side effects.
CanRx assists U.S. citizens in purchasing medicines they might not be able to obtain otherwise form pharmacies in Canada, Australia, and the United Kingdom. Their program offers hundreds of well-known and mainstream drugs which are prescribed for various conditions and diseases, including hepatitis, cancer, HIV, and more.
Counsel for CanaRx, Joseph Morris, has fired back against the FDA’s description of its business model, stating, "The CanaRx program does not involve new, experimental, unapproved or misbranded medications. Rather, CanaRx works for individual American patients who wish to exercise their rights of personal importation, as permitted by law and by the FDA's own handbooks.” Morris goes on to describe this process in detail, elaborating on how, “CanaRx facilitates foreign physicians rewriting of the employee's valid U.S. prescription, and then supplies the employee with approved versions of FDA-approved drugs that have been sourced from Canada, the United Kingdom or Australia where they have undergone review from those countries' drug regulatory systems.”
However, while Morris did push back on the FDA’s description of their program, he did note that he understood where their concerns were coming form, saying, "CanaRx believes that the FDA is trying to prevent Americans from being injured by unregulated suppliers of counterfeit and other dangerous substances.” Morris’s statement concluded that “CanaRx agrees with the FDA's goals."
According to the warning letter sent by the FDA, the issue is that many of the drugs CanaRx is bringing into the United States are extremely strong, given the often serious conditions they treat. They may also have different dosages or trade names based on the manufacturers, making them even stronger than similar drugs patients might get in the United States. "Such differences can cause patient confusion and lead to medication errors," claims the FDA. They also noted that more than 150 websites are associated with CanaRx, creating further chances for confusion.
The FDA issued its warning letter following an extensive review of CanRx’s practices. FDA Commissioner Dr. Scott Gottlieb detailed some of the administration’s concerns with these in a press release, warning that, "When a consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded. While operations or illegal online pharmacies may state on their websites that its medicines are coming from Canada, the United Kingdom, Australia, etc., this is not necessarily always the case.”
Gottlieb also alleged that illegal online pharmacies may take advantage of American consumers, advertising that the drugs they import are safe and effective, when in reality patients end up getting medication that is fake, expired, mislabeled, or has been recalled. According to Gottlieb, "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.”
Gottlieb voiced concern that CanaRx is distributing drugs which the U.S. has higher safety requirements for as well. According to the FDA Commissioner, the administration employs “risk mitigation” programs to ensure that the safety of patients is protected at all costs. This means that drugs being imported which are safe for some may not be safe for everyone. As Gottlieb and the FDA see it, CanRx is ignoring the individualized needs of patients, whose doctors may not want then to be taking medication that is largely untested and unregulated.
The FDA warning concludes by telling CanRx to cease and desist all sales of unapproved and misbranded drugs. CanaRx has said they "will respond promptly, fairly and fully to the FDA." In the meantime, however, American consumers who have used the CanRx program are forced to wait, in the hope they have not been negatively affected by any products they purchased.
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