FDA issues warning to CanaRX over “unapproved and misbranded drugs”

According to a FDA press release, a warning letter has been issued to Canadian medicine distributor CanaRX over the “introduction of unapproved drugs”, and for selling “misbranded drugs” to US consumers.

In the warning letter, the FDA says that some of the drugs that are available to consumers aren’t approved by the FDA, or they include warnings or directions that are considered to be inadequate.

This could be dangerous to consumers, and the agency has warned that CanaRX needs to stop distributing unapproved drugs to avoid further action.

FDA Commissioner Dr. Scott Gottlieb said in the press release: “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.

“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.”

“These risk mitigation programs are a legal requirement and are in place for important safety reasons. Sidestepping them is unacceptable and puts the safety of patients in great jeopardy.”

CanaRX provides medication to consumers – often including prescription drugs and including many commonly used brands. This includes drugs to treat cancer and HIV.

The FDA says that some of these drugs could have been recalled and CanaRX is putting consumers at risk by continuing to sell them.

In a statement, Joseph Morris, representative for CanaRx Services, said: “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.”

“Every prescription that is dispensed through a CanaRx program is dispensed directly to the patient from a licensed, regulated, brick-and-mortar pharmacy in Canada, the United Kingdom, or Australia, and the patient can be sure that the medicine she receives is the medicine the doctor ordered.”