FDA warns CanaRx to stop distributing ‘unapproved, misbranded’ drugs
The FDA recently posted a warning letter to CanaRx requesting it immediately stop dispensing “unapproved new drugs” and “misbranded, potentially dangerous drugs” to U.S. consumers.
The letter references the hepatitis-indicated drug Baraclude; the organ rejection-indicated drugs CellCept and Zortess; the asthma and COPD-indicated drug Foradil; the cancer-indicated drugs Gilotrif, Gleevec, Inlyta, and Stivarga; the HIV-indicated drugs Invirase, Norvir, Reyataz, and Truvada; the epilepsy and nerve pain-indicated drug Tegretol; the pulmonary arterial hypertension-indicated drug Tracleer and more than 150 websites affiliated with CanaRx.
According to the FDA, many of the drugs involved in CanaRx’s scheme bypass the FDA’s REMS procedures. The FDA also alleges CanaRx contracts with public and private organizations to provide prescription drug coverage to their employees, oversees 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 release states.
"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," FDA commissoner Scott Gottleib, MD, said in the release. "To protect patients from these unapproved drugs, we urge employers and any enrolled employees not to use any medicines from CanaRx."
The warning letter also requests that CanaRx respond within 10 working days with details of how it intends to correct the violations noted in the warning letter. Any violations not corrected in the warning letter could lead to enforcement action, the release stated.
Healio Primary Care Today could not reach CanaRx for comment prior to this story’s posting.
Disclosure: Gottlieb is FDA commissioner.