On Thursday, the U.S. Food and Drug Administration (FDA) has warned CanaRx, a pharmaceutical distributor, that is endangering consumers by purportedly selling unsafe, unregulated, unapproved, and misbranded drugs.
CanaRx is a mediator between employer-sponsored health insurance plans and foreign pharmacies. As of 2017, the distributor contracted with over 150 public and private employers in 35 states, according to the FDA.
The pharmaceutical middleman accepts the employee’s prescription and a foreign physician rewrites the prescription through online consultation, which is filled with drugs from an unknown and unreliable source.
The drugs that are allegedly sourced from Canada are shipped directly to the employee with a disclaimer stating, “Depending on your country, our medications may appear to be different in size, shape or color.”
The FDA said that CanaRx’s medications, which include a wide range of drugs treating a variety of conditions such as HIV, cancer, hepatitis, organ rejection, epilepsy, asthma, and pulmonary hypertension, could be sub- or super-potent, contain unregulated ingredients, or may have been subject to recalls.
Dr. Scott Gottlieb, the FDA Commissioner, said, “Such operations and illegal online pharmacies take advantage of unsuspecting Americans by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit and that are provided outside of the closed American distribution system meant to protect patient safety.”
Consumers often trust the drugs that are sourced through their employer’s health insurance plan. To make things worse, they have no means of the resort if a drug harms them.
One of the drugs currently supplied by CanaRx is Tegretol. It has been found that small differences in dose or blood concentration for Tegretol can prove dangerous.
Erin Fox, the senior director of drug information at the University of Utah Health, said, “It makes sense that some small employers would contract with a company that likely markets their service as cheap and convenient given how high drug costs are.”
She also said, “This could be a big safety risk for some patients who are getting drugs that may be different than what the doctor actually prescribed. The prescription looks legitimate, but at end of the day it could be coming from a counterfeiting place in India or China.”
The warning letter issued by the FDA lists over 150 online pharmacies affiliated with CanaRx.
Some policymakers are requesting to allow drug importation to reduce pharmaceutical costs. However, these types of demands hurt that argument.
Jeffery Rosner, the senior director of pharmacy at Cleveland Clinic, said, “It would be difficult to regulate, there is not enough product in Canada to support the U.S., and importation doesn’t address the root cause of the pricing problem.” The FDA’s warning letter requires CanaRx to respond within 10 working days.
