The U.S. Food and Drug Administration sent a warning letter Thursday to CanaRx, a pharmaceutical middleman that is endangering consumers by allegedly selling unapproved, misbranded and unsafe drugs.
CanaRx acts as a broker between foreign pharmacies and employer-sponsored health insurance plans. As of 2017, the intermediary contracted with more than 150 public and private employers in about 35 states, the FDA said.
CanaRx accepts the employee's U.S. prescription and a foreign doctor rewrites the prescription filled with drugs from an unknown source. The drugs, purportedly sourced from Canada, the United Kingdom or Australia, are then shipped directly to the employee with the standard disclaimer—"Depending on your country, our medications may appear to be different in size, shape or color."
The company's medications, which include a range of drugs treating HIV, cancer, hepatitis, organ rejection, cancer, epilepsy, asthma and pulmonary arterial hypertension, may have been subject to recalls or could be sub-potent, super-potent or mixed with unknown ingredients, the FDA 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," FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.
Consumers are inclined to trust drugs sourced through their employer's health plan. To make matters worse, consumers have no means of recourse if they are harmed by a drug, the FDA said. One drug currently offered by CanaRx is Tegretol. Small differences in dose or blood concentration for these narrow-therapeutic index drugs can be fatal.
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, said Erin Fox, the senior director of drug information and support services at University of Utah Health.
"This could be a big safety risk for some patients who are getting drugs that may be different than what the doctor actually prescribed," she said. "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 lists more than 150 websites affiliated with CanaRx, although there are likely more.
Some policymakers are pushing to allow drug importation to lower pharmaceutical costs. But these types of schemes hurt that argument.
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, said Jeffrey Rosner, senior director of pharmacy contracting and purchasing at Cleveland Clinic.
The warning letter requires CanaRx to respond within 10 business days.