FDA Posts Warning to Canadian Company Over Unapproved Drugs Sold to US Consumers
According to the agency, these drugs are potentially dangerous to consumers in the United States.
The FDA has posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs and misbranded drugs in the United States through online avenues. According to the agency, these drugs are potentially dangerous to consumers.1
“The FDA’s regulation and oversight of the drug approval process and distribution protects consumers by requiring rigorous scientific standards, labeling review for accuracy and completeness, and helping to ensure that counterfeit and unsafe drugs do not penetrate the US drug supply, among other things. When companies sidestep important drug safety measures and put patient health at risk by providing unapproved drugs that have been substituted for FDA-approved prescription drugs, it’s the agency’s responsibility to step in to protect the patients,” said FDA Commissioner Scott Gottlieb, MD, in a prepared statement.1
CanaRx is an international prescription service provider, according to its website. In a March 1 letter to consumers, responding to the FDA’s February 26 warning, G. Anthony Howard, CEO of the Ontario-based company, said CanaRx is not an internet pharmacy and that the FDA has not had an issue with the company for more than 15 years.2
“For over 20 years, the CanaRx team has been assisting patients in obtaining safe affordable medications from duly licensed and regulated brick-and-mortar pharmacies,” Howard wrote in the letter.2 “Individuals have saved all copayments while governments have reduced budget shortfalls and kept employees working.”
According to the FDA, the warning letter was posted as the result of a lengthy review of the company’s practices. The warning letter expresses the agency’s concerns with the methods CanaRx uses to contract with public and private entities to provide prescription drug coverage to their employees. For example, FDA officials said in the warning letter, CanaRx facilitates foreign physicians rewriting the employee’s US 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. According to the agency, this practice is 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.1
In addition, the FDA warns, drugs distributed by CanaRx may have different dosage strengths or be manufactured by companies different than the FDA-approved drug. They may be from different regions and they may be counterfeit. The substitution of FDA-approved prescription drugs with unapproved versions that may have substantially different risk profiles can pose serious health risks to consumers, especially in vulnerable patient populations that suffer from serious conditions, such as HIV, cancer or hepatitis.1
CanaRx’s substitution for prescribed FDA-approved drugs can have safety consequences for patients because, for example, their condition may not improve and the patient’s health care provider may not know that this may be attributed to an unapproved drug, the posted warning says. This can also cause potentially dangerous drug interactions with the patient’s other medications. In addition, sourcing drugs from uninspected, unregulated or unknown supply chains can result in serious health consequences, especially in vulnerable patient populations, who may receive drugs that are adulterated, or are not shipped or stored properly.1
The warning letter lists more than 150 websites affiliated with CanaRx and requests that the company respond within 10 working days, with details of how the violations noted in the warning letter will be corrected. Any violations in the warning that are not corrected could lead to enforcement action, the FDA said.1
Howard said, in his letter, that the FDA's posted warning contains inaccuracies regarding CanaRx. He said the company's legal team is preparing a more formal response to the agency.2
- FDA warns CanaRx for selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans [news release]. Silver Spring, MD; February 28, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632360.htm. Accessed March 2019.
- Howard GA. Re: fda warning letter observations [letter]. CanaRX website. http://www.canarx.com/wp-content/uploads/2015/02/FDA-Warning-Letter-Observations.pdf. Written March 1, 2019. Accessed March 2019.