With perhaps an eye on efforts to allow for the import of less expensive medicines from Canada and elsewhere, the US Food and Drug Administration (FDA) this week sent a warning letter to a company that was providing drugs not approved by FDA to Americans.
Specifically, the company receiving the warning letter, CanaRx, acts as a broker between foreign pharmacies and employer-sponsored health insurers to provide enrolled employees with prescription drugs.
How the system works, according to FDA: CanaRx accepts an employee’s US prescription and facilitates its reissue under the direction of a foreign physician. The reissued prescription is then filled by a pharmacy contracted by CanaRx in that foreign physician’s jurisdiction. The foreign pharmacy then ships the drug directly to the employee in the US.
The warning letter notes how for each shipment, CanaRx uses the same templated invoice, with the standard disclaimer, “[d]epending on your country, our medications may appear to be different in size, shape or color.”
“Having this disclaimer in each invoice demonstrates that CanaRx has designed its business to operate in a manner that substitutes the FDA-approved drugs prescribed by the U.S. healthcare provider with unapproved drugs,” FDA said. “This distribution scheme is particularly concerning, 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 letter notes how the FDA-approved versions of several drugs listed on CanaRx’s medication lists have been subject to recalls in the US.
“FDA has established processes to recall unsafe, substandard, and poor-quality drugs within the legitimate U.S. drug supply chain. No such safeguards exist for unapproved drugs illegally distributed in the U.S. from foreign sources such as those provided through CanaRx,” the letter notes.
In addition, several of the unapproved versions of FDA-approved drugs offered by CanaRx have different trade names or dosage amounts in their labeling when compared to FDA-approved products, which “can cause patient confusion and lead to medication errors.”
Examples of drugs offered on CanaRx’s medication and a list of all the websites that the company operates are included in the warning letter.
In response to the warning letter, Joseph Morris, counsel for CanaRx, told Focus
: “We do not disagree with the FDA's goals of fighting counterfeits and dangerous drugs and of guiding people to regulated and licensed brick-and-mortar pharmacies. That's exactly what CanaRx does.”
He also took issue with other aspects of the warning letter, explaining that CanaRx is not an internet pharmacy.
“FDA's characterizations of the CanaRx business model and operating protocols are completely wrong,” Morris said. “Some of the websites listed by the FDA have no connection with CanaRx, and some of the business addresses are also completely unconnected with CanaRx.”
But confirming some of what was included in the warning letter, he added: "What an American patient obtains through a CanaRx program is an approved version of an FDA-approved brand-name medicine -- no generics and no substitutions -- dispensed by a brick-and-mortar pharmacy directly to the patient in the brand-name manufacturer's packaging. It must conform to the doctor's prescription as to dose, etc.," he added. CanaRx said in a statement that the pharmacies are located in Canada, the UK or Australia.
The company has 10 days to respond to FDA. CanRx said it will respond formally to FDA's warning letter next week.