FDA warns that not all CanaRx’s prescription drugs it is importing into the U.S. are safe for use.
CanaRx, a Canada drug company, sells many prescription medicines at a lower cost to public and private employer programs in the United States, and many of these buyers are city and county governments seeking to save money. CanaRx says the medications it sells are high-quality, but the Food and Drug Administration (FDA) has found that this isn’t always true. In fact, the ingredients that are presumed to be in some of the products may not be at all.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that some of those drugs are from other countries with lax standards,” Dr. Scott Gottlieb, the FDA commissioner, said. “Such operations 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.”
Joseph Morris, general counsel for CanaRx, responded, “Every prescription that is dispensed through a CanaRx program is dispensed directly to the patient from a licensed, regulated, brick-and-mortar pharmacy in Canada, Britain, or Australia, and the patient can be sure that medicine she receives is the medicine that her doctor ordered.”
Vermont Senator Bernie Sanders (Independent) and House Democrats Elijah Cummings and Ro Khanna, have suggested legislation that would allow pharmacies, wholesalers, and patients to import medicine from Canada and other countries. The prices of these drugs would be based on the median price of U.S.’s and all of the countries from which it imports. This, they believe, would make the cost of the drugs fair and reasonable. Governor Ron DeSantis in Florida recently proposed importing Canadian drugs to his state to save money.
Dr. Gottlieb said he was certain that prescriptions sold by Canadian pharmacies were safe, but not all online websites claiming to have bought their drugs in Canada. He said specifically he was unsure of the safety of CanaRx’s sale of drugs with special protections because they were high-risk and needed to be carefully managed to protect patients.
“CanaRx is causing important safety measures that are put in place for the FDA-approved versions of these drugs to be bypassed,” the warning letter he issued said.
Mr. Morris, CanaRx’s attorney, said he thought the agency might have confused some websites that advertised or sold imported drugs with CanaRx. “Many of the websites listed in the FDA letter belong to other entities completely unconnected to CanaRx,” he said. Morris wrote back that 27 were CanaRx programs that were terminated, and 15 were not affiliated with the company.
“The cost savings are often very great, which benefits the individual consumer and their plan sponsors,” Mr. Morris added.
The FDA’s letter requested that CanaRx immediately stop selling unapproved new drugs from foreign sources to American buyers. It stated some of the drugs received through the program treat hepatitis, cancer or HIV. The letter indicates those are “serious medical conditions and that side effects of drugs that may have been recalled, but still obtained through CanaRx, could be life-threatening.”
“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. health care provider with unapproved drugs,” the FDA wrote.