FRIDAY, March 1, 2019 (HealthDay News) -- A large Canadian drug distributor sells unapproved and mislabeled medicines to Americans, the U.S. Food and Drug Administration warned Thursday. The distributor disputes the claim, however.
CanaRx sells common prescription medicines at a lower cost to hundreds of public and private employer programs in the United States, including city and county governments trying to save money, The New York Times reported. The company says it provides high-quality medications from Canada, Australia, and Britain, but the FDA says that is not always the case.
"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," FDA Commissioner Scott Gottlieb, M.D., told the Times. "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."
A statement on the FDA website urges consumers not to use any medicines obtained from CanaRx, but the agency does not offer any evidence that medicines sold by CanaRx come from countries other than those advertised, the Times reported. "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," Joseph Morris, general counsel for CanaRx, told the Times. Morris said that the company would cooperate with the FDA, but added that "many of the websites listed in the FDA letter belong to other entities completely unconnected to CanaRx." Of the websites listed in the letter, 123 were active CanaRx websites, 27 were CanaRx programs that have been terminated, and 15 were not affiliated with the company, Morris told the Times.
An FDA spokesman told the newspaper that the agency stood by its findings.