The FDA has again lashed out at a Canadian company that it has been feuding with for more than a decade for helping U.S. consumers get drugs on the cheap. Its clients, however, are shrugging off the warning that the products they have been buying for years might not meet U.S. standards.
The FDA last week slapped a warning letter on CanaRx for hooking U..S. consumers up with Canadian pharmacies to buy at discounted prices drugs that range from cancer drug Gleevec to HIV drug Truvada.
While the agency acknowledged that the Canadian “first-class drug regulatory process” assures high-quality drugs that come from the country’s pharmacies, it said there is no guarantee drugs that come through Canadian websites have been vetted by Canadian regulators.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit.,” the FDA said.
Consumers for years have crossed the border to buy drugs. In 2003 CanaRx was formed to provide mail-order service from Canada for public employee health plans in states that include Illinois, Vermont and Rhode Island and elsewhere.
An attorney for the company said the FDA has mischaracterized the CanaRx business model and operating protocols, and that it intends to continue to serve its U.S. clients.
One of those clients, Schenectady County, New York, defended the Canadian company that it has worked with for 15 years.
“This is a good program, and on the merits it looks lawful, and they are not doing the terrible things that the FDA is suggesting,” County Attorney Chris Gardner told Kaiser Health News.
He said about a quarter of the county’s 1,200 employees get their drugs from the Windsor, Ontario, company with no co-pays and that the program saved the county about $500,000 last year. He said the county will see how the situation plays out, but for now the program is being kept in place.
The FDA’s warning letter and announcement came after Florida Governor Ron DeSantis claimed he had President Trump’s backing to start a program to import drugs from Canada. Kaiser Health said that White House officials have chimed in since then that Florida would need approvals from state and federal officials to launch such a program.