FDA warns Canadian drug distributor about sending ‘unsafe’ drugs to U.S.

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FDA warns Canadian drug distributor about sending ‘unsafe’ drugs to U.S.
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A CanaRx representative said he was baffled by the action, saying it facilitates sales of “American brand-name drugs only.”

By Lenny Bernstein and Lenny Bernstein Reporter covering health and medicine Email Bio Follow Laurie McGinley Laurie McGinley Reporter covering health and medicine Email Bio Follow February 28 at 4:20 PM The Food and Drug Administration issued an unusual warning letter Thursday to a Canadian drug distributor, contending the company has sent “unapproved” and “misbranded” drugs to consumers in the United States, jeopardizing their safety.

FDA Commissioner Scott Gottlieb said in an interview that the move “isn’t timed with anything. This isn’t politically motivated. This is our bread and butter. This is public health protection 101.” Morris, however, said the company facilitates only the sale of medicine made by brand-name companies such as Pfizer and Merck licensed by the FDA — in the original packaging. He said individual consumers submit prescriptions from U.S. doctors. Those are rewritten by doctors in Canada, Britain and Australia and filled by bricks-and-mortar pharmacies in those countries, he said. The drugs are then mailed to consumers, who pay, on average, 30 percent of the price they pay here.

The FDA said it has no reports of adverse reactions to drugs supplied by CanaRx. Rather, Gottlieb said in the interview, the FDA has tried to persuade CanaRx to reform practices that it contends allow counterfeit, adulterated, weak, super-potent and mislabeled drugs into the United States.

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