FDA slams Canadian firm shipping cheap drugs to U.S.

FDA 谴责加拿大药商 CanaRx 向美国人出售低价药品

2019-03-08 18:40:00 pharma


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.
美国食品和药物管理局再次抨击一家加拿大公司,FDA十多年来一直与这家加拿大公司争执,因为这家公司帮助美国消费者低价购买药品。然而,该公司的客户却对多年来一直购买的产品可能不符合美国标准的警告不屑一顾。 美国食品和药物管理局( FDA )上周对 CanaRx 发出了一封警告信。。S 。消费者通过加拿大药店以折扣价购买从癌症药物 Gleevec 到 HIV 药物 Truvada 的药物。 尽管该机构承认,加拿大“一流的药品监管程序”确保了来自该国药店的高质量药品,但它表示,加拿大监管机构并不保证通过加拿大网站获得的药品得到审查。 “像 CanaRx 这样的公司使用他们的名字来暗示病人正在接受加拿大批准的药物,当病人很可能正在接受其他国家的药物时,这些药物可能是亚力、超强或假冒的。FDA 说。 多年来,消费者已经跨越边境购买药品。2003年, CanaRx 成立,为伊利诺伊州、佛蒙特州和罗德岛等州的公共雇员健康计划提供加拿大的邮购服务。 该公司的一名律师说, FDA 对 CanaRx 的商业模式和运营协议进行了错误的定性,并打算继续为其美国客户服务。 其中一位客户,纽约的 Schenectady 郡为这家加拿大公司辩护说,该公司已经合作了15年。 “这是一个很好的计划,根据它看起来合法的优点,他们没有做 FDA 建议的可怕的事情,”县检察官克里斯·加德纳告诉凯泽健康新闻。 他说,在该州1200名员工中,约有四分之一的人从安大略省的温莎( Windsor )公司购买药物,但没有共同支付费用,该项目去年为该州节省了约50万美元。他说,县政府将看到局势如何发展,但目前该计划仍在进行中。 FDA 的警告信和声明发布之前,弗洛里达州州长罗恩·德桑蒂斯声称,特朗普总统支持启动从加拿大进口药品的计划。Kaiser Health 说,白宫官员从那时起就开始介入,弗洛里达州将需要州政府和联邦政府官员的批准才能启动这样的项目。