WeChat ID GMPOFFICE Intro 国内外(FDA、EMA、MHRA、CFDA、WHO、PIC/S等)GMP法规解读;制药行业监管动态;各类实施指南(ISPE、PDA、ISO、ASTM等)分享 摘译如下: Ohio Attorney General Mike DeWine filed a lawsuit on May 31, 2017 against five prescription opioid manufacturers, claiming the companies misled prescribers to believe that opioids were non-addictive. Names five opioid manufacturers, including Purdue Pharma, Endo Health Solutions, Teva Pharmaceutical Industries, and its subsidiary Cephalon, Johnson & Johnson, and its subsidiary Janssen Pharmaceuticals, and Allergan. 美国俄亥俄州总检察长于2017年5月31提起了一份对5家阿片类处方药生产商的诉讼,控诉这些公司误导消费者相信这些阿片类药品不会成瘾。这5家阿片类药品生产商分别是Purdue制药、远藤健康、梯瓦制药工业及其子公司Cephalon、强生及其子公司杨森制药、Allergan。 The lawsuit alleges that the companies violated the Ohio Consumer Sales Practices Act and created a public nuisance by propagating misleading statements about opioids. These misleading statements include advertisements, statements made my sales representatives, and the use of front groups that delivered information inflating the benefits and downplaying the risks of opioids. 该诉讼声称这些公司违反了俄亥俄河消费者销售规范法,并因传播关于阿片类药品的误导性言论产生了公共妨害。这些误导性言论包括广告、销售代表的言论、使用合法组织从事传播鼓吹疗效和淡化阿片类药品风险的信息。 "We believe the evidence will also show that these companies got thousands and thousands of Ohioans—our friends, our family members, our co-workers, our kids—addicted to opioid pain medications, which has all too often led to use of the cheaper alternatives of heroin and synthetic opioids. These drug manufacturers led prescribers to believe that opioids were not addictive, that addiction was an easy thing to overcome, or that addiction could actually be treated by taking even more opioids," DeWine said in astatement. "They knew they were wrong, but they did it anyway—and they continue to do it. " DeWine 在声明中说:“我们相信该证据还会显示这些公司使千千万万俄亥俄州人民——我们的朋友,我们的家人,我们的工作伙伴,我们的孩子——对阿片类止痛药物上瘾,这经常导致使用更为便宜的海洛因和人造阿片作为替代品。这些药物生产商使得开药人员相信:阿片类药品不会成瘾、成瘾是很容易克服的事情,或者成瘾了可以多吸点阿片。” “他们明明知道这是错误的,但是他们还是这么做了。” 公众号 GMP办公室 专业的GMP合规性研究组织 国内外(FDA、EMA、MHRA、CFDA、WHO、PIC/S等)GMP法规解读; 国内外制药行业GMP监管动态; GMP技术指南(ISPE、PDA、ISO、ASTM等)分享 Reward people gave a reward 长按二维码向我转账 受苹果公司新规定影响,微信 iOS 版的赞赏功能被关闭,可通过二维码转账支持公众号。 Scan QR Code via WeChat to follow Official Account