Grassley launches probe into Novartis' Zolgensma mess

格拉斯利对诺华(Novartis)公司的 Zolgensma 丑闻展开调查

2019-08-13 12:47:57 pharma

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Novartis caught plenty of flack with last week’s revelation that its FDA application for gene therapy Zolgensma contained manipulated data and that the company didn't inform regulators until after its approval. Now it's facing a congressional investigation.   In a letter to Novartis CEO Vas Narasimhan, Senate Finance Committee chair Chuck Grassley said the company's conduct was “reprehensible and could have an adverse effect on patients.” The influential senator struck up an investigation, asking the drugmaker to send in its records for the incident. Grassley wants to drill into the timeline of events, from when the company learned about the problem to its internal investigation and on to its disclosing the problem to the FDA. And he wants info on Novartis' response—from the number of employees who have been or will be fired to the company's plan for preventing similar problems in the future. A Novartis spokesman said the company received the letter and is reviewing Grassley's requests. RELATED: FDA ready to crack down as Novartis reveals manipulated Zolgensma data  The FDA last week disclosed that Novartis' Zolgensma application contained manipulated data and that the drugmaker didn't inform regulators about the irregularities until after the med's approval. The agency approved the drug in May to treat certain spinal muscular atrophy patients under two years old.  A scandal erupted, and Narasimhan hosted a conference call with analysts the following day to detail the company’s side of the story. Novartis execs said a scientist with the company’s gene therapy outfit AveXis notified the drugmaker of data manipulation in mid-March. Then, the company started and finished an internal probe before bringing the issue to the FDA. According to the FDA, Novartis notified the agency of the data manipulation in late June.  RELATED: Novartis CEO: 'We did the best we could' in Zolgensma data manipulation probe  Meanwhile, the agency had approved Zolgensma in late May without knowledge of Novartis’ probe. Last week, the regulator went public, and acting FDA chief Ned Sharpless said the agency is considering criminal or civil punishments.  The drugmaker and regulators determined Zolgensma is safe and effective and should remain on the market. Democratic lawmakers piled on days later, writing Sharpless to urge him to use his “full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil, and regulatory actions against the company.”  RELATED: Sanders, Warren join team of senators blasting Novartis' Zolgensma data rig  “Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior,” they added.  The Zolgensma data manipulation revelations are the latest regulatory misstep for Novartis amid a series of scandals in recent years. Back in 2013 and 2014, authorities in Japan discovered the company manipulated trial data and failed to report side effects. The company has also faced bribery allegations around the world and an embarrassing episode with President Donald Trump's former personal attorney Michael Cohen last year.   Narasimhan has said he's making compliance a priority, but the Zolgensma issue shows the company still has some work to do. 
诺华( Novartis )上周披露,其向 FDA 申请基因治疗佐尔甘斯曼( Zolgensma )的申请含有操纵数据,在获得批准之前,该公司没有通知监管机构。现在它正面临国会的调查。 参议院财务委员会( Senate Finance Committee )主席查克•格拉斯利( Chuck Grassley )在写给诺华(Novartis)首席执行官瓦丝•纳拉西姆( Vas Narasimhan )的信中表示,该公司的行为“应受到谴责,可能对患者产生不利影响”。这位颇具影响力的参议员发起了一项调查,要求制药商将事件记录在案。 格拉斯利希望深入了解事件的时间安排,从公司了解到问题到内部调查,再到向 FDA 披露问题。他希望了解诺华(Novartis)的反应——从已经或将要被解雇的员工数量,到该公司未来预防类似问题的计划。 诺华(Novartis)的一位发言人说,该公司收到了这封信,并正在审查格拉斯利的请求。 相关信息:随着诺华(Novartis)公司披露了 Zolgensma 操纵数据, FDA 准备对此进行打击 FDA 上周披露,诺华(Novartis)的 Zolgensma 应用程序包含了被操纵的数据,在获得了美国医药管理局的批准之前,这家制药商没有告知监管机构这些违规行为。该机构在5月份批准了该药物,用于治疗某些两岁以下的脊髓性肌萎缩症患者。 一场丑闻爆发,第二天, Narasimhan 与分析师召开了一次电话会议,详细描述了该公司的情况。诺华(Novartis)高管表示,该公司基因治疗机构 AveXis 的一位科学家在3月中旬向制药商通报了数据操纵的情况。然后,该公司开始并完成了内部调查,然后把问题提交给 FDA 。据 FDA 称,诺华(Novartis)公司在6月下旬向 FDA 通报了数据操纵情况。 相关报道:诺华(Novartis)公司首席执行官:在佐尔甘马数据操纵调查中,我们尽了最大努力 与此同时,该机构在5月下旬批准了佐尔甘斯曼( Zolgensma ),但对诺华(Novartis)的调查一无所知。上周, FDA 上市,代理首席执行官 NedSharpless 说, FDA 正在考虑刑事或民事处罚。 制药商和监管机构认定 Zolgensma 是安全有效的,应该继续留在市场上。 几天后,民主党议员们蜂拥而至,写信给夏普勒斯,敦促他利用自己的“全权,追究乐视的渎职责任,包括采取一切适当的刑事、民事和监管行动,打击乐视。”这是一个很好的例子 相关报道:桑德斯,沃伦加入参议员团队,抨击诺华(Novartis)的 Zolgensma 数据平台 他们补充说:“任何没有强有力反应的事情,都将为未来的制药不当行为发出绿灯。” 佐尔格森玛数据操纵披露是诺华(Novartis)近年来一系列丑闻中的最新监管失误。早在2013年和2014年,日本当局就发现该公司操纵了试验数据,未能报告副作用。该公司还面临着世界各地的贿赂指控,以及去年总统唐纳德·特朗普的前私人律师迈克尔·科恩( Michael Cohen )遭遇的尴尬事件。 Narasimhan 说他把合规作为首要任务,但 Zolgensma 的问题表明公司仍有一些工作要做。

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