一则争议正在美国法院内上演，与中国的制药巨头相挂钩。这家公司的故事就像是悬疑剧，涉及其在美国市场销售的药物成分在六年前是否就已经含有可能导致癌症的化学物质这一关键问题。
事件的核心是中国一家主要的制药企业在新泽西州面临一项审判。审理焦点在于该药企于2016年时对美国市场的药品销售中是否存在已被污染的、可能引发癌症的化学成分——这种情况发生在企业已知情且却未能及时告知的情况下。
在这一调查中，关键的电子邮件证据似乎已经遗失，并且该公司的首席执行官也离开了中国，以避免在美国法庭上接受质询。然而，在法庭争议持续的同时，该药企仍然被美国食品药品监督管理局（FDA）批准为更多患者生产药物。Prinston Pharmaceuticals，作为这家中国公司的一部分子公司，获准销售仿制药Vyvanse、Cialis，以及抗生素和另一款治疗多动症的药物。
回溯到2018年，当另一家药企发现Huahai生产的血压药物中混有致癌物质时，一系列召回事件随即发生。这场危机导致FDA检查了中国的生产设施，并决定禁止其向美国市场发送产品。然而，这一禁令在2021年后被撤销，当时该药企声称已经进行了整改。
监管中国制药企业的挑战仍然存在。自2021年起，美国的监督者未曾对Huahai进行完整的复核。在这个背景下，在美国法院中出现的一份决定表明：缺席证据和首席执行官未能出庭支持了指控——即该公司可能早在2018年公开揭露之前就已经了解到了这些污染情况。
尽管FDA允许其在美国市场生产更多药物，但对于是否愿意使用来自Huahai的产品，公众仍心存疑虑。此外，由于这家药企为其全球客户提供关键的制药原料，消费者可能无法得知其药品中到底含有哪家公司的成分。
值得一提的是，加利福尼亚州通过法律禁止了用于卫生棉条等女性用品中的“永远化学物质”。KFF健康新闻对北卡罗来纳州政府与当地医院之间缓解患者沉重医疗负担的斗争进行了调查。美国针对仿制药物市场的监管行动未能阻止问题转移至中国。华尔街日报报道，FDA在打击过度使用安非他命片剂的同时，发现这些活动已转移到中国。
当公众面临健康疑虑或有新闻线索值得深入挖掘时，请联系我们的团队进行反馈：[联系我们] 。
新闻来源：www.bloomberg.com
原文地址：Chinese Drugmaker on Trial in New Jersey Still Selling Drugs in US
新闻日期：2024-10-02
原文摘要：
Hi, it’s Anna in Virginia. A Chinese drugmaker has sparked a controversy in the US worthy of a courtroom drama. But first ...A major player in China’s drug industry is set to face a US jury next month in New Jersey. At issue is when the drugmaker, , knew pharmaceutical ingredients it was selling for the US market six years ago were contaminated with a chemical that likely causes cancer. Emails that may be able to help answer that question disappeared. And China’s Communist Party Huahai’s chief executive leave the country to answer lawyers’ questions in a deposition. In response to a plaintiffs’ request, Huahai’s counsel provided certification in October 2022 that the company didn’t have any more documents, according to the company’s objections to the judge’s ruling. Lawyers for Huahai also said the emails do not exist because a key hard drive had been damaged.Yet while the courtroom drama has played out, Huahai has been approved to make more drugs for American patients. The US Food and Drug Administration has cleared Prinston Pharmaceuticals, one of Huahai’s , to sell generic copies of the Vyvanse and the Cialis as well as an antibiotic and another ADHD drug, among others. When another pharmaceutical company discovered a carcinogen in a blood pressure drug Huahai made in 2018, it set off a cascade of recalls. (You can read more about that .) The FDA sent inspectors to the plant in China and found to ban the factory from sending products to the US. The FDA reversed the ban in 2021 after it said Huahai had cleaned up its act. Still, it can be difficult to keep an eye on pharmaceutical companies in China. US inspectors haven’t been back to Huahai for a full accounting since 2021, according to an . Back in the US, the retired judge helping oversee preliminary hearings, Thomas Vanaskie, wrote in July that the missing evidence and elusive CEO support that Huahai “likely knew of the contamination before its ultimate disclosure in 2018,” according to his 22-page .The ruling lays out how a jury will hear about these omissions and be told they can decide whether Huahai was involved in a cover-up.Huahai and Prinston didn’t respond to a request for comment. Even though the FDA allowed the company to make more drugs for the US market, I’m not sure I’d want to take them given, what the court has revealed. But since Huahai makes key drug ingredients and sells them to companies besides Prinston, we don’t always get to know whether Huahai is in our medicine cabinets or not. — California banned forever chemicals in tampons and other menstrual products, the Los Angeles Times . KFF Health News investigated the battle between North Carolina’s state government and its hospitals to relieve patients’ crushing .The US targeted an Adderall pill mill but it moved to China, the Wall Street Journal .Health questions? Have a tip that we should investigate? Contact us at .
