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美国食品药品监督管理局的人事流动达到极端水准,今年年初以来除了一位之外所有中心主任都被撤换或离职,过去一年约有九成高阶主管离开。由局长玛蒂·马卡里领导的这个机构,监管约占全美消费支出五分之一的市场,每年审视超过3.9兆美元的产品。尽管编制缩减到约一万六千名员工、预算约七十亿美元,频繁的人事震荡已让整个FDA几乎面目全非。

马卡里透过右翼播客拉拢川普的基本盘,宣传被推翻的说法,如爱滋病与莱姆病是在实验室被制造,并夸口他的新生儿将跳过医师建议的B型肝炎疫苗。他也容忍副手维奈·普拉萨德发表类似言论,后者散布缺乏证据的指控,称新冠疫苗导致儿童死亡,促使十二位FDA前领导人在《新英格兰医学杂志》撰文谴责这种监管路线。批评者称药品审查已被政治化,并为配合川普降价要求的公司开辟快速通道。

政治与监管动荡正外溢到市场与企业并购。具影响力的审查官里克·帕兹杜尔请辞后,生技股下跌,进一步加剧今年一月以来已历经五任主管的关键药品审批部门的不稳定。同时,派拉蒙斯凯丹斯对华纳兄弟探索发动的恶意收购,比Netflix的竞争方案多提供股东一百八十亿美元现金,而川普警告Netflix与华纳兄弟结盟后的合并市占率可能对反垄断监管构成问题。

Turnover at the Food and Drug Administration has reached extreme levels, with all but one center director removed since the start of the year and about 90% of last year’s senior leaders gone. The agency, led by Commissioner Marty Makary, regulates roughly one fifth of US consumer spending and oversees more than $3.9 trillion in products. Despite a shrinking workforce of about 16,000 and a budget near $7 billion, its leadership churn has made the FDA nearly unrecognizable.

Makary has courted Donald Trump’s base through right‑wing podcasts, promoting debunked claims that HIV and Lyme disease were engineered in labs and boasting that his newborn would skip the hepatitis B vaccine. He has tolerated similar rhetoric from his deputy Vinay Prasad, who floated unsupported allegations that Covid vaccines killed children, prompting a group of 12 former FDA leaders to condemn the approach in the New England Journal of Medicine. Critics say drug reviews are being politicized and fast‑tracked for companies that align with Trump’s pricing demands.

Political and regulatory turmoil is spilling into markets and corporate dealmaking. Biotech stocks fell after influential regulator Rick Pazdur resigned, adding to instability in a key drug approval division that has seen five directors since January. Meanwhile, a hostile takeover bid for Warner Bros. Discovery by Paramount Skydance offers shareholders $18 billion more in cash than Netflix’s rival proposal, even as Trump warns that the combined market share in a Netflix–Warner Bros. tie‑up could be a problem for antitrust regulators.

2025-12-09 (Tuesday) · 8d41a8cba64281fe31449abd7b453bad99882edd