Arnold & Co.

美国总统特朗普于1月31日签署行政命令，要求联邦机构每发布一项新法规，必须同步废除十项旧法规。这一被称为“十换一”的政策将对美国 FDA 等卫生监管机构形成巨大压力。专家指出，此举可能迫使 FDA 重新评估现有法规的存废，但也可能抑制新规出台，加剧行业不确定性。 该行政令延续了特朗普首个任期内“二换一”的法规精简思路，但力度显著加大。特朗普在声明中称，联邦法规的过度膨胀“推高合规成本，阻碍创新与国家竞争力”，并强调新政策旨在“降低企业负担，保障美国经济繁荣与公民生活质量”。 行政令对“法规”的定义极为宽泛，涵盖正式法规、备忘录、指南文件、机构间协议及政策声明等。霍金路伟律师事务所合伙人 Cybil Roehrenbeck 指出，这种宽泛定义可能导致执行中的不确定性。“特朗普政府需明确如何界定和计算‘十项旧规’，尤其是涉及 FDA 复杂的技术指南文件时。” 多位专家认为，行政令可能成为清理冗余法规的契机。Roehrenbeck表示，“许多行业利益相关者已开始罗列希望废除的低效法规，尤其是那些阻碍创新的条款。”但她同时警告，长期的政策不确定性可能影响企业投资决策。 Arnold & Porter 律所合伙人 Mahnu Davar 指出，2017 年“二换一”政策曾推动 FDA 清理部分闲置法规，但整体影响有限。相比之下，“十换一”的要求更为激进，可能显著影响 FDA 未来指南文件的制定节奏。“关键问题在于，FDA 如何平衡国会授权的法规与新政策的要求。” 根据行政令，任何新规的净成本需为零或低于废除旧规的节省成本。Roehrenbeck 分析称，这要求 FDA 在制定新规时进行更严格的成本效益分析，但现行成本核算通常仅覆盖法规实施成本，而非企业合规成本，未来核算方式可能面临调整。 此外，FDA 需密切关注卫生与公众服务部（HHS）即将发布的统一法规制定议程，该文件将揭示特朗普政府的法规优先级。Roehrenbeck 预测，“新议程可能大幅缩水，与拜登政府 2024 年秋季版本形成鲜明对比。” Arnold & Porter 律所另一合伙人 Philip Desjardins 指出，医疗器械 De Novo 分类流程可能成为观察重点。FDA 通过分类令确定新器械的监管路径，但此类命令是否被纳入“法规”范畴尚不明确，其审批效率或受影响。 尽管特朗普政府强调精简法规的必要性，但 Roehrenbeck 提醒，政策需与管理与预算办公室（OMB）的监管框架协调，且 HHS 新任官员到位前，部分法规调整可能暂缓。“当前阶段，FDA 需在清理旧规与维持必要监管之间找到平衡，避免关键公共卫生领域出现漏洞。” 封面图来源：123rf 暴增超2000%！两款单抗，撑起阿尔茨海默病一片天 2025-02-10 罗氏CD20单抗三期临床结果积极，闯入蓝海自免市场！ 2025-02-08 核药：首个十亿美元分子诞生！ 2025-02-07 版权声明/免责声明 本文为授权转载文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击，查看更多精彩!

A revived legal challenge to the abortion pill mifepristone will be an early test for President Donald Trump’s administration and his appetite for further weighing in on reproductive health access in the US. Three states were allowed to proceed with a lawsuit against the HHS and the FDA last week, resurrecting a case that the US Supreme Court unanimously rejected last year. Those states — Kansas, Idaho and Missouri — argue in part that FDA’s rules allowing for nationwide mailing of the pill, known as Mifeprex, fly in the face of state-level restrictions on abortion care. The case gives the new administration a chance to chart its own path on mifepristone access, which was one of the few levers at former President Joe Biden’s disposal after Roe v. Wade was overturned. The Supreme Court unanimously rejected a similar complaint brought by the Alliance for Hippocratic Medicine, an anti-abortion organization, for lack of standing. On Saturday, the FDA moved to dismiss the latest complaint , arguing that the states lack adequate venue to make their case. Eva Temkin, a partner at Arnold & Porter who helped represent industry stakeholders filing an amicus brief in the first case, couldn’t get past the states’ decision to file the case in the Northern District of Texas. “It seems difficult to understand how these states have a basis to sue in Texas,” she said in an interview. “It seems like these states, if they have a claim to raise, should do it in a forum with which they would have venue.” But now it’s up to Trump and his DOJ to defend the case, with former Florida Attorney General Pam Bondi on track to lead the department. At her confirmation hearing last week , Bondi sidestepped a request by Sen. Cory Booker (D-NJ) to commit to defending the FDA against lawsuits involving mifepristone and the agency’s regulatory authority. Bondi said that while she was “personally pro-life,” she would “not let my personal beliefs affect how I carry out the law.” Amanda Zablocki, a partner at Sheppard Mullin, said Bondi’s answer was not a clear position. “That remains an open question in my mind,” Zablocki told Endpoints News. “It was vague enough that it gives her a lot of flexibility to come in and decide whether or not she’s going to staunchly defend.” The FDA declined to comment on ongoing litigation. The Trump transition team did not respond to a request for comment prior to the inauguration, and the White House could not be reached on Tuesday. One of the core features of the amended lawsuit is framing the FDA’s removal of in-person dispensing rules as a matter of states’ rights. The FDA removed the in-person requirement in 2021 and made the rule permanent in 2023. Laws in Kansas, Missouri and Idaho vary in their restrictiveness against mifepristone prescriptions. “The FDA actions created a 50-state abortion drug mailing economy, undermining state abortion laws,” the plaintiffs wrote in their amended complaint. All three of Trump’s nominations to the Supreme Court in his first term voted in favor of overturning Roe v. Wade , which became a rallying cry for Democrats in political races across the country. It’s unlikely to just be Republican attorneys general who challenge the FDA, Zablocki said. States in favor of preserving or expanding abortion access could also sue, as 12 did in 2023, arguing that mifepristone rules should be further relaxed to increase access. “The question in my mind is, is the FDA going to look at these cases more holistically and develop a broader strategy, rather than kind of a whack-a-mole attempt at addressing each of these cases as they spring alive,” Zablocki said. The previous mifepristone case drew condemnation from hundreds of biotech executives and investors, who signed on to an open letter condemning a 2023 decision from Judge Matthew Kacsmaryk of the Northern District of Texas, which overturned the approval of mifepristone. Both BIO and PhRMA subsequently cheered the case’s dismissal by the Supreme Court last year, saying it was a win for regulatory consistency that drug developers rely on. Neither group immediately responded to a request for comment on the new lawsuit.

None Since the introduction of the BIOSECURE Act in January, named companies and U.S.-based biopharmas alike have speculated on what the legislation could mean for the life sciences industry. In this week's episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner sits down with Arnold & Porter’s Life Sciences practice chair Dan Kracov to discuss the broader implications of the bill, and what the likely next steps are for the legislation to become law. Kracov also breaks down what measures life sciences companies are already taking in light of the bill and concessions that may need to be made to appease lawmakers on both sides of the aisle.  To learn more about the topics in this episode: After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concernedDespite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projectsLawmakers urge FDA to investigate clinical trials run in tandem with China's military