探索21世纪治愈法案

The annual 美国法律与医学杂志 Symposium considered the implications—intended or otherwise—of the landmark legislation.

Health law scholars and practitioners from across the country gathered recently at 波士顿大学法学院 for the annual 美国法律与医学杂志（AJLM） Symposium. Participants considered the landmark 21世纪治愈法案, which passed into law in December 2016 with impressive bipartisan support.

由于公众对药品价格和获取的强烈抗议，以及业界要求减轻监管限制的压力，《治愈法案》旨在解决生物技术领域的障碍，推动药物和设备创新。 Speakers and attendees were welcomed by Andrea-Gale Okoro, AJLM editor-in-chief, and 弗兰米勒, professor emeritus who has taught a 食品和药物法研讨会 at BU Law since 2003.

“The Cures act is an unusual piece of legislation in terms of how universally it was accepted,” Professor Miller said. “It affected mostly the National Institutes of Health and the Food & Drug Administration (FDA), but the many moving parts involving such issues as the opioid crisis and mental health make the impact broader than anyone originally thought it would be. It’s a very important piece of legislation that has not yet been deeply explored.”

研讨会以南卡罗来纳大学法学院的杰奎琳·福克斯的演讲开始。 Fox focused on the time and resources wasted when patients are given care they don’t need. 她认为，《治愈法案》中旨在加速药物开发创新的机制可能会激励制药商在试验中操纵数据，从而导致系统中更多的浪费。 随后，安东尼•奥兰多和阿诺德•罗索夫澳门威尼斯人注册网站研究了消费者医疗保健设备和应用的增长市场：健身追踪器、智能手机应用、智能手表等。 罗索夫和奥兰多对隐私问题提出了警告，并表示，随着这些设备越来越受欢迎，保险公司越来越多地奖励使用它们的消费者，它们可能有一天会落入FDA的管辖范围。

休斯顿大学法律中心（University of Houston Law Center）的芭芭拉·埃文斯（Barbara Evans）继续讨论了《治愈法案》（Cures act）中内置的监管工具，她讨论了监管临床决策支持软件的挑战，在这种软件中，机器学习可以用来从大型数据集中筛选信息，并就谁应该得到哪种类型的护理提供建议。 Margaret Foster Riley, of the University of Virginia 法学院 and School of Medicine, explored how unclear standards for stem cell and gene therapies have given rise to unregulated stem cell clinics across the country, but found reason for optimism in some of the statute’s provisions. Finally, Michael Sinha, of Brigham & Women’s Hospital and Harvard Medical School, evaluated the success (or lack thereof) of the FDA’s priority review voucher program.

科文顿律师事务所高级法律顾问、哈佛大学法学院食品药品法教授彼得·巴顿·赫特发表了主旨演讲。 Hutt is known as the “godfather of FDA knowledge.” 作为FDA的前首席法律顾问，他撰写了大部分管理食品和药品法律的现代立法。 他的演讲涵盖了美国食品和药品监管的历史。 “No one has ever sat down and put together in one place the 200-year history of federal regulation of drugs in the US,” Hutt said, “so I decided it was time to do it.”

第一个下午的小组深入探讨了该法规所推动的开发真实世界证据（RWE）的挑战和监管考虑。 Sebastian Schneeweiss of Brigham & Women’s Hospital and Harvard Medical School explored progress in health care database analysis, as a supplement to clinical trials, in generating evidence on the effectiveness, harm, and value of medical products. Joan Krause and Richard Saver, of the University of North Carolina, then cautioned that claims about real-world effectiveness’s wide-ranging impact on the health care system are likely overstated, and warned that increased reliance on RWE could have significant implications for off-label fraud enforcement. 亚利桑那大学法学教授Chris Robertson讨论了基于实践的澳门威尼斯人注册网站研究网络如何通过改善临床护理和将澳门威尼斯人注册网站研究成果转化为实践来促进RWE在评估医疗产品方面的应用。

Next, Jordan Paradise of Loyola of Chicago Law School discussed the potential for a broader role for “citizen science” stakeholders within the Cures act. Noting that patient advocacy groups have been leading the charge regarding pharmaceutical products, she identified “iterative changes” that have enhanced the FDA’s ability to consult outside sources for information. 密苏里大学法学院的Sam Halabi澳门威尼斯人注册网站研究了基于证据的治疗和成本比较索赔的标准是如何在Cures法案下放松的，发现许多旨在保护患者和医生免受标签外营销行为的限制已不复存在。

在最后一个小组讨论中，宾夕法尼亚州立大学法律和医学客座教授詹妮弗·巴德指出，20世纪70年代的去机构化运动导致了美国监狱人口中精神疾病的高比例。 听起来很乐观，巴德强调了《治愈法案》中澳门威尼斯人注册防止精神病患者被监狱系统纠缠的项目的重新授权和资助。 东北大学法学院的利奥·贝勒茨基（Leo Beletsky）澳门威尼斯人注册网站研究了《治愈法案》解决阿片类药物危机的潜力。 他的实证分析表明，干预措施更多地集中在遏制药物过度处方上，而不是扩大获得美沙酮和其他已被证明更有效的治疗方法的途径。 最后，佐治亚州立大学的莱斯利·沃尔夫分析了保密证书和旨在促进涉及敏感数据的澳门威尼斯人注册网站研究并保护其免受强制披露的条款。

像AJLM研讨会这样的活动允许杰出的学者与波士顿大学法律界聚集在一起，参与最重要的关键问题。 在研讨会上发表的论文将在即将出版的一期《美国医学期刊》上发表。