The 21st Century Cures Act (“Cures Act”) relies on the concept of real-world evidence (“RWE”) to improve the Food and Drug Administration (“FDA”) approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated.The real world of RWE is messy and uncertain. Successfully incorporating RWE into regular health care system decision-making, beyond the FDA, faces considerable obstacles and limitations. We review the reasons to be wary about RWE as a game-changer. These concerns including data reliability, insufficient incentives for stakeholders to generate and engage with high-quality RWE, and lack of comprehensive regulatory oversight. In addition, the push for RWE may impact the enforcement of the health care fraud and abuse laws, perhaps not in necessarily positive ways. Increased reliance on RWE may have significant implications for off-label fraud enforcement, further conflating the distinction between claims that are false for reimbursement rather than for scientific purposes.

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真实世界中的真实世界证据：超越 FDA

21英石世纪治愈法案（“治愈法案”）依靠真实世界证据（“RWE”）的概念来改进食品和药物管理局（“FDA”）的批准程序。这在 FDA 监管之外更广泛地应用 RWE 增加了兴趣并推动了动力。在本文中，我们讨论了 RWE 实用应用的可理解吸引力及其许多潜在好处。但我们也警告说，关于 RWE 对医疗保健系统的广泛、改善影响的说法可能被夸大了。RWE 的真实世界是混乱和不确定的。成功地将 RWE 纳入 FDA 之外的常规医疗保健系统决策，面临着相当大的障碍和限制。我们回顾了对 RWE 作为游戏规则改变者保持警惕的原因。这些问题包括数据可靠性、对利益相关者产生和参与高质量 RWE 的激励不足，以及缺乏全面的监管监督。此外，对 RWE 的推动可能会影响医疗欺诈和滥用法律的执行，也许不一定是积极的方式。增加对 RWE 的依赖可能会对标签外欺诈执法产生重大影响，进一步混淆了对报销而非科学目的的虚假声明之间的区别。