Ross Joseph S, Dzara Kristina, Downing Nicholas S
Joseph S. Ross (
Kristina Dzara is a research associate in internal medicine at the Yale University School of Medicine.
Health Aff (Millwood). 2015 Apr;34(4):681-8. doi: 10.1377/hlthaff.2014.1160.
The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.
美国食品药品监督管理局（FDA）对新药的监管批准是一个漫长而复杂的过程，通常需要多个审查周期，这可能会延迟患者获得新的有效治疗方法。我们采用定性方法来描述2001年至2011年间FDA批准的新型治疗药物申请在批准前需要多个审查周期的安全性和有效性原因。在2001年至2011年间批准的需要多个审查周期的96份申请中，安全问题导致74份（77.1%）需要多个审查周期，有效性问题导致43份（44.8%）需要多个审查周期。我们的研究表明，多个审查周期似乎在使FDA保护公众健康以及在批准前确保充分了解临床益处和风险方面发挥着重要作用。
