Ensuring the safe and effective FDA regulation of fecal microbiota transplantation.
Ensuring the safe and effective FDA regulation of fecal microbiota transplantation.
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DOI：
10.1093/jlb/lsv032
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发表时间：
2015-07
影响因子：
3.4
通讯作者：
Edelstein CA
中科院分区：
文献类型：
--
作者：
Sachs RE;Edelstein CA
科学家、政策制定者和医疗专业人士越来越担心抗生素耐药性的上升，以及艰难梭菌等细菌引起的感染数量不断增加，这些细菌导致大量死亡，并给我们的医疗保健系统带来了越来越大的成本。然而，在过去几年中，粪便微生物群移植（FMT），即将健康供体的粪便移植到患者肠道中，已成为治疗复发性艰难梭菌感染的一种非常有效的方法。目前，FDA正在提议将FMT作为生物药物进行监管。然而，这种提议的分类既监管不足又监管过度。 FDA 的主要目标是确保患者能够获得安全、有效的治疗，因此他们应该比他们提议的更严格地监管 FMT 的某些方面，而在其他方面则应不那么严格。本文将探讨 FDA 在决定将 FMT 作为生物药物进行监管时将面临的监管挑战的性质，然后评估 FDA 可以采取的政策替代方案，最终得出结论，FDA 应该考虑采用混合监管模式，就像在脐带血案例中所做的那样。
Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance, and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and are imposing increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both underregulatory and overregulatory. The FDA's primary goal is to ensure that patients have access to safe, effective treatments—and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood.
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影响因子：
158.5
作者：
GLUCKMAN, E;BROXMEYER, HE;BOYSE, EA
通讯作者：
BOYSE, EA
DOI：
10.1056/nejmra0707500
发表时间：
2008-10-30
期刊：
The New England journal of medicine
影响因子：
--
作者：
Kelly, Ciaran P;LaMont, J Thomas
通讯作者：
LaMont, J Thomas
DOI：
10.1056/nejmoa1306801
发表时间：
2014-03-27
期刊：
The New England journal of medicine
影响因子：
--
作者：
Magill SS;Edwards JR;Bamberg W;Beldavs ZG;Dumyati G;Kainer MA;Lynfield R;Maloney M;McAllister-Hollod L;Nadle J;Ray SM;Thompson DL;Wilson LE;Fridkin SK;Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team
通讯作者：
Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team
影响因子：
1.7
作者：
Kassam, Zain;Lee, Christine H.;Hunt, Richard H.
通讯作者：
Hunt, Richard H.
影响因子：
12.3
作者：
Caporaso JG;Lauber CL;Costello EK;Berg-Lyons D;Gonzalez A;Stombaugh J;Knights D;Gajer P;Ravel J;Fierer N;Gordon JI;Knight R
通讯作者：
Knight R