穿越审批的海峡：美国食品药品监督管理局（FDA）审批的本质及其对外科医生的影响

Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.

作者信息

Reiter David

机构信息

Department of Otolaryngology-Head & Neck Surgery, Jefferson Medical College, 925 Chestnut Street, 6th Floor, Philadelphia, PA 19107, USA.

出版信息

Facial Plast Surg Clin North Am. 2007 May;15(2):247-50, vii-viii. doi: 10.1016/j.fsc.2007.01.009.

DOI:10.1016/j.fsc.2007.01.009

PMID:17544941

Abstract

Use of Food and Drug Administration-approved medications and products for other than the approved indications is common in facial plastic surgery and violates no laws. Addressing practical concerns about such use strengthens the doctor-patient relationship and can minimize the risk of successful allegations of negligence in the event of untoward outcomes. The facial plastic surgeon can find support and assistance with off-label use in two general areas. Abundant scientific literature focuses on off-label use and addresses its practical, scientific, legal, moral, and ethical issues. The Food and Drug Administration also addresses off-label use in its own publications. It offers guidelines for physicians that, if followed, facilitate incorporation of off-label use into practice with minimal risk and maximum potential for therapeutic success.

摘要

在面部整形手术中，使用美国食品药品监督管理局（FDA）批准的药物和产品用于非批准适应症的情况很常见，且不违反任何法律。解决关于这种使用的实际问题有助于加强医患关系，并在出现不良后果时，将成功指控疏忽的风险降至最低。面部整形医生可以在两个一般领域获得关于标签外使用的支持和帮助。大量科学文献关注标签外使用，并探讨了其实际、科学、法律、道德和伦理问题。美国食品药品监督管理局也在其自身出版物中讨论了标签外使用。它为医生提供了指导方针，若遵循这些方针，有助于将标签外使用纳入实践，同时风险最小化且治疗成功的潜力最大化。