Don’t sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S.

Journal of Pharmaceutical Policy and Practice

Stacey L. Worthy¹ 

[1] Alliance for the Adoption of Innovations in Medicine (Aimed Alliance), 1000 Potomac St. NW, Suite 150-A, Washington, DC 20007 USA

关键词: FDA;    Risk evaluation and mitigation strategies;    REMS;    Restricted distribution;    Safety;    Drugs;    Pharmaceuticals;   

DOI  :  10.1186/s40545-016-0051-0

学科分类：药理学

来源: BioMed Central

【 摘 要 】

Background

As medicines are becoming more targeted and complex in the U.S., ensuring patients’ safe use of medications with known dangerous risks is critical for public health and safety. Therefore, the Risk Evaluation and Mitigation Strategies (REMS) program is more important than ever. The REMS programs mandates that manufacturers utilize tools to manage known or potential serious risks (e.g., death, severe birth defects, prolonged hospitalization) associated with certain drugs while still making these medications available to patients with unmet medical needs. Yet, recently federal policy makers have proposed legislation to force manufacturers to sell medications with known serious risks in a manner that weakens the medications’ REMS programs.

【 授权许可】

Unknown