Abstract
Title IX of the 2007 Food and Drug Administration Amendments Act (FDAAA) authorizes the FDA to require pharmaceutical and biological sponsors to develop and manage a Risk Evaluation and Mitigation Strategy (REMS) program for products with certain safety issues to ensure that the benefits of the drug or biological product outweigh its risks. The ability to prescribe these agents is contingent upon compliance with the REMS requirements and enrollment in sponsor programs. It is imperative that advanced oncology practitioners become familiar with the REMS program in order to maintain access to these products and adequately and appropriately manage symptoms. The advanced oncology practitioner is key to furthering the REMS goal: to ensure the safe use of potentially harmful agents.
