The oncology community, including providers, patients, and industry and the U.S. Food and Drug Administration, should continue to work together to improve the agency’s Risk Evaluation and Mitigation Strategies (REMS) program, according to the report of the ASCO REMS Working Group published online by the Journal of Oncology Practice.
The report summarizes an ASCO-hosted workshop in 2011. It also highlights ongoing oncology community activities and several FDA actions to accomplish the goals of promoting safe use of oncology products and addressing the challenges of REMS programs.
On July 27, 2011, oncologists, hematologists, oncology nurses, pharmacists, patient advocates, the pharmaceutical industry and FDA officials came together to address oncology community stakeholder concerns and to discuss possible alternative approaches for the management of certain oncology and hematology drugs with REMS reporting requirements. Providers and the FDA share a common goal of ensuring that cancer patients receive safe and effective care, but experience with the REMS programs has demonstrated that some aspects of the programs don’t enhance and sometimes detract from patient care.
“Our report notes that oncology REMS programs should supplement, not duplicate, the education, experience and clinical tools that providers already have for managing safety concerns,” said James N. Frame, MD, FACP, chair of ASCO’s REMS Working Group. “The FDA has proposed some meaningful steps to improve the REMS programs. ASCO is eager and well-positioned to work with the agency and drug manufacturers to build on the opportunity to improve care for our patients.”