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BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.
The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.
“A majority of the organizations told us they felt the REMS program needs a major overhaul and said that a REMS is a poor substitute for other improvements needed systemwide in drug education, communication, use monitoring, patient access and delivery of care,” CSDD associate director Christopher-Paul Milne said.
In addition to the three-quarters of respondents — which included drug developers, healthcare providers, insurance companies and others — who said the program needed an overhaul, and the 68% who said REMS programs are a poor substitute for other improvements, 86% said risk and benefit information were not well balanced in REMS communications, while 22% thought REMS was an improvement over the existing risk-management system.