In a letter to the Food and Drug Administration (FDA), the CME Coalition applauds the agency’s recognition—as noted in its September 2014 report—that continuing medical education (CME) plays an essential role in improving knowledge of drug-related risks. The Coalition highlights their support for the FDA’s intention to evaluate the feasibility of drug-specific REMS CME training. As detailed in the letter, “preliminary research suggests that REMS-related CME can reach substantial numbers of providers who do not otherwise choose to engage with standard REMS communication, such as a Dear Healthcare Provider letter… As noted in the FDA’s September 2014 report, REMS CME activities could be developed both for approved drugs as well as for pending drugs prior to FDA approval, with the REMS CME published or presented upon drug launch.” The Coalition goes on to suggest that plans to develop CME should include provision of resources to measure and evaluate the effect of the activities, and expresses a willingness to work with the FDA regarding priorities for REMS education, resolution of priorities and barriers, and best practices for adult learning in the CME environment as it relates to REMS.
| CME Coalition Response to FDA REMS |
