Pharmaceutical & Drug Policy
Incorporating information on therapeutic alternatives into the IRA prescription drug negotiations
The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.
Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.
Agenda
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May 18
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Incorporating continuing education into REMS
9:10 am - 9:25 am
CMClaudia Manzo Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration -
Lessons from the ER/LA opioid REMS development process
9:25 am - 10:00 am
LKLinda Kitlinski REMS Education Consultant and Retired Co-Chair of RPC CE Sub-teamKRKate Regnier Executive Vice President - Accreditation Council for Continuing Medical EducationTTTerry Toigo Associate Director of Drug Safety Operations, Office of the Center Director - U.S. Food and Drug Administration -
Session I: Defining the critical elements that are essential for CE as part of a REMS
10:00 am - 11:00 am
MCMaureen Cahill Associate, Nursing Regulation - National Council of State Boards of NursingKCKathy Chappell Vice President, Accreditation Program and Institute for Credentialing Research - American Nurses Credentialing CenterAGAnne Grupe Director, Continuing Medical Education - American Society of Clinical OncologyRSRachel Sobel Senior Director, Epidemiology - PfizerJWJulie Webb Vice President, Office of Professional Development - American Society of Health-System Pharmacists -
Session II: CE programs for single drug REMS: Developing valid and high-impact content
11:15 am - 12:30 pm
GAGary Appio Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals CorporationKGKishore Gopu Director, REMS Operations - TevaEPEric Peterson Senior Director, Performance Improvement CME - American Academy of Physician AssistantsPVPeter Vlasses Executive Director - Accreditation Council for Pharmacy EducationJWJulie White Director, The Barry M. Manuel Office of Continuing Medical Education - Boston University School of Medicine -
Session III: CE programs for single drug REMS: Best-practices for implementation and uptake
1:30 pm - 2:45 pm
PCPaul Coplan Executive Director, Risk Management and Epidemiology - Purdue PharmaceuticalsEDEric Davis Director of Medical Services - MylanCGCyndi Grimes Director, Continuing Medical Education - MedscapeSKSimone Karp Chief Business Officer - CECity
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