Advocacy News

October 13, 2015



AAOS Disappointed in Release of Meaningful Use Stage 3 Final Rules

Bonefied News

Senators Introduce Legislation to Improve Electronic Health Records

What We’re Reading

Senate HIT Hearing

Legislators Introduce Loan Forgiveness Legislation for Pediatric Subspecialists

Risk Evaluation & Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System & Patient Access

PQRS Informal Review Process

Ambulatory Surgery Center Association Meets in DC

MDEpiNet PPP Annual Meeting- October 1 -2, 2015

AAOS Orthopaedic PAC Online Contribution Center


AAOS website

AAOS Calendar

House of Representatives Legislative Activities
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Risk Evaluation & Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System & Patient Access

The Food and Drug Administration (FDA) announced a public meeting entitled, “Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access.”  The FDA hosted this meeting on October 5, 2015.  The purpose of the public meeting was to engage in constructive dialogue and information among various stakeholders concerning the impact of REMS on the healthcare delivery system, including the impact of patients and health care providers.  The meeting was built on prior stakeholder feedback on the design, implementation, and assessment of REMS obtained through public meetings, stakeholder outreach, and comments to the public docket.  There were also recommendations and suggestions recently summarized in the Agency’s report entitled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies.” 

The primary focus of the meeting was on REMS with Elements to Assure Safe Use (ETASU).  ETASU are interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient.  Some actions may also be required in order for the patient to continue on treatment.  The purpose of REMS with ETASU is that it provides safe access for patients to drugs with known serious risks that would otherwise be unavailable.  REMS are required for prescription drug and biological products when it determines that such a strategy is necessary to ensure that the benefits of a drug outweigh the risks.  The meeting also included discussion on issues that apply to all REMS and discussion that focused on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS.  

There were public comment sessions in which the FDA was seeking input on improved approaches for understanding, evaluating, and minimizing burden on the health care delivery system.  FDA presenters provided an overview of REMS, a framework for discussion regarding REMS and barriers to patient access, and presented ongoing initiatives to solicit feedback.  There is concern that there is burden on the effort that stakeholders expend in complying with the REMS requirements.  This includes the effort to complete the REMS-required training, the effort to implement a process in a health care system, and the effort to obtain specific documentation verifying the review of the required laboratory monitoring and the associated clinical decision.  There is also a concern regarding the impact on patient access and how it refers to unintended delays, interruptions, or barriers to treatment with the drug as a result of REMS.  Overall, the meeting was well attended.  The ideas and presentations from all stakeholders will be used to make REMS efficient and reduce burden to the extent possible and maintain patient access to the drug, while preserving the safe goals of the REMS.