Creation/Revision Date: July 26, 2010
H. Gregg Claycamp, Ph.D, Director
Division of Compliance, Risk Management, and Surveillance
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Room 4266, Mail Stop HFD-330
Silver Spring, MD 20993-0002
Subject: Risk Evaluation and Mitigation Strategy (REMS) for Erythropoeisis Stimulating Agents (ESAs)
Dear Dr. Claycamp:
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease. We are writing with regard to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for Erythropoeisis Stimulating Agents (ESAs).
RPA has a long history of advancing kidney patient safety as evidenced by RPA’s Keeping Kidney Patients Safe initiative. After conducting a health professional and kidney patient survey to identify the key areas of safety concerns in dialysis facilities, RPA convened a conference with a diverse panel of stakeholders to develop an action plan to address these concerns. RPA created a website, https://www.renalmd.org/mpage/KKPS_home, for housing resources, including best practice in kidney patient safety.
Accordingly, we support the underlying principles of the FDA’s REMS program for ESAs. RPA believes that it is appropriate for nephrologists, nephrology practitioners, and other physicians to be responsible for discussing risks associated with patients using ESAs, with the clarification that this does not infer a need for informed consent. However, in order to facilitate better informed decisions by patients, we believe that the discussion must also present the benefits of ESAs.
It is also RPA’s opinion that FDA should reconsider the need for the medication guide to be provided to patients on a monthly basis. RPA believes that the medication guide should certainly be provided at the initiation of ESA therapy, and at some periodic time interval moving forward. However, we also believe that the requirement for the medication guide to be distributed on a monthly basis adds an unnecessary burden for the clinical workforce, and over time this activity will become redundant and inefficient. Further, it could paradoxically be a less effective means of communicating the appropriate message with patients, as they may be more likely to disregard the medication guide if they receive the same information month after month. For these reasons, we urge FDA to consider revising this requirement so that the medication guide must be disseminated quarterly or even annually.
As always, the RPA appreciates the scope of FDA’s efforts in promoting patient safety with regard to the nation’s kidney disease patient population, and we look forward to future collaboration with the FDA whenever possible. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at email@example.com.
Edward R. Jones, M.D.