Responding to concerns voiced by ASN and others in the nephrology community, the Food and Drug Administration (FDA) announced on June 2 that it has changed its plan to issue a Medication Guide to dialysis patients every time they receive an erythropoeisis stimulating agent (ESA). The FDA will now require that dialysis patients receive the Medication Guide—the primary component of the Risk Evaluation and Mitigation Strategy (REMS)—for ESAs at initiation of therapy and again if the guide is “materially revised or updated.”
Since 2008, if FDA believes a drug’s risks may outweigh its benefits, or that the drug potentially poses serious risks to patients, it mandates that the manufacturer develop a REMS. Roughly 100 REMS exist, but the components of the REMS (such as Medication Guides or monitoring programs) vary by drug. FDA instated the REMS for ESAs in February 2010. As part of the REMS for ESAs, physicians would have had to provide a five-page Medication Guide about ESAs to all patients receiving the medication—including patients with kidney disease—when an ESA is dispensed.
Shortly after the policy was put in place, many in the nephrology community, including ASN, began to raise concerns that the REMS requirements were burdensome, and could pose a barrier for some patients to access needed drugs. ASN Public Policy Board Chair Thomas Hostetter, MD, FASN, testified on three panels at an FDA hearing on the REMS program on behalf of ASN in July 2010. Leading up to this FDA decision, ASN Public Policy Board member Wolfgang Winkelmayer, MD, ScD, FASN, also presented testimony about the currently available evidence regarding the safety and efficacy of ESAs at an October 2010 meeting. Recent FDA scrutiny of ESAs has been corollary to CMS’ National Coverage Decision (NCD) investigation into ESAs, which culminated in June 2011.
In his testimony, Hostetter raised concerns about the Medication Guide’s content balance and sensitivity level. He conveyed apprehension that detailed review of the risks of ESAs (with scant information on their benefits), along with the frequency of distribution, could frighten patients away from a medication that is crucial to preserving their vitality and quality of life.
“I am extremely pleased by the FDA’s decision to limit distribution of the Medication Guide. It makes sense for patients and providers,” Hostetter said. “This was a very good outcome from ASN’s visit to the FDA last summer.”
