FDA plans REMS studies

FDA published a draft report, "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which outlines four projects aimed at "reducing the burden of implementing" REMS for patients and healthcare practitioners.

The planned projects follow a July 2013 public meeting on REMS that was held as part of the agency's PDUFA V commitments. According to the draft report, FDA plans to conduct research into REMS patient counseling tools to improve communications about the benefits and risks of drugs that have REMS; to evaluate the feasibility of providing continuing education certification specific to a REMS; to identify an approach for using Structured Product Labeling to standardize and integrate REMS into pharmacy systems and other health IT systems, including electronic prescribing; and to develop a webpage as a "central source of REMS information." ...