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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, May 16, 2013

Public Summary

The following Drug Safety Communications (DSCs) have posted since the March 21, 2013 DSB meeting:

The DSB heard three presentations:

FDA Drug Safety Communication (DSC) Program

Laura L. Pincock, PharmD, MPH, Team Lead and Analyst, Safety & Risk Communication Team from CDER’s Office of Communications/Division of Health Communications discussed the CDER Drug Safety Communication (DSC) Program, covering the importance of communicating about drug risk, factors involved in issuing a DSC, including the crucial elements of why and when to communicate publically with a DSC.

Dr. Pincock noted that CDER OCOMM is committed to providing the public with up-to-date drug safety information; to careful consideration of best practices, inherent tensions, and effective mediums when communicating new and emerging drug safety information; to continued improvement of communication effectiveness, and use of research initiatives to evaluate reach and influence on behavior and perception of messaging.

Update on REMS activities

Terry Toigo, Associate Director for Safety Operations in CDER’s Office of the Center Director, presented an update to the Board on current REMS activities. She provided a brief overview of the REMS program since 2008 and highlighted the activities ongoing under the REMS Integration Initiative, particularly efforts to better standardize and evaluate REMS.

REMS experience discussion

Megan Moncur, Office of Surveillance and Epidemiology’s Division of Risk Management (DRISK), and Adam Kroetsch, Office of Program and Strategic Analysis lead a discussion and review of questions concerning REMS that were sent in advance to DSB members with clinical sites. This is part of an ongoing effort by FDA to better integrate REMS into the health care system, to decrease the burden to stakeholders, and to ultimately make REMS more effective. Additionally, FDA hopes to use feedback received today to better inform the internal working groups as they plan for a July 2013 public meeting on REMS standardization and evaluation.