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U.S. Department of Health and Human Services

About FDA

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Drug Safety Oversight Board Meeting, July 19, 2012

Public Summary

The DSB discussed three topics:

  1. Update to Commercial Web Sites Accessing and/or Offering FDA Adverse Event Reporting System (AERS) Data
  2. CDER’s Evaluation of Drug Safety Communications
  3. Introduction of Clozapine Registries for Future Board Input

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective federal agency or institution.

Update to Commercial Web Sites Accessing and/or Offering FDA Adverse Event Reporting System (AERS) Data

At the March 2012 DSB meeting, Board members requested additional information regarding commercial purveyors of FDA’s Adverse Event (AE) safety data. Dr. Lauren Choi from the Office of Surveillance and Epidemiology’s Division of Pharmacovigilance (DPV) returned to update DSB members of information collected from stakeholders since her previous presentation. At this meeting, the presenter outlined findings from vendor interviews, summarized current searchable AE databases, and discussed potential next steps for the Agency to meet online and social media demands.

CDER’s Evaluation of Drug Safety Communications: Risk Communication Research: What Have We Learned?

The DSB heard a presentation from Greg Busse, Ph.D., CDER Office of Communications. Dr. Busse continued in what has been a series of discussions about how CDER communicates drug safety information—through what channels, to what effect both before and after issue of a Drug Safety Communication (DSC), and in what directions CDER should move in maintaining and/or improving effectiveness of its safety information dissemination.

Drug Registries

The DSB heard from Kimberly Lehrfeld, PharmD, of the Division of Risk Management within CDER’s Office of Surveillance and Epidemiology. She discussed drug and patient registries and the history behind risk mitigation efforts as related to registries. The Board discussed the benefits of registries in reducing morbidity and mortality through effective post-market surveillance.