Drug Safety Oversight Board Meeting, September 17, 2009
The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on risk communications [Public Health Advisories (PHAs), Early Communications about Ongoing Safety Reviews (ECs), and Information for Healthcare Professionals (HCP)] posted and in development since the July 16, 2009 meeting. The following is a list of the posted risk communications:
- July 16, 2009: Omalizumab (Xolair) and a Potential Pediatric Cardiovascular Signal
- July 28, 2009: Body Building Supplements
- July 30, 2009: Colchicine
- August 3, 2009: Botulinum Toxin Products
- Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)
- August 4, 2009: TNF Blockers and malignancies in children and young adults
- Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
- August 24, 2009: Orlistat and hepatotoxicity
- August 28, 2009: Leukotriene inhibitors and neuropsychiatric adverse events
- September 16, 2009: Promethazine and severe tissue injury, including gangrene
- September 16, 2009: Natalizumab and progressive multifocal leukoencephalopathy (PML)
The DSB heard presentations and discussed 4 topics: An update on the Sentinel Initiative; the DSB path forward in 2009 and beyond; the CDER Center Director’s conversation with the DSB; and a one-year follow-up on issues presented to the DSB.
An update on the Sentinel Initiative
The Scientific Lead on FDA’s Sentinel Initiative presented an overview, progress to date, and next steps in FDA’s Sentinel Initiative. The goal of the Sentinel Initiative is to develop an active electronic safety monitoring system to strengthen FDA's ability to monitor the postmarket performance of medical products. The Sentinel Initiative’s intent is to augment, not replace, existing safety monitoring systems, and to enable FDA to access existing automated healthcare data by partnering with healthcare insurance providers, academic institutions, federal and state government agencies, healthcare providers, and other owners of various electronic health records.
The Board discussed the following advantages of the Sentinel Initiative:
- Identifying and evaluating safety issues in near real time
- Expanding FDA’s capacity for evaluating safety issues
- Improving access to information on subgroups and special patient populations
- Improving precision of risk estimates because of expanded numbers of patient available for study
- Actively surveying and identifying an increased risk of common medical product-related adverse events that health care providers may not suspect are related to medical products
DSB path forward in 2009 and beyond
A DSB staff member presented the Board’s evolving role and ways of improving its purpose and function. The Board then discussed its various strengths with one of the strengths being its unique and diverse makeup. The Board consists of representative from three FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health) and six Federal Partners (the Agency for Health Care Research and Quality, Centers for Disease Control and Prevention, Department of Defense, Indian Health Service, National Institutes of Health, and Department of Veterans Affairs). The Board is in a unique position to help influence and solve public health issues.
CDER Center Director’s conversation with the Board
The CDER Center Director reviewed the Board’s historical purpose and discussed the Board’s future purpose and function. Over the last 9 months, the Board’s composition has changed by adding representatives from FDA’s Safe Use Initiative Team and 3 additional Federal Partners (representatives from the National Institutes of Health Communications staff, Department of Defense, and Indian Health Service). The Center Director emphasized an important function of the Board is to be able to discuss drug safety issues with our Federal Partners who are involved in health care but do not work for the FDA. This allows FDA to hear other perspectives on a particular drug safety issue and discuss the impact of FDA’s decisions on various drug safety issues on the healthcare systems of our Federal Partners.
One-year follow-up on issues presented to the Board
The Executive Director of the DSB presented a follow-up on DSB discussions and recommendations for topics presented to the Board from April 2008 to July 2009. The Executive Director highlighted the topics discussed, board recommendations, follow-up actions that occurred as a result of the Board’s recommendations, and incidences where FDA collaborated with Federal Partners to solve a particular drug safety issue through their membership and association on the Board.