FDA's Sentinel Initiative - News and Events

FDA is committed to an open public process that will enable information to be disseminated and stakeholder contributions to be gathered as it explores the scientific, technical, and policy issues that will affect the Sentinel System’s development.

Upcoming Events

Brookings Webinar: Active Medical Product Surveillance RoundtableFindings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception

Please join the upcoming Engelberg Center for Health Care Reform webinar, “Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception,” Tuesday, July 23, 2013, from 2:00 PM to 3:00 PM EDT.

RotaTeq (Merck and Co., Inc.) and Rotarix (GlaxoSmithKline Biologicals) are vaccines for the prevention of rotavirus gastroenteritis in infants 6 weeks to 32 weeks of age (RotaTeq) and infants 6 weeks to 24 weeks of age (Rotarix). Intussusception, a form of bowel obstruction, has been an outcome of interest since an older rotavirus vaccine, RotaShield, was voluntarily withdrawn from the market by the manufacturer after studies suggested an elevated risk of intussusception, estimated at approximately 1 case per 10,000 vaccine recipients. RotaShield was the first licensed vaccine for the prevention of rotavirus infection in infants.

Prior to licensing RotaTeq and Rotarix, the risk of intussusception was assessed in large clinical trials of more than 60,000 children for each vaccine. No increased risk for intussusception was observed for either vaccine. However, several postlicensure studies conducted in other countries subsequently suggested potential increased risk of intussusception after vaccination with both Rotarix and RotaTeq. In 2010, the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) initiated a study to quantify this possible risk among U.S. infants. The recently completed study was conducted through the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, a component of the Mini-Sentinel pilot developed to conduct active surveillance for medical product safety. Investigators found an increased risk of intussusception after vaccination with the first dose of RotaTeq; the data regarding the risk after Rotarix vaccination were inconclusive.

In response, FDA approved required revisions to the Prescribing Information for RotaTeq that describe the new findings from this Mini-Sentinel PRISM study. New information was added to the Highlights, the existing intussusception subsection of the Warnings and Precautions section, and the Post-Marketing Experience section of the Full Prescribing Information.

Michael Nguyen, Deputy Director in the Division of Epidemiology at CBER, will provide a brief description of the rationale for conducting this study, along with Katherine Yih, epidemiologist and lecturer at Harvard Pilgrim Health Care Institute and Harvard Medical School, who will present an overview of findings from the medical product assessment.

For a full agenda, visit: http://www.cvent.com/d/tcqhgv

Registration for this webinar is required. Register at: http://www.cvent.com/d/tcqhgv/4W

Past Events

Brookings Roundtables on Active Medical ProductsConvened by the Engelberg Center for Health Care Reform at Brookings, roundtables provide a forum to discuss public and private initiatives that are developing methods, data sources, and technology relevant to active medical product surveillance. These roundtables are intended to ensure that a broad range of stakeholders are informed about and engaged in current and upcoming activities related to medical product surveillance. These one-hour conference calls/webinars are free and open to the public.

To view previous webinars, please click on the link below:
http://www.brookings.edu/about/centers/health/projects/surveillance/roundtables

Fifth Annual Sentinel Initiative Public WorkshopThursday, January 31, 2013, 9:00 a.m. - 4:00 p.m.
Washington Marriott Wardman Park | 2660 Woodley Road | Washington, D.C.

Hosted by the Engelberg Center for Health Care Reform at Brookings, this public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including the follwoing:

An update on the U.S. Food and Drug Administration's Sentinel Initiative, including current activities and future plans;
An overview of findings from Mini-Sentinel protocol based evaluations;
Discussion of current and future collaborations and initiative expansions; and
Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety issues that require regulatory actions.

Event summary and materials are available at http://www.brookings.edu/events/2013/01/31-sentinel-public-workshop

Fourth Annual Sentinel Initiative Public Workshop
Wednesday, January 18, 2012, 8:30 a.m. - 12:30 p.m.
Washington Marriott at Metro Center | 775 12th Street NW | Washington, DC

Hosted by the Engelberg Center for Health Care Reform at Brookings, this half-day public workshop brought together the stakeholder community for a productive discussion on the future direction of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative, including remarks from FDA leadership about near-term priorities; an update on Mini-Sentinel's accomplishments in 2011; and comments from stakeholder representatives on Sentinel's progress.

Event summary and materials are available at http://www.brookings.edu/events/2012/01/18-sentinel-public-workshop

Third Annual Sentinel Initiative Public Workshop
Wednesday, January 12, 2011, 8:30 a.m. – 4:30 p.m.

Hosted by the Engelberg Center for Health Care Reform at Brookings, this one-day public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including:
– An update on Mini-Sentinel and related activities;
– Near-term plans for FDA's Sentinel Initiative; and
– Opportunities for coordination with other U.S. Department of Health and Human Services’ efforts that use distributed systems of automated health care data.Event summary and materials are available at http://www.brookings.edu/events/2011/01/12-sentinel-workshop

Second Annual Sentinel Initiative Public WorkshopJanuary 11, 2010, 8:30 a.m. – 4:45 p.m.
Washington Marriott at Metro Center, 775 12th St, NW, Washington DCOn January 11, 2010, the Engelberg Center for Health Care Reform at Brookings will convene the 2nd Annual Sentinel Initiative Public Workshop in Washington, DC. Supported by a grant from Food and Drug Administration (FDA), this one-day workshop will communicate the current status and future vision of active medical product surveillance activities and explore stakeholder perspectives on a broad range of issues. The workshop will feature:

a series of presentations on recently completed FDA contracts to inform various aspects of the Sentinel System's development
an update on FDA’s ongoing pilot projects in active surveillance of medical product safety
a discussion of three issues of broad interest:

maintaining patient privacy while conducting medical product safety surveillance
developing the Sentinel System as a national resource for medical product safety surveillance that would allow access to others beyond FDA
creating a multi-purpose distributed system to conduct safety surveillance work, comparative effectiveness research, and product quality assessment, as well as address other types of public health questions.

Event summary and materials are available at http://www.brookings.edu/events/2010/01/11-sentinel-workshop

Sentinel Initiative: Structure, Function, and Scope: December 16, 2008
A day-long public workshop on FDA's Sentinel Initiative was held in Washington D.C. on December 16, 2008. The workshop was cosponsored by the Food and Drug Administration and the eHealth Initiative Foundation and convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop brought together a diverse group of stakeholders, including academia, government, patient, consumer, and provider groups, payers, industry, and other interested organizations. Participants were given an update on the Sentinel Initiative’s status and their comments were welcomed. Discussion topics ranged from potential governance models and their implications to approaches for ensuring continued involvement of all stakeholders as the Initiative evolves.
The Federal Register notice, meeting agenda and transcript of the December 16, 2008 meeting are available in the links provided.

Sentinel Network Public Meeting: March 7 and 8, 2007
A two-day public meeting that brought together stakeholders to begin discussions on creating a Sentinel system was held in Washington, D.C. on March 7 and 8, 2007. The meeting’s purpose was to:

evaluate current needs in postmarket medical product adverse-event data collection, risk identification and analysis;
better understand and identify gaps between what a range of stakeholders are doing and what they would like to do; and
determine obstacles to facilitating or providing incentives for the creation of components needed to close the gaps and connect these various efforts into a Sentinel system.

The meeting also sought to identify opportunities for public-private collaborations for assembling data and conducting research and analysis.
The Federal Register notice, meeting agenda and transcript (March 7 and March 8) of the March 7 and 8, 2007 meeting are available in the links provided.

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