Daniel, greg brookings presentation cue meeting_20120601

© 2012, The Brookings Institution

FDA’s Sentinel Initiative and Opportunities for Public Engagement

Gregory DanielFellow, Economic Studies

Managing Director, Engelberg Center for Health Care ReformThe Brookings Institution

2012 CUE Annual Membership Meeting June 8, 2012

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Importance of Postmarket Safety Surveillance

• All products have some risk• Monitor drugs throughout the product’s lifecycle• At the time of approval, clinical trials have demonstrated

that the benefits of the product outweigh risks• Once the product is on the market, the product is used in

more patients and in a more diverse population than was tested in clinical trials

• With broader use, can also detect rare adverse events


Sentinel Initiative: Public-Private Collaboration

• Established by FDAAA (2007)• Requires FDA to collaborate with public and private holders of

data on medical product use and outcomes on a common strategy and methods for broad-based active surveillance

• Set milestones for capacity for active surveillance: data drawn from care of 25 million patients by 2010, 100 million patients by 2012

• 4 activities: – Mini-Sentinel – Observational Medical Outcomes Partnership– Federal Partners Collaboration– Brookings Convening Activities

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Timeline of the Sentinel Initiative

2008 2009 2010

Food and Drug Amendments Act (FDAAA)

OMOP launched

Sentinel Initiative announced

FDA awards 8 small project contracts

FDA awards Brookings convener grant

FDA awards HPHC Mini-Sentinel contract

Mini-Sentinel able to

query data from 25 million people

2007 2011 2012

Mini-Sentinel able to

query data from 126 million people

Assessment initiated:

myocardial infarction and oral hypoglycemics

Rapid evaluation of drugs for

smoking cessation and

cardiac outcomes

Federal Partners Collaboration launched


Mini-Sentinel Partner Organizations

Institute for Health5

Source: Mini-Sentinel


Mini-Sentinel’s Distributed Data System

Source: U.S. Food and Drug Administration 6


Example of a Mini-Sentinel Assessment

• Potential “signal” identified from FDA reports that olmesartan might cause more celiac disease than other drugs in its class

• Mini-Sentinel question: How many patients taking olmesartan had developed celiac disease compared to those taking other similar drugs for high blood pressure?

7Source: U.S. Food and Drug Administration


Cases of Celiac Disease in Users of Angiotensin II Type 1 Receptor Blockers (ARBs)

Source: Mini-Sentinel

LOSARTAN IRBESARTAN OLMESARTAN TELMISARTAN VALSARTAN0.000

0.010

0.020

0.030

0.040

0.050

0.060

0.070

0.080

Cas

es p

er 1

00 p

erso

n

year

s

Cases 63 10 17 5 50

New users 235,630 40,071 81,560 24,596 153,159

ARBs: New users after >365 day washout; Celiac Disease: 1st dx code after >365 day without diagnosis. 8


Overview of Brookings Convening Activities

Activity Description Past TopicsRoundtable Webinars

Highlight pilot projects relevant to active surveillance

• Refer to: www.brookings.edu/health/projects

Expert Workshops Focused discussions of technical topics

• Methods and infrastructure• Privacy and legal issues• Communications• Sentinel strategic review• Patient and consumer engagement

Implementation Meetings

Senior leaders of public and private organizations discuss strategic implementation issues

• Potential organizational models• Participation of private sector data

partners and medical product developers

Public Stakeholder Workshops

Large, annual meetings provide a forum to engage the public in dialogue about the direction of Sentinel’s activities

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Patient and Consumer Engagement Expert Workshop Participating Organizations• AARP • AIDS Action Baltimore • Alliance for Aging Research • American Cancer Society American Pain

Foundation Center for Democracy and Technology

• Consumers Union • Crohn's and Colitis Foundation of

America • Fabry Support and Information Group • FasterCures • Friends of Cancer Research

• National Alliance for Hispanic Health • National Alliance on Mental Illness • National Coalition on Health Care • National Health Council • National Research Center for Women

and Families • National Women's Health Network • PatientsLikeMe • PFO Research Foundation • Mini-Sentinel Planning Board • Union of Concerned Scientists

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Patient and Consumer Engagement Expert Workshop Objectives

• Provide meeting participants with an overview of the Sentinel Initiative;

• Discuss opportunities for further patient and consumer engagement; and

• Discuss concrete next steps for evolving patient and consumer engagement.

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Patient and Consumer Engagement Expert Workshop Key Takeaways

• Educating the public about Sentinel: – One tool in the tool box– FDA’s avenues for communicating information about

drug safety concerns– Role of third part organizations to help raise the

national understanding of Sentinel • Spectrum of patient and consumer informational needs

– Mini-Sentinel website vs. FDA’s Drug Safety Communications

– Role of third party organizations to help patients and consumers use information appropriately

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Opportunities for public engagement

• FDA’s Office of Special Health Issues activities• Brookings convening activities:

– Annual public meeting– Webinars

• Information about drug safety concerns available through FDA’s Drug Safety Communications

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Thank you!

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Daniel, greg brookings presentation cue meeting_20120601

Health & Medicine

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brookings institutionexample

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class minisentinel question

national research center

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medical product use

active surveillance