Daniel, greg brookings presentation cue meeting_20120601

© 2012, The Brookings Institution

FDA’s Sentinel Initiative and
Opportunities for Public Engagement

Gregory Daniel
Fellow, Economic Studies
Managing Director, Engelberg Center for Health Care Reform
The Brookings Institution

2012 CUE Annual Membership Meeting
June 8, 2012


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

2


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
Federal Partners
Food and Drug Collaboration launched Mini- Mini-
Amendments Sentinel Sentinel
Act (FDAAA) able to able to
FDA awards Brookings
query data query data
convener grant
from 25 from 126
OMOP million million
launched FDA awards HPHC Mini- people people
Sentinel contract

2007 2008 2009 2010 2011 2012

FDA awards 8 small
project contracts
Assessment Rapid evaluation
Sentinel Initiative
initiated: of drugs for
announced
myocardial smoking
infarction and oral cessation and
hypoglycemics cardiac
outcomes


Mini-Sentinel Partner Organizations

5
Institute for Health

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?

Source: U.S. Food and Drug Administration 7


Cases of Celiac Disease in Users of Angiotensin II
Type 1 Receptor Blockers (ARBs)
0.080
Cases per 100 person

0.070
0.060
0.050
years

0.040
0.030
0.020
0.010
0.000
LOSARTAN IRBESARTAN OLMESARTAN TELMISARTAN VALSARTAN

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
Source: Mini-Sentinel


Overview of Brookings Convening Activities
Activity Description Past Topics
Roundtable Webinars Highlight pilot projects • Refer to:
relevant to active www.brookings.edu/health/projects
surveillance

Expert Workshops Focused discussions of • Methods and infrastructure
technical topics • Privacy and legal issues
• Communications
• Sentinel strategic review
• Patient and consumer engagement
Implementation Senior leaders of public • Potential organizational models
Meetings and private organizations • Participation of private sector data
discuss strategic partners and medical product developers
implementation issues

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

9


Patient and Consumer Engagement Expert
Workshop Participating Organizations
• AARP • National Alliance for Hispanic Health
• AIDS Action Baltimore • National Alliance on Mental Illness
• Alliance for Aging Research • National Coalition on Health Care
• American Cancer Society American Pain • National Health Council
Foundation Center for Democracy and • National Research Center for Women
Technology and Families
• Consumers Union • National Women's Health Network
• Crohn's and Colitis Foundation of • PatientsLikeMe
America • PFO Research Foundation
• Fabry Support and Information Group • Mini-Sentinel Planning Board
• FasterCures • Union of Concerned Scientists
• Friends of Cancer Research

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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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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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