1. FDA Sentinel Initiative
Karen C. Lee, M.D. M.P.H.
Office of Critical Path Programs
U.S. Food and Drug Administration
October 28, 2008
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2. Summary FDA Sentinel Initiative
FDA Sentinel Initiative
Background
Vision
Current status
Potential impact on corporate compliance departments
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3. Sentinel Initiative: HHS Secretary Request to FDA (2005)
Expand current system for monitoring medical product performance
Explore possibility of working in collaboration with multiple healthcare data systems
Augment capability of identifying and evaluating product safety information beyond existing voluntary reporting systems
Strengthen ability to monitor product throughout entire life cycle
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4. Sentinel Initiative: HHS Secretary Request to FDA (2005)
Create public-private partnership
Use increasingly available large, electronic healthcare databases
Use emerging technologies and build on existing systems, rather than create new systems
Also requested by IOM report “The Future of Drug Safety – Promoting and Protecting the Health of the Public” (2006)
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5. FDA Amendments Act (FDAAA) of 2007
Reagan-Udall Foundation
Expansion of the existing ClinicalTrials.gov registry
New FDA postmarket safety authorities
RUF = a private, independent, nonprofit entity, to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety
Clinical trials.gov registry to make available to the public information, including safety information, on drugs undergoing premarket study
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6. FDAAA Section 905
Develop methods to obtain access to disparate sources of data
Develop validated methods to link and analyze safety data from multiple sources
≥ 25 million pts by July 1, 2010
≥ 100 million pts by July 1, 2012
Collaborate with public, academic, and private entities
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7. FDA Sentinel Initiative: Vision
FDA Sentinel Initiative report (May 2008)
FDA’s current vision of nationwide electronic safety monitoring system
Data remain with original owners behind existing firewalls
Owners run FDA-requested queries (or could opt out) and convey the results of their queries to the FDA for analysis (under strict privacy and security safeguards)
FDA may able to partner with existing data owners (e.g., Centers for Medicare & Medicaid Services, VA, DoD, insurance companies with large claims databases, owners of electronic health records)
Reagan-Udall Foundation to be ultimate host
Long-term project to be implemented in stages
Ultimately could facilitate various policy and technical efforts, including data standards, data mining and other research-related activities
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8. FDA Sentinel Initiative: Current Status
Earliest stages – will necessarily evolve
Create broad public forum to discuss issues related to developing and implementing the system
FDA-initiated meetings
Federal partners
Data holders
Academics and experts
Patient representatives
Consumers
Industry
Vendors
Brookings Institution
Questions esp relevant to complicance to be resolved include:
Governance (access, uses)
Primary goals & methods
Active surveillance v. data mining
Hypothesis-testing v. hypothesis-generation, signal detection v. signal evaluation
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9. FDA Sentinel Initiative: Current Status
Eight contracts recently awarded
Governance
Access, controls, business models, secondary uses, etc
Epidemiologic (6)
Data sources (3) – general, orthopedic device registries, blood and tissues
Signal detection
Medical product uptake
Database models
Engaging stakeholders
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10. FDA Sentinel Initiative: Current Status
Epidemiologic pilots
Test and validate methods to study known drug-adverse event associations to avoid regulatory actions based on invalid results
CMS
Observational Medical Outcomes Partnership
electronic Health Initiative
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11. FDA Sentinel Initiative: Potential Implications for Compliance
National resource that will serve as another tool for drug safety evaluation/surveillance
Will not replace current adverse event reporting systems
May help companies comply with current reporting requirements
21 CFR § , 21 CFR § , 21 CFR § 803
Post-marketing commitments
Drug safety monitoring as requested by FDA and/or initiated by MFRs, other potential users
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