CDER / CBER Pharmacovigilance Working Group

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Presentation transcript:

CDER / CBER Pharmacovigilance Working Group Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment CDER / CBER Pharmacovigilance Working Group

Working Group Members Group Leads: Julie Beitz Mark Goldberger Jeff Siegel Bette Goldman Jerry Davis Roselie Bright Mary Beth Jacobs Support: Aileen Ciampa Jane Axelrad Virginia Beakes Nichelle Cherry Jane McCarthy Kathy Miracco Yi Tsong Edward Cox Dan Shames Susan Lu Joyce Weaver Marianne Mann Judy Staffa Carol Holquist Min Chen Melodi McNeil Ralph Schmid Group Leads: Julie Beitz Mark Goldberger Miles Braun Project Manager: Patrick Guinn

Workshop Agenda Morning Afternoon Overview Good Pharmacovigilance Practices Presentations, Qs and As Afternoon Pharmacoepidemiologic Assessment Closing Remarks

Scope of Concept Paper Present FDA’s preliminary thoughts on: Important pharmacovigilance concepts Safety signal identification Pharmacoepidemiologic assessment and interpretation of safety signals The development of pharmacovigilance plans

Scope of Concept Paper Focus on risk assessment based on observational data sources Case Reports, Case Series Pharmacoepidemiologic Studies Registries Surveys

What is Pharmacovigilance? All post-approval scientific and data gathering activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other product- related problems This includes the use of pharmacoepidemiologic studies

Pharmacovigilance: Why? At the time of approval, clinical trial data are available on limited numbers of patients treated for relatively short periods Once a product is marketed, large numbers of patients may be exposed, including: Patients with co-morbid illnesses Patients using concomitant medications Patients with chronic exposure

Pharmacovigilance: Why? After marketing, new safety information may become available: Through use of the product domestically or in other countries Through use of other drugs in the same class From preclinical studies From pharmacologic studies From controlled clinical trials

What is a Safety Signal? An apparent excess of adverse events associated with use of a product Even a single well-documented case report may be viewed as a signal

What is a Safety Signal? Preclinical findings or experience with other products in the class may be sufficient to generate a signal, even in the absence of case reports in patients A product’s risk profile may be characterized by several safety signals

Safety Signals Are identified Are evaluated Are interpreted From case reports, other sources Are evaluated In pharmacoepidemiologic studies, registries, surveys Are interpreted In the context of all available safety information Are monitored Through enhanced pharmacovigilance efforts

What is a Pharmacovigilance Plan? A plan proposed by a sponsor for the ongoing evaluation of safety signals identified with the use of a product to monitor at-risk populations which have not been adequately studied Plan may be developed at the time of product launch or after a signal is identified

What is a Pharmacovigilance Plan? A sponsor’s plan may involve: Expedited reporting of serious adverse events of interest Submission of adverse event report summaries at more frequent, pre-specified intervals Conduct of additional observational studies or clinical trials Implementation of active surveillance activities to identify as yet unreported adverse events

Active Surveillance May Involve... Product-based activities Follow cohorts of patients exposed to specific products Setting-based activities Surveillance of healthcare settings (e.g., EDs) for events likely to present there Event-based activities Monitor registries for events that are often drug-related (e.g., liver transplant registries)

Emerging new safety data may result in ongoing revisions to the sponsor’s pharmacovigilance plan for a product

While additional safety information is being developed, FDA will work with sponsors to: communicate information about safety signals and minimize events occurring in users of a product through risk management programs1 1Concept Paper: Risk Management Programs

Workshop Agenda Morning Afternoon Overview Good Pharmacovigilance Practices Presentations, Qs and As Afternoon Pharmacoepidemiologic Assessment Closing Remarks