Document Detail


The Drug Safety and Risk Management Advisory Committee: A Case Study of Meeting Frequency, Content, and Outcomes Before and After FDAAA.
MedLine Citation:
PMID:  23047787     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: : The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making.
RESEARCH DESIGN: : We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods.
RESULTS: : DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA.
CONCLUSIONS: : Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.
Authors:
Elaine H Morrato; Sarah B Ling
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical care     Volume:  50     ISSN:  1537-1948     ISO Abbreviation:  Med Care     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0230027     Medline TA:  Med Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  970-86     Citation Subset:  IM    
Affiliation:
*Department of Health Systems, Management and Policy, Colorado School of Public Health †Department of Clinical Pharmacy, School of Pharmacy, University of Colorado, Anschutz Medical Campus, Aurora, CO ‡College of Osteopathic Medicine, Des Moines University, Des Moines, IA.
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