title: The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.
abstract: 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.
  
  
  METHODS
  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.affiliation: Department of Health Systems, Management and Policy, Colorado School of Public Health, CO, USA. elaine.morrato@ucdenver.edu
authors.forename: Elaine H
authors.initials: EH
authors.lastname: Morrato
authors.forename: Sarah B
authors.initials: SB
authors.lastname: Ling
mesh_terms: D026683:Advisory Committees / Q000706:statistics & numerical data*; D006801:Humans; D019982:Organizational Case Studies; D012308:Risk Management / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000706:statistics & numerical data*