Congressional Civil Justice Caucus Academy Briefing: The FDA Advisory Committee Selection Process: Do Financial Conflicts of Interest Affect Outcomes?
Event Date: Monday, June 10 to Monday, June 10, 2013
Location: Rayburn House Office Building, Room 2237, Washington, DC
The Food and Drug Administration (FDA) implements a rigorous review process to determine whether drugs and medical devices are sufficiently safe and effective to be sold to consumers. In some cases, the FDA relies on Advisory Committees made up of external experts to help make approval decisions with respect to drugs that may require highly specialized knowledge. As these experts have such unique qualifications, they are highly sought after in the private sector, which often leads to financial ties to drug companies.
Some have expressed concern that these financial ties will cause experts to be biased in favor of drug approvals, leading to unsafe and ineffective drugs on the market. However, others have pointed out that stringent rules limiting conflicted members from serving on Advisory Committees could reduce the competence of FDA decision-making.
Please join us for a briefing on the initial results of the Law & Economics Center's Searle Civil Justice Institute's large-scale empirical study on these conflicts of interest. Hill Country Barbeque will be served after the discussion at 12:00, so please RSVP as space is limited.
Remarks will be given by the below experts:
Presenter and Report Author
Joseph Golec, Professor, University of Connecticut School of Business
Diane Dorman, Vice President, National Organization for Rare Disorders
Diana Zuckerman, President, National Research Center for Women & Families
Randall Lutter, Visiting Scholar, Resources for the Future; Former Chief Economist and Deputy Commissioner for Policy, US Food and Drug Administration
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