FDA announces new advisory panel policies

WASHINGTON, Aug. 4 (UPI) -- The U.S. Food and Drug Administration on Monday announced several updated policies and procedures designed to improve management of its advisory committees.

The FDA said the changes include stricter limits on financial conflicts of interest for committee members, updated voting procedures and modifications of the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meeting.

"The FDA's regulatory decisions affect the health of millions of Americans and we don't make those decisions in a vacuum," said Randall Lutter, FDA deputy commissioner for policy. "It's imperative that we seek advice from independent experts and that we do so in a way that is public, open and transparent. Today's announcement strengthens our processes."

FDA advisory committees are panels of independent, outside experts who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. Last year the FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children.

Officials said all of the changes are expected to be fully implemented within 120 days.

A summary of the new policies is available at http://www.fda.gov/oc/advisory/factsheet080408.html.