FDA reviews its rules for drug panels

July 25, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- The Food and Drug Administration is re-examining the rules that govern appointments to its panels of outside experts that recommend whether the agency should approve new drugs for sale, an FDA official said yesterday.

Liberal interest groups have attacked the scientific integrity of the FDA's advisory panels, saying the agency has allowed doctors and scientists to serve on them despite their ties to companies with financial stakes in the committees' actions.

Dr. Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs, said the agency wants to clarify the reasons for allowing an expert to serve when there are conflicts of interest and the circumstances for publicly disclosing such waivers.

"We are going to aim to be much more transparent about the waivers we grant and the relationships of our advisory panel members," Gottlieb said during a forum organized by the Center for Science in the Public Interest.

Gottlieb defended the agency's practice of granting waivers to scientists, saying it ensures that the FDA gets the advice of top experts.

Merrill Goozner, director of the CSPI's integrity program, said the FDA could find leading experts who don't have conflicts if it wanted to.

Democratic Rep. Maurice D. Hinchey of New York, who sponsored legislation that would bar scientists with conflicts from serving on the advisory boards, issued a statement assailing the FDA's re-examination of waiver rules as "not enough" and calling it a veiled effort to preserve its ability to grant waivers.

The FDA disqualified scientists with conflicts 1 percent of the time, a study of drug panel meetings from 2001 to 2004 found.

jonathan.rockoff@baltsun.com

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