Sept. 10, 2014
Public Citizen to FDA: Advisory Committee-Industry Revolving Door Should Be Closed
FDA Should Not Allow Recent Committee Members to Act as Hired Guns for Companies Angling for Votes of Approval by the Same Committees
WASHINGTON, D.C. – Experts who have recently served as voting members at U.S. Food and Drug Administration (FDA) advisory committee meetings should not be allowed to speak before those same committees on behalf of companies seeking favorable committee votes, Public Citizen told the agency today.
In a recent example, Dr. Milton Packer, a recurrent, temporary member and chair of the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC), was hired by Novartis Pharmaceuticals to advocate the approval of its new medication serelaxin at the March 27 meeting of the CRDAC (the medication was unanimously rejected by the committee). The FDA granted Packer permission to speak in this capacity despite his status as a long-time CRDAC member, with his most recent appearance as a voting member of the committee coming less than two months before his paid speaking role for Novartis.
Public Citizen is calling on the FDA to institute a “cooling off period” for advisory committee members, which would prohibit them from speaking or consulting on behalf of sponsors before any FDA advisory committee for a reasonable period of time following their last service on a committee. In addition, Public Citizen is urging the FDA to explicitly prohibit such paid arrangements for “core” committee members during their appointed terms of service and to take previous speaking or consulting roles at advisory committee meetings into account when considering the appointment of future committee members.
“The FDA advisory committee-industry revolving door is wide open and risks compromising the integrity of the vital committee process,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “A company’s use of respected committee members to present its case at these meetings is clearly intended to leverage the collegiality existing among committee members to increase the odds of a favorable vote. Such a revolving door creates the appearance of a conflict of interest and threatens to undermine public confidence in the objectivity of FDA advisory committee members.”