WASHINGTON -- The U.S. Food & Drug Administration (FDA) has announced changes in membership to the Tobacco Products Scientific Advisory Committee (TPSAC), including the resignation or termination of four members and the addition of three new ones. The move follows a 2014 federal court decision that required the FDA to reconstitute TPSAC and bars the ageny's use of TPSAC's 2011 Menthol Report.
When selected, all former and current TPSAC members met the FDA's conflict of interest (COI) requirements, it said; however, the court ruling further expands FDA's COI criteria. Each voting TPSAC member was rescreened. This resulted in the resignation or termination of four members.
The court ruling was issued in a lawsuit, filed in 2011, alleging in part that certain members of TPSAC had conflicts of interest that violated ethics law.
Mitch Zeller, the director of the FDA's Center for Tobacco Products (CTP) issued the following statement:
On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia issued a ruling that requires the FDA to reconstitute the Tobacco Products Scientific Advisory Committee (TPSAC). The ruling also bars the FDA from using TPSAC's 2011 Menthol Report. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law. FDA disagrees with the decision, but Judge Leon's order is currently in effect and we must comply.
For membership on any advisory committee with the FDA, potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment and research grants, and contracts in order to permit evaluation of possible sources of conflict of interest (COI). All original and current TPSAC members successfully met the FDA's rigorous requirements upon selection; however, Judge Leon's ruling further expands the FDA's COI criteria.
As a result of the expanded COI criteria outlined in Judge Leon's ruling, each voting TPSAC member was rescreened and four members--Chairman Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin--have resigned or their terms on TPSAC have been terminated. This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service; however, in light of Judge Leon's ruling, we do not believe we are able to exercise our discretion to consider this option at this time.
All of us at the agency have appreciated the leadership, insight and expertise of Drs. Samet, Barone, Cohen and Krishnan-Sarin. We extend our sincerest gratitude for their work on the TPSAC.
At the same time, FDA would like to welcome Pebbles Fagan, Gary A. Giovino and Thomas E. Novotny as new members of TPSAC. All three of these new members have specific scientific expertise that fits the anticipated needs of the committee, and all three members meet the requirements for membership in accordance with Judge Leon's ruling and the expanded COI criteria. FDA plans to work expeditiously to fill the remaining vacancy, and all future TPSAC meetings will continue as planned.