Four members have resigned from the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC), and three new ones have joined. The FDA made the changes to comply with a court ruling that requires the agency to address certain members’ alleged conflicts of interests.
On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia ordered the FDA to reconstitute the TPSAC. 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.
TPSAC members Claudia Barone, Joanna Cohen and Suchitra Krishnan-Sarin, along with Chairman Jonathan Samet, have resigned or their terms on TPSAC have been terminated.
The new members are Pebbles Fagan, Gary A. Giovino and Thomas E. Novotny. The FDA is working to fill the remaining vacancy. All future TPSAC meetings will continue as planned.
In a statement, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that, while the FDA disagrees with the court’s decision, the agency has no option but to comply.
“This is a loss for the FDA and for public health,” he wrote. “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.”
The 2014 ruling is the same one that bars the FDA from using TPSAC’s 2011 Menthol Report.