FDA Commissioner Rob Califf announced (Politico, Associated Press, New York Times) that he was asking the Regan-Udall Foundation to conduct a process review of the FDA’s tobacco and food centers. As someone who has been critical of the poor and incomplete scientific assessments FDA has completed of so-called “harm reduction” products — particularly e-cigarettes and heated tobacco products — as well as its de facto policy of allowing menthol e-cigarette to remain on the market, I agree that an outside review of the Center for Tobacco Products could be useful.
At the same time, I and others in the health community are concerned that the Regan-Udall Foundation’s lack of experience on tobacco issues that might get in the way of an even-handed evaluation of CTP.
Reagan-Udall’s CEO, Susan Winckler, previously led the Food & Drug Law Institute (FDLI) – a group that is dominated by industry lawyers – and that has regularly provided platforms for industry to promote its “harm reduction” marketing model. It is my understanding the R-U staff expertise is in pharmaceuticals and medical devices, which is a not an appropriate paradigm for tobacco regulation.
James Hildreth is on the R-U board. He is the president Meharry Medical College who accepted a $7.5 million dollar grant from Juul Labs that has been reportedly used to build their Center for the Study of Social Determinants of Health.
There are many others on the R-U board that have the potential to provide an even-handed scientific critique of FDA CTP, but ensuring that happens is going to take active engagement from the public health community and its allies in Congress and the Administration to ensure that this review doesn’t simply reinforce industry positions the way FDLI does.