Most people stopped doubting the dangers of tobacco long ago. And yet, tobacco products continue to adorn the checkout kiosks of convenience stores and appear in the pages of magazines. The question is: which of these products should be allowed and which should not? It’s no longer a theoretical question: the US Food and Drug Administration (FDA) was granted the power to regulate these products four years ago.
More research will help the FDA make tough decisions in this area, says Helen Meissner, the director of the Tobacco Regulatory Science Program at the US National Institutes of Health (NIH). Meissner is leading a joint effort with the FDA to study how to bring science-based regulation to the manufacturing, marketing and distribution of products such as cigarettes. On 19 September, the two agencies announced that they would grant a total of $53 million to 14 research teams working on tobacco-related projects across the US. Nature Medicine asked Meissner about the newly formed Tobacco Centers of Regulatory Science (TCORS) and the challenges of government-funded research in this space.
What are the biggest research goals of this new funding effort, broadly speaking?
The FDA [needs] to understand tobacco products in order to review tobacco products. They need product standards. They need to know how best to monitor compliance and enforcement, say with advertising or youth access. And they also need information on the best ways to communicate about tobacco products through media and education campaigns.
And how will the 14 centers come together and communicate?
They will be coming together through grantee meetings, so there will be collaborative activities across the centers. Although each is independent and they have different seams—as I mentioned they cover different areas—there is synergy as well across the centers. So that is the role of NIH: to convene the groups.
How often will these meetings take place?
We will have meetings at least twice a year. We will also have conference calls and webinars with the grantees to address specific scientific topics.
What are the challenges faced by the NIH regarding tobacco research?
I think the biggest challenge, really—and it’s not one that cannot be overcome—is to make that what we are supporting through this program falls within FDA’s regulatory authority. There is a lot of research that is relevant to tobacco control, that may be relevant to what FDA ultimately does, but the outcomes of the research has to be something that FDA can actually use. That has been somewhat confusing to investigators, and scientists even within NIH as well, to truly understand what is responsive and what is not responsive to FDA’s regulatory [mandate].
You mean some research proposals that aren’t related to aspects of tobacco that the FDA can regulate. Can you give an example?
For instance, treatment trials—that’s not part of the CTP’s [Center for Tobacco Products] mission. As a result, we have to review those applications for responsiveness before we even let them go to scientific review. If they are not responsive to FDA’s regulatory authorities, there is no way they could get picked up and supported through this program.
There has been a gap in the past between tobacco science and regulation. Will the science that comes of these centers have an impact?
I certainly hope so. And that’s what’s so exciting about this program, at least to me, is that here we really have an arrangement where science can have a direct impact on policy. And so often we see that much research in the sciences resulting in interventions and information that we know work often doesn’t make it into public health practice. And I think with this program we can really make a big difference.