I recently returned from the 2014 Public Health Law Conference, a fantastic event held every two years in Atlanta and hosted by the Network for Public Health Law, the American Society of Law, Medicine and Ethics, and the Robert Wood Johnson Foundation. Presentations at the conference covered a wide range of issues from Ebola (the topic of the day) to implementation of the Affordable Care Act to regulating junk food marketing.
I led a panel entitled Tobacco Regulatory Science: Bridging the Gap Between Science and Law. (My slides are here.) The session focused on tobacco policy, but the concern about the disconnect between researchers and attorneys applies broadly to a wide range of regulatory issues.
To grossly overgeneralize, scientists are primarily focused on advancing science. Their research agenda is driven by gaps in the literature (and by the availability of funding), not by a desire to inform regulatory decisions. Most scientists do not spend much time thinking about the implications of their research for law and policy or actively engaging with policymakers. They often see law and policy as a completely distinct domain. To the extent they think about law, it’s often in frustration, as in “Why doesn’t the law reflect what we know about science?”
On the flip side, attorneys and policymakers act in much the same way. They are also focused inward. Their primary concern is with developing new policies, enforcing them, or defending them in court. They will of course use scientific evidence that supports their case, but they’re generally not involved in the creation of such evidence and have little understanding of that process. They also may be frustrated about scientists, wondering why scientists aren’t focusing on the questions that matter to regulators or to courts.
In the tobacco context, the FDA has engaged in an interesting experiment intended to (at least partially) bridge this divide. It has invested a huge amount of funding in Tobacco Centers of Regulatory Science (TCORS). These 14 academic centers are explicitly tasked with conducting research that will help to inform the FDA’s regulation of tobacco. (I am a steering committee member of Ohio State’s TCORS center.) This is an exciting project, but puts researchers and an unusual—and somewhat uncomfortable—position. They know how to conduct research, but often do not have a great sense of the regulatory system and how science feeds into that process. This creates an ideal opportunity for attorneys and scientists to collaborate. Working together, they can (1) ensure that the research questions being asked are relevant and useful for the FDA; (2) think creatively about new ways the FDA could use its authority; (3) explain why research findings are important to the FDA; and (4) present their findings in ways that are understandable to non-scientific audiences and to the courts.
In addition to me, the panel included two speakers working to bridge the gap between researchers and attorneys from opposite directions. One was Annice Kim, a scientist from RTI International doing creative research intended to help predict the effects of potential tobacco control policies (like this). The other was Ian McLaughlin, an attorney with ChangeLab Solutions who is working with researches at the University of North Carolina to help ensure that the science being conducted will help to answer the questions courts are likely to ask when tobacco regulations are challenged. Both of them are also affiliated with TCORS centers.
There has been a lot of research on tobacco, but because federal tobacco regulation is new, there are still substantial research gaps relating to key issues like tobacco product standards (i.e., the regulation of the product itself). The TCORS model is not without its problems, but it is a creative attempt to ensure that much-needed policy-relevant research is conducted in a relatively short timeframe. I’m interested to hear what others think of this model.