Category: Publications

By Patrick O’Leary

Last spring I had the chance to work as a research assistant for Marc Rodwin, a Lab Fellow at Harvard’s Edmond J. Safra Center for Ethics, reading through hundreds (perhaps thousands) of pages of Congressional hearing transcripts from the 1960s and 1970s relating to the federal regulation of drugs. In reading the final version of the article that I helped to research, Independent Clinical Trials to Test Drugs: The Neglected Reform, forthcoming in Volume 6 of the Saint Louis University Journal of Health Law & Policy (also available online), two things occurred to me about the way academics and to some extent policymakers approach regulatory law, especially in the life sciences.

First, it struck me that in the general discourse about health policy, we are often surprisingly oblivious to history. Although the first U.S. law requiring safety or efficacy testing for new drugs was passed a mere 75 years ago, the intervening decades have been prolific when it comes to proposals and debate. What Rodwin’s article does, and I think is valuable both to support his own proposition and to advance the scholarship of others, is to frame his contemporary proposal with a close historical look at similar proposals and the debate surrounding them. What becomes clear, whether the topic is independent clinical testing, the “drug lag,” or the scope of patent protection and marketing exclusivity, is that our “new” ideas about how to improve the system are often anything but. The idea that we ought to know the history of our subject is not particularly groundbreaking, of course, but it’s plain we could be doing more. I’ve found that even the little history I’ve read–all those hearings, of course, but also wonderful books like Daniel Carpenter’s Reputation and Power and Philip J. Hilts’s Protecting America’s Health, and under-utilized resources like FDA’s Oral History Transcripts–has proved endlessly valuable even in thinking about cutting edge ideas like those I’m privileged to be exposed to as a participant in the Petrie-Flom Center’s Health Law Policy and Bioethics Workshop.

Second, it occurred to me that when we think and write about health policy, we might benefit from distinguishing–at least for ourselves–between two distinct projects: the practical endeavor of proposing “realistic” policy changes that take account of and purport to improve on our imperfect and historically contingent regulatory regime, on the one hand, and the more theoretical work of contemplating an ideal system, a “castle in the sky.” Folks who think deeply and write about these issues obviously engage in both: Rodwin’s article, for example, plainly takes the present framework as its starting point, but does so with the larger theoretical question in mind.  I just wonder if we might be more explicit in articulating how proposed incremental changes fit into a broader project of making the regulatory scheme look more like our hypothetical ideal. The history of regulatory law is so littered with incremental changes that have had unanticipated consequences elsewhere in the system that I would love to see more authors lay out explicitly what they hope the system will look like, and justify their incremental proposals as part of that broader vision.