Look at a map of Washington, DC and surrounding Maryland suburbs, head northeast from the tip of the city, and you can make out the headquarters of the US Food and Drug Administration at White Oak, just above the beltway. It’s not far from the NIH campus, home of the federal agency that promotes and funds medical research and implementation science, as Suzanne Huertin-Roberts noted in this series. But it’s at FDA where the pharmacologic and device-related discovery, more often in translation by the work of private firms, gets evaluated as fit or unfit for the US marketplace. This is the home of regulatory science.
Regulatory science is officially defined as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.” This is no small order, with FDA currently regulating products accounting for about 25 cents of every U.S. consumer dollar, including some 10% of all imports arriving from over ¼ million facilities in 150 countries. Nearly 2/3 of the fruits and vegetables and over 80% of the seafood we eat is imported. While the primary burden of substandard and falsified medicines falls on low- and middle-income countries, the U.S. and other higher-income countries are far from immune from the risks as recent events have shown. In addition to the risks posed by domestic bad actors, we rely on global sources for both drug ingredients and finished drugs (40% at last count).
The anthropologist reading this may see a field of social process, contested terrain ripe for analyzing discourse, and cultural spaces that invite anthropological imagination. But it’s the day-to-day business of regulatory science that provides opportunities for practicing anthropology within FDA. Much of the concern is with risk communication, and there are social science groups both in the Office of the Commissioner and the Office of Prescription Drug Promotion working on ways to better deliver information, ensure understanding, influence behavior, and evaluate communication effectiveness about regulated products. In the Center for Drug Evaluation and Research (CDER) I’ve had the opportunity to contribute to efforts for improving patient-focused measures in clinical trials for drug development and currently examine assessments of over-the-counter label testing. Colleagues evaluate usability of medical devices while others work in food safety. Social and behavioral scientists are valued and engaged members of a growing proportion of multidisciplinary teams at FDA. This is work that gets us up in the morning.
The public sector difference
A critical sociology of science is generally not part of our job descriptions at FDA. This is just as well as we have plenty to do otherwise, given a mission related to protection and promotion of public health. A little well-placed authoritative knowledge can be a very good thing.
In this regard, there are many discussions we just don’t have at the table. The question, “does society really need this product?” comes to mind in particular. In CDER, we are tasked with evaluating effectiveness and safety. Effectiveness in the United States usually means better than a placebo, but can also be measured as “non-inferiority” to a standard of care. Safety is often a weight-of-evidence consensus about risks and benefits, informed by the evidence submitted and best expert opinion we can muster. We learn in our first days at the Agency the FDA neither regulates the business of pharmaceuticals nor the practice of medicine. And other regulatory authorities are clearly limited. For example, much as some wish it were so, FDA cannot outlaw tobacco but is instead tasked with its regulation.
On any given day, FDA’s location at what was once the Naval Ordnance Laboratory seems particularly apt. One morning may find our Commissioner facing a less than warm reception on Capitol Hill, seeking regulatory authorities to inspect businesses we were previously not legally empowered to do something about. On the same day an industry trade sheet might excoriate us for impeding innovation and slowing economic progress, a consumer advocate may be quoted in the newspaper taking us to task for negligent oversight and failures to protect the public health. On the best of days, we are able and privileged to shed some light on that line between medical hope and hype.
FDA may not be the place for those who need to feel the love every day. But it is an engaging and fascinating home for those who want to practice anthropology at the intersection of science, law, business, and regulatory policy. Regulatory science will continue as a growing area for applied social and behavioral science in health and medicine. I highly recommend it as a professional path for those with an orientation toward public service, policy, and those developing some background in public health and science.
James P Stansbury PhD, MPH is a Consumer Safety Officer with the Center for Drug Evaluation and Research (CDER), FDA. Stansbury has done research and evaluations in Latin America and Africa, as well as domestic health services research and trial coordination. Since joining FDA in 2010, Stansbury has focused on the evaluation of drug development tools used in clinical studies and regulatory science. He received a BA and an MA in anthropology from U of New Mexico, the PhD in medical anthropology from the U of Kentucky, and a Master of Public Health from the Johns Hopkins, Bloomberg School of Public Health.
Author Statement: This article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Sarah Ono, Heather Schacht Reisinger and Samantha L Solimeo are contributing editors of Anthropology in the Public Sector.