Cary Coglianese is the Edward B. Shils Professor of Law and the director of the Penn Program on Regulation at the University of Pennsylvania Law School. He specializes in the study of regulation and regulatory processes, with an emphasis on the empirical evaluation of alternative regulatory strategies and the role of public participation, negotiation and business-government relations in policy making. He has written extensively on the topic of regulation, including many published articles, book chapters and books. He served as editor of, and contributor to, the 2016 book, Achieving Regulatory Excellence.
I interviewed Coglianese as part of the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds. In contrast to previous interview subjects in the series, he is not himself a regulatory professional or a RAPS member, and his study of regulation extends beyond healthcare to other sectors, such as energy, communications and financial markets. The interview has been divided into two parts. In part one, he shared his thoughts on regulatory excellence, the respective roles of regulators and regulated industry, popular criticism of regulation as overly burdensome to business and more. Following, in part two, he answers questions about regulatory harmonization, trends to watch and his own personal values, among other topics.
Do you think efforts to harmonize regulations among different national and regional authorities, such as the US Food and Drug Administration and the European Medicines Agency, improves regulation? Does it improve public health? Are there drawbacks?
In the abstract, harmonization does not make regulation either better or worse. After all, harmonizing ineffectual and unduly burdensome regulations will make them more compatible—but they will still be ineffectual and burdensome. On the other hand, assuming that different societies have similar preferences and values, then harmonizing their sensible and effective—but otherwise incompatible—regulations can provide benefits by facilitating trade, which not only may result in its own welfare benefits but also may enhance public health by encouraging innovation through making larger markets available to innovators. Regulatory cooperation across jurisdictions is also helpful when it takes advantage of administrative economies of scale, fosters information-sharing, and encourages regulatory learning and experimentation. As with many other policy choices related to regulation, though, decisions about harmonization cannot be made in the abstract and need to be carefully analyzed in each setting.
Do you have any predictions for the future of healthcare product regulation?
Two emerging developments—product customization and decentralized production—will raise significant challenges for the future of regulation. Advances in precision medicine are enabling health professionals to customize highly specified medical treatments designed to fit each patient’s unique genetic and physical characteristics, potentially yielding much improved outcomes. This customization might in the future be supported by a highly decentralized network of manufacturing sites for healthcare products, with production in some cases even occurring at the individual level through the use of 3D printing. These two trends are exciting and they do promise patients potential improvements in medical treatment. But they also do not fit well with existing regulatory systems.
Current drug and device testing generally demands premarketing trials of sample sizes sufficiently large to make valid inferences. But when product formulas and other characteristics start to be customized to the level of individuals, how does a regulatory model based on clinical trials work? Furthermore, how will quality control regulation—enforcement of good manufacturing practices—work in a world of highly distributed manufacturing? Already regulators face a large number of manufacturing facilities to oversee, many outside their own national borders. But the number of manufacturing “facilities” will increase exponentially under conditions where every doctor’s office or patient’s home can effectively become a product manufacturing facility through the use of a 3D printer.
These types of regulatory challenges are starting to emerge in other areas of regulation too, raising a general need for, as I have put it in a recent paper, “optimizing government for an optimizing economy.” Traditionally, regulation has operated by making generalizations; we call many of these generalizations “rules.” As law has tended to move in an increasingly generalized way in recent decades toward more rules, the world of business and technology has, with advances in machine learning, started to become more targeted and individualized. Government needs to recognize this shift and start building the human capital needed to create new oversight approaches that fit better in an increasingly individualized and distributed world.
What skills or attributes do you think are required to succeed in a regulatory career—both on the industry and government sides?
The specific skills needed by different regulatory professionals vary depending on their roles in public- or private-sector organizations. Lawyers need different skills than risk analysts and senior managers need different skills than inspectors or auditors. But even specialists have to be adept at deploying insights from a broad range of academic and professional disciplines. That’s one reason we offer executive education in regulatory analysis and decision-making at the Penn Program on Regulation.
Regulatory professionals need to apply their general analytic skills in varying contexts, with particular problems in mind. As a result, they need to know a lot about the industry—whether they are working in the industry or in government. They need to understand the problems that regulation aims to solve in that industry—what causes these problems, what conditions exacerbate them and so forth. They also need to know about the technological, scientific and business aspects of the industry and how they contribute to problems as well as provide opportunities and constraints for regulatory solutions.
No matter what their professional role, individuals will do well to keep in mind the three attributes that make up the RegX molecule: utmost integrity, stellar competence and empathic engagement. Of course, the molecular metaphor is just a simplification and I recognize that different careers will demand more of one of these atoms more than others. But they all do matter for any position.
And simplification into three core attributes is helpful because, quite frankly, the full set of fine-grained attributes of a successful regulatory professional is simply too large for any us to keep in mind. In numerous interviews and focus groups, I’ve asked hundreds of people what they think makes a regulator excellent, and collectively I’ve heard mentioned just about every positive adjective in the English language (except those for physical beauty, taste and smell!).
An excellent regulator, for example, should be intelligent, trustworthy, humble, courageous, responsive, and so forth. (Sometimes specific attributes lie in tension with each other—such being both firm and flexible—with the need to find an optimum along a spectrum.) As a result, by distilling the attributes of excellence into core features and a simple RegX molecule, rather than trying to keep dozens of more specific qualities in mind, we can focus on major priorities. I encourage my students to think hard about what integrity, competence and empathy mean to their own work, throughout their careers. Self-reflective professionals will assess their own traits, actions and performance in terms of each of the core attributes. None of us will be perfect—and regulatory excellence does not demand perfection—but we all can be striving to improve.
Do your personal values influence your work? If so, how?
I care about people, and regulation ultimately should aim to help people by improving their well-being and ensuring everyone is treated with dignity and respect. I also like to think that I value having an open mind. This value underlies both my interest in promoting evidence-based regulatory decision-making—that is, letting the chips fall where they may—and my willingness to listen to and learn from a broad range of policy perspectives.
Some readers of my work have suggested an influence of the American philosophical tradition of pragmatism, and I’m not necessarily averse to that connection. If those of us who study regulation can do our part to advance knowledge and help decisionmakers fix problems and improve people’s lives and livelihoods, that seems to me a good thing.
What book would you most recommend to regulatory professionals and why?
It’s hard to single out any one book because regulatory professionals need to know so much. I’m currently finishing a book, The Handbook for Regulators, which, once published, will be my answer anytime someone asks, “What one book should I read?” Targeted especially to regulatory practitioners, The Handbook seeks to distill the state of knowledge in the broad range of relevant disciplines and offers fundamentals on the range of tools that regulatory professionals need to know how to use, such as benefit-cost analysis, risk analysis, program evaluation, enforcement strategies and much more.
Other than that, I can suggest a few already-published books that stand out. Eugene Bardach’s classic guide to policy analysis—A Practical Guide for Policy Analysis: The Eightfold Path to More Effective Problem Solving—remains the most accessible treatment of how to think systematically about problem-solving in a public policy context. Although Bardach is not focused exclusively on regulation, every regulator needs to know how to solve problems.
A terrific textbook by Kip Viscusi and my Wharton colleague, Joe Harrington, Economics of Regulation and Antitrust, offers an in-depth and valuable treatment of just what its title says. Cass Sunstein’s After the Rights Revolution: Reconceiving the Regulatory State, along with Stephen Breyer’s earlier Regulation and Its Reform, remain excellent introductions to the rationales for regulation and the theory behind different regulatory instruments. (I’m biased, but I believe a recent report from National Academies of Sciences, Engineering and Medicine that I helped write, Designing Safety Regulations for High-Hazard Industries, offers the best guide to thinking about regulatory instrument choice for any domain of regulation.)
When I teach students about how the rulemaking process works in Washington, DC, I have them read David Kessler’s memoir, A Question of Intent: A Great American Battle With A Deadly Industry. It offers a gripping account of what it was like for Kessler, as head of the FDA, to try to bring the tobacco industry under his agency’s regulatory purview. Anyone interested in learning about the work of regulatory inspectors would still be advised to read Eugene Bardach and Robert A. Kagan’s classic, Going by the Book: The Problem of Regulatory Unreasonableness.
And I’d be remiss if I didn’t mention my latest edited volume, Achieving Regulatory Excellence, which is to my knowledge the only book so far to focus squarely on what “quality” means in the regulatory context. I learned a lot from the different perspectives offered by the leading scholars and practitioners from around the world who contributed chapters to this book.
What do you like to do outside of work?
One of the distinctive features of an academic life is that “work” is itself intrinsically rewarding. I’m privileged to do what l thoroughly enjoy: reading, studying, writing and talking about regulation. When I’m not doing those activities, I swim for fitness and enjoy spending time with my family. I have also taken a particular fascination over the years to reading books about high mountaineering expeditions: Jon Krakauer’s Into Thin Air
and Joe Simpson’s Touching the Void
are among the better known examples in this genre. Perhaps my fascination as an armchair mountaineer stems from having grown up in the flatlands of the Chicago suburbs. Or perhaps it is because, even in remote locations in high mountains, mountaineers are a lot like regulators. To succeed, they need great technical skill, good judgment, an ability to work together well as a team, and a capacity for making highly consequential decisions, often under considerable uncertainty.
This article is part two of a two-part series interviewing UPenn Professor and Director of the Penn Program on Regulation Cary Coglianese. Read part one here.