74 Am. U. L. Rev. 107 (2024).
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Abstract
The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is available about the individual decisions. This undermines the rule of law. This Article describes an administrative mechanism that can help restore the rule of law. That mechanism is a petitioning procedure, and this suggestion is based on studying decades of petitioning at the one federal agency with a formal procedure for accepting and considering any type of petition from any interested party—the Food and Drug Administration. If an agency faces a meaningful threat of judicial review in litigation brought by a petitioner, a petition can prompt it to articulate and explain its statutory interpretations and regulatory policies publicly, rather than simply implementing and illustrating policy as it makes case-by-case decisions. A petition backed by the meaningful threat of judicial review can also force an agency to comply with a statutory mandate or correct errors in law or fact. In short, petitions—some petitions, that is—can increase transparency and through it contribute to the accountability of the administrative state.
* Timothy J. Heinsz Professor of Law and William H. Pittman Professor of Law, University of Missouri School of Law. This project was made possible by a research leave from the University of Missouri School of Law and by summertime financial support through the Charles A. Blackmar Faculty Research Fellowship, Charles H. Rehm Faculty Research Fellowship, Webb R. Gilmore Faculty Research Fellowship, and Henry Lowe Faculty Research Fellowship. I am deeply grateful to Peter Hutt, FDA’s Chief Counsel from 1971 to 1975 and the architect of FDA’s petitioning mechanism, for several hours of conversation about this Article. Portions of this Article undoubtedly also reflect many other conversations we have had over the last nearly 30 years, as well as almost two decades of practicing FDA law with not only Peter but also his successor at the Agency, Richard Merrill (Chief Counsel from 1976 to 1978). This Article also benefitted from discussion at a work-in-progress meeting at Brigham Young University’s J. Reuben Clark Law School and from the questions and comments of Kif Augustine-Adams, Elysa Dishman, John Fee, Cliff Fleming, Brook Gotberg, Cree Jones, Thomas Lambert, Gary Lawson, Haley Proctor, Dane Thorley, and Lucy Williams. Special thanks are also due to Michael Moedritzer (Class of 2024), Kristen Pryde (2023), Avery Welker (2023), and especially Tate Cooper (2023) for research assistance as well as to Cindy Shearrer (Associate Law Librarian for Patron Services) for research support and the staff of the Food and Drug Administration’s Dockets Branch for their assistance.