In September, Professor Erika Lietzen presented a work in progress at BYU’s law school. The presentation was called “Accountability By Petition.” She will be submitting the paper – now called “The Power of Petitions” – in the February cycle. The paper explores the role that petitions to federal agencies can play in helping us hold agencies accountable, and it is based in part on a review of several thousand petitions that FDA has received since the mid 1970s.
On Nov. 3, Prof. Lietzen moderated a panel on the Food & Drug Law Journal‘s symposium (agenda is here). The panel topic was “Our Bodies, Our Cells: When Courts and Regulators Collide,” and she discussed a work in progress on FDA’s enforcement activities relating to stem cell therapy, by Professor Mary Ann Chirba of Boston College.
On Nov. 14, Prof. Lietzen delivered a report to the Administrative Conference of the United States (ACUS) on user fees assessed by federal agencies. The report can be found here. The report describes the history of user fees, how they are accounted for in the federal budgeting process, and constitutional issues that have been litigated. It also describes user fee design and implementation across a wide range of federal agencies — identifying design decisions that must be made and the choices available; identifying practical and legal constraints on the choices available; exploring the relationship between these choices and core values of administrative law, as applicable; and explaining how program designers might make these choices, both as a procedural matter and as a substantive matter. And it offered a series of recommendations for agencies and lawmakers in Congress, relating to user fee design and implementation. After review and discussion of the report and issues in committee, on Dec.14, ACUS adopted a final recommendation (2023-8) (here) on the objectives, design, and implementation of user fee programs.
In December, at the invitation of the National Academies of Sciences, Engineering, and Medicine, Prof. Lietzen was a panelist during a two-day workshop entitled “Adult Attention-Deficit/Hyperactivity Disorder: Diagnosis,Treatment, and Implications for Drug Development.” (Details about the workshop can be found here.) She spoke on a panel that focused in part on use of regulatory policy to reduce the risk of misuse and diversion, as well as risk of toxicity, and in part on regulatory policy options to encourage or facilitate the development of new medicines for adult ADHD that have less risk. The video of our panel is on the NAS website.