The Journal of Law, Medicine & Ethics always strives to be at the forefront of research and policy making. We aim to publish articles that reexamine and expand on the current literature and that create a path forward in medicine, law, ethics, and the many other sub-fields in health and health law. We hope every article we publish contributes to the voluminous literature in a positive way and that our readers are invigorated by the spirited discussion. This supplement issue of JLME continues this multi-disciplinary approach with “Blueprint for Transparency at the U.S. Food and Drug Administration.” Here guest editors Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim and their co-authors have tackled the challenging topic of transparency at the respected government agency. A team of researchers from various universities wrote the main “Blueprint” article of this supplement issue, which is followed by six commentary articles. The Blueprint article recommends 18 specific ways the FDA can be more transparent so that the public at large can be better informed about medical products, applications, and scientific studies. The commentary articles then discuss what may work, the missed opportunities and limitations of the suggestions, and legal approaches and guidelines for the FDA to take. Ultimately, the hope is that the FDA will disclose more throughout its review process, and do so without disrupting trade secrecy protections, in order to improve the public’s health.
In the spirit of disclosure, I offer my own. After ten years as the assistant editor of JLME, I am creating my own path forward and focusing on a new chapter in my life. Working for our parent organization ASLME and editing this journal have been a tremendous professional and personal honor. To our readers, authors, and peer reviewers: thank you for the many years of stimulating conversations and teaching opportunities. To my friends at ASLME: thank you for being the best group of co-workers anyone could ask for. To my editor and mentor Ted Hutchinson: a huge thank you for always believing in me and for your continued support.
Thank you for a great run! I look forward to staying in touch with you.
With best wishes, Courtney