Overview
On April 7, two federal courts issued conflicting rulings concerning FDA approval of mifepristone. The holding in Alliance for Hippocratic Medicine v. FDA resulted in a preliminary injunction that imposes a nationwide “stay” of FDA’s approval of this drug. Washington v. FDA, however, resulted in a preliminary injunction enjoining FDA from suspending access to the drug in 17 states and the District of Columbia. DOJ has appealed to the Supreme Court to restore full access to this drug and the SCOTUS decision is imminent. How will these judicial decisions affect the medical community and patients? What are FDA’s options in responding to these two conflicting cases? What are the broader implications for FDA and drug manufacturers around product approvals?
Get Access
- +$100 for nonmembers
Speakers
Kelly F. Goldberg, Vice President, Law/ Senior Counsel for Biopharmaceutical Regulation, PhRMA
Lewis A. Grossman, Professor of Law, American University
Jordan K. Paradise, Georgia Reithal Professor of Law, Loyola University – Chicago
Eva Temkin, Partner, King & Spalding LLP
Moderated by Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett
KELLY F. GOLDBERG is Vice President, Law and Senior Counsel for Biopharmaceutical Regulation at Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Goldberg joined PhRMA in 2017. Since then, Ms. Goldberg has led the legal function for the U.S. Food and Drug Administration (FDA) and related regulatory law issues, providing primary legal support on all manner of FDA and related legislative, regulatory, advocacy, and policy issues. Recently, Ms. Goldberg served as the biopharmaceutical industry legal negotiator for The Prescription Drug User Fee Act VII and oversaw PhRMA’s legal support for the Biosimilar User Fee Amendments III negotiations. Prior to joining PhRMA, Ms. Goldberg spent over a decade at Pfizer in Regulatory Law. Ms. Goldberg was an associate in the Food and Drug practice group at Covington & Burling before joining Pfizer. She earned her JD, cum laude, from the University of Pennsylvania Law School and clerked for the Honorable Joseph E. Irenas on the United States District Court for the District of New Jersey. She is a member of the bar in New York and the District of Columbia. Ms. Goldberg received her Bachelor of Arts in History from the University of Virginia.
LEWIS A. GROSSMAN, is Professor of Law and Affiliate Professor of History at American University. He has also been a Law and Public Affairs Fellow at Princeton University and a Visiting Professor at Cornell Law School. He teaches and writes in the areas of food and drug law, health law, American legal history, and civil procedure. Prior to joining the American University faculty, Professor Grossman was an associate at Covington & Burling LLP (where he currently serves as Of Counsel), and before that he clerked for Chief Judge Abner Mikva of the US Court of Appeals for the DC Circuit. His scholarship has appeared in numerous academic journals and published volumes. In October 2021, Oxford University Press published Professor Grossman’s book, Choose Your Medicine: Freedom of Therapeutic Choice in America. He is also the co-author (with Peter Barton Hutt) of Food and Drug Law: Cases and Materials. He has served on four committees of the Health and Medicine Division (formerly the Institute of Medicine) of the National Academies of Sciences, Engineering, and Medicine. He is also a former member of the FDLI board of directors. Professor Grossman earned his PhD in History from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a JD from Harvard Law School and a BA from Yale University.
EVA A. TEMKIN is a partner in the King & Spalding U.S. Food and Drug Administration (FDA) and Life Sciences practice where she provides strategic counsel to clients on a wide variety of FDA regulated products, ranging from biosimilars to cell and gene therapies and complex combination products. Temkin advises pharmaceutical and biotechnology companies at every stage of product development and life-cycle, from data generation (including clinical investigations and real-world evidence) to application submissions, exclusivity matters, and dispute resolution. Before joining King & Spalding, Eva acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars, where she oversaw regulatory policy related to biosimilars and other therapeutic biologics. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to FDA’s biomedical product centers on a wide range of drug, biologic, and combination product issues.
VANESSA K. BURROWS is Counsel in Simpson Thacher & Bartlett’s Washington, DC office. She has advised pharmaceutical, medical device, dietary supplement, and tobacco manufacturers in connection with regulatory and compliance needs, as well as M&A and capital-raising transactions. Before entering private practice, Vanessa held several government positions focused on FDA matters, healthcare regulation, and public health. She served as the HIPAA Privacy Officer for the City of Chicago and Attorney for the Chicago Department of Public Health, where she addressed issues including medical countermeasures, emergency preparedness, and quarantine and isolation. Earlier, she advised Members of Congress and their staff on FDA legislation and issues as a Legislative Attorney with the Congressional Research Service. Vanessa handled FDA, healthcare, administrative law and constitutional law matters during the creation and passage of the Patient Protection and Affordable Care Act (ACA), the Family Smoking Prevention and Tobacco Control Act, FDA user fee laws, and the 2009 H1N1 pandemic.Virtual Learning FAQ
Related Content
