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?
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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
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