Publication Date: 2021-06-30
Practice Area: Health Care Law
Industry: Federal Government | Pharmaceuticals
Court: U.S. District Court of Delaware
Judge: District Judge Stark
Attorneys: For plaintiff: Michael P. Kelly, Daniel M. Silver, Alexandra M. Joyce, McCarter & English, LLP, Wilmington, DE; Allon Kedem, Jeffrey L. Handwerker, Sally L. Pei, Stephen K. Wirth, Arnold & Porter Kay Scholer LLP, Washington, DC for plaintiff.
for defendant: Brian D. Netter, Michelle R. Bennett, Rachael L. Westmoreland, Kate Talmor, Jody Lowenstein, U.S. Department of Justice, Washington, DC for defendants.
Case Number: D69446
U.S. Department of Health and Human Service's guidance regarding the 340B drug program violated the Administrative Procedure Act due to lack of notice-and-comment where guidance materially altered obligations of drugmakers under the 340B program and constituted a final agency decision.