June 26 P&P Quick Takes: FDA solicits comments on transparency programs; plus Louisiana’s HCV drug model and more

FDA seeking feedback on clinical data pilot
FDA is seeking feedback on two programs designed to improve clarity and transparency related to drug approval decisions. Under the Clinical Data Summary Report pilot, launched in January 2018, FDA will disclose portions of clinical study reports from up to nine recently approved NDAs. The other program is focused on developing a new integrated review process and template for new drug applications. Comments are due in 60 days (see "Gottlieb Reveals Pilot Program for Clinical Data Transparency").

CMS approves Louisiana’s subscription-based HCV drug model
CMS approved Louisiana’s Medicaid state plan amendment authorizing the state to negotiate supplemental rebate agreements with HCV drug manufacturers and purchase an unlimited amount of HCV drugs for a capped monthly price under a subscription-based model. Earlier this year, the state struck a five-year deal with Gilead Sciences Inc. (NASDAQ:GILD) subsidiary Asegua Therapeutics LLC to provide an authorized generic of Epclusa sofosbuvir/velpatasvir to Louisiana’s Medicaid-enrolled and incarcerated HCV patients. Louisiana Department of Health Secretary Rebekah Gee said the department aims to treat 31,000 people with HCV by 2024 (see “The Louisiana Purchase”)...