Anti Kickback Regeneron Faces False Claims Act Suit Thomas Sullivan Aug 17, 2020 0 Earlier this summer, the United States Attorney’s Office for the District of Massachusetts filed a lawsuit against Regeneron…
Open Payments Open Payments Data Analysis & Compliance Effectiveness Go Hand-in-Hand Thomas Sullivan Aug 14, 2020 0 Dr. Seth B. Whitelaw, Editor for the Policy & Medicine Compliance Update (1) As Summer 2020 begins winding down, we are now…
Anti Kickback Dismissal in Trinity Qui Tam Suit Affirmed Thomas Sullivan Aug 13, 2020 0 In June 2020, the United States Court of Appeals for the Eighth Circuit affirmed the dismissal with prejudice of a qui tam suit…
Congress E&C Subcommittee on Health Holds Hearing on Health Care Inequality Thomas Sullivan Aug 12, 2020 0 On June 17, 2020, the Health Subcommittee of the United States House of Representatives’ Committee on Energy and Commerce held a…
FDA OPDP Enforcement Slowing to a Crawl? Thomas Sullivan Aug 11, 2020 0 We have previously written about the downward slope of enforcement letters from the United States Food and Drug Administration…
FDA FDA Proposes New Right to Try Requirements Including Annual Reports from… Thomas Sullivan Aug 10, 2020 0 In a recently proposed rule, the FDA proposed Right to Try law requirements. The agency will require drug manufacturers to issue…
COVID-19 DOJ Will Allow Monoclonal Antibody Manufacturers to Share Information in… Thomas Sullivan Aug 7, 2020 0 The United States Department of Justice recently announced that it does not plan to challenge proposed efforts by a handful of…
CMS CMS to Revamp the Medicaid Drug Rebate Program: To Encompass Value Based… Thomas Sullivan Aug 6, 2020 0 Recently, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would materially modify current…
DTC Federal Trade Commission (FTC) Annual Report: Sets Their Sites on Life… Thomas Sullivan Aug 5, 2020 0 The Federal Trade Commission (“FTC”) recently released its annual report for 2019. The FTC’s annual report details the FTC’s…
FDA FDA Abandons DRD Proposal Thomas Sullivan Aug 4, 2020 0 Earlier this year, the United States Food and Drug Administration (FDA) announced it would no longer pursue a proposed regulatory…