K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more
Why It Matters - This decision casts doubt on the ability of nursing homes to rely on the PREP Act to shield them from liability against state-law claims or, at the very least, to remove such claims to federal court....more
On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more
This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would...more
EPA Issues First Year Implementation Plan - On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law. This law amends the Toxic Substance Control Act (TSCA) and is the first...more