Federal articles

New Law to Address Concerns in 340b Program

By John Hayden More than 25 years ago, Congress enacted the 340B drug discount program with bipartisan support. The 340B program gives hospitals and clinics that largely serve uninsured and low-income patients steep discounts for their medications. However, recent evidence demonstrates that some bad actors are taking advantage of the 340B program for their own

A Balancing Act: Pending Legislation Seeks to Improve Prescription Drug Access While Curbing Abuse

By Susan Bizzell and Nicholas Gonzales Executive Summary On July 29, 2014, legislation designed to both combat prescription drug abuse and ensure patient access to prescription drugs advanced by voice vote in the House of Representatives. This legislation, bolstered by bipartisan sponsorship from Reps. Marsha Blackburn (R-Tenn.), Judy Chu (D-Calif.), Tom Marino (R-Pa.) and Peter Welch

FDA Publishes Compounding Guidance, but Where Are the Regulations?

By Susan Bizzell and Nicholas Gonzales Executive Summary The Food and Drug Administration (“FDA”) released five regulatory and guidance documents pertaining to compounding in an effort to provide clarity to pharmaceutical stakeholders.  The documents, issued pursuant to the Drug Quality and Security Act (“Act”), describe expectations regarding compliance with current good manufacturing practices (“cGMPs”) for compounding

Kentucky Life Science Council Recognizes Sen. Mitch McConnell with Inaugural Life Science Champion Award

The Kentucky Life Sciences Council (KLSC) is pleased to announce the first of several recipients of its inaugural Kentucky Life Science Champion Awards.  Sen. Mitch McConnell is being honored for his steadfast leadership in promoting innovation in the life science sector and for protecting and strengthening Kentucky seniors’ access to the popular Medicare Part D

Advocacy Groups Call for Reduction in Barriers to Care

Three-hundred-and-thirty-three patient groups from around the country, including three from Kentucky, have signed onto a letter to Secretary of Health and Human Services (HHS) Sylvia Mathews Burwell calling for immediate measures to reduce barriers to care for patients who have purchased policies through the Health Insurance Marketplace (the “exchanges”). The letter comes as some patients with chronic