Government Affairs articles

It is time to act on patent reform

Changes will help protect Kentucky’s healthcare innovation sector. By Randy Riggs and Kyle Keeney As lawmakers return to our nation’s capital from the August work period, it’s as good a time as any to think about what lies ahead on the legislative agenda for the remaining months of 2014 and into next year. There are a host of unresolved issues that

Gov. Beshear: State Properties to go Tobacco-Free

Citing Kentucky’s continued worst state ranking in smoking and cancer deaths, Governor Steve Beshear announced today that all executive branch state property campuses will be tobacco-free effective November 20 – the day of the Great American Smokeout. That means no cigarettes, tobacco products or e-cigarettes may be used in state-owned or leased buildings, in state-owned

Kentucky Adult Protective Services Caregiver Misconduct Registry

The Kentucky Department for Community Based Services (DCBS) will launch a new web-based registry that will allow vulnerable adult service providers and individuals, pursuant to Kentucky Revised Statute (KRS) 209.032, to query the Cabinet for Health and Family Services (Cabinet) as to whether a validated substantiated finding of adult abuse, neglect, or exploitation has been

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