Alison Fethke is a counsel in the health care group of Ropes & Gray. Alison brings to clients her experience managing complex legal and regulatory matters in the health care and life sciences industries. She provides regulatory advice on a wide range of issues, including health care and FDA regulatory matters and compliance program development and support.
Alison regularly advices medical device and pharmaceutical companies on legal issues related to sales, marketing, medical and research activities, including federal and state laws and industry codes regulating manufacturer interactions with providers, payors and patients. In addition, Alison provides advice with respect to FDA requirements related to the testing, sales and promotion of prescription drugs and medical devices.
Alison works with health care institutions and life sciences companies to implement and enhance comprehensive compliance programs both domestically and globally, including structural design, operational support, and external assessments of program effectiveness. Alison also advises health care and life sciences clients with respect to government investigations, and has assisted with the negotiation and implementation of multiple Corporate Integrity Agreements.
Before joining Ropes & Gray, Alison was Division Counsel, Legal Regulatory & Compliance at Abbvie, Inc., the pharmaceutical company resulting from the separation of the Abbott Laboratories in 2012. Alison’s experience also includes several years of being Associate General Counsel for a privately-held disease management company, focusing on client contracting and licensing.