Alison Fethke is 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 advises 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.
Alison also serves as a Steering Committee member of R&G Insights Lab, a differentiated solution for corporate governance and risk in complex business environments.
Experience
- CIA Advice. Provide advice with respect to negotiation, implementation and adherence to Corporate Integrity Agreements, including compliance and quality program requirements, IRO oversight, and reporting obligations.
- Fraud & Abuse. Provide advice on Federal and state Anti-Kickback laws, including HCP arrangements, commercial contracting, discounts and promotions, and patient support programs.
- Compliance Program Development. Regularly advise on compliance program development and sustainability for health care providers and life sciences companies, including policy development, training, risk assessments, auditing and monitoring, and internal investigations.
- Global Health Care Compliance. Co-lead of the firm working group dedicated to global compliance matters for health care entities, advising on compliance program structure, operations and mandate, FCPA and other anti-corruption laws, and diligence and monitoring processes for third parties.
- Drug Advertising and Promotion Issues. Advised on all aspects of drug promotion and communication, including advertising (all media), labeling, disease awareness, health economic data and scientific exchange.