Alison Fethke

“I help life sciences companies translate complex legal and regulatory requirements into practical, sustainable programs that enable innovation, reduce risk, and stand up under scrutiny.” —Alison Fethke

When the pressure is on—whether from a Department of Justice (DOJ) or Food and Drug Administration (FDA) inquiry, a board demanding compliance assurance, or a challenging marketing environment—life sciences and health care clients turn to attorney Alison Fethke for guidance that is both legally sophisticated and grounded in business reality.

Alison advises med tech and biopharmaceutical companies on the full spectrum of legal issues related to sales, marketing, medical affairs, and research activities, including federal and state laws and industry codes that govern manufacturers' interactions with health care providers, payors, and patients. She regularly guides life sciences and health care companies through the complex fraud and abuse challenges that arise when structuring sales and marketing arrangements and patient and product support programs. Alison provides strategic counsel on FDA requirements for the testing, sales, and promotion of prescription drugs and medical devices, helping clients structure compliant pathways for product commercialization and lifecycle management. She also counsels clients on the design and implementation of comprehensive compliance programs both domestically and globally.

In addition, Alison supports health care institutions and life sciences companies responding to government investigations, including DOJ and Office of Inspector General inquiries. She provides advice on negotiating and implementing deferred prosecution and corporate integrity agreements (CIAs), including compliance and quality program requirements, independent review organization (IRO) oversight, and reporting obligations.

Alison previously served as Division Counsel, Legal Regulatory & Compliance, at a leading biopharmaceutical company, where she gained firsthand insight into the operational realities and business pressures her clients navigate. Her experience also includes several years as Associate General Counsel for a privately held disease management company, where she focused on client contracting and licensing. Early in her career, she clerked for the Honorable Emilio M. Garza of the U.S. Court of Appeals for the Fifth Circuit.

What Alison Delivers for Clients

• End-to-End CIA Support: Clients facing CIAs benefit from Alison's experience negotiating, implementing, and maintaining compliance with CIA requirements, including effective oversight, structural design, IRO management, and government reporting obligations that protect against further enforcement exposure.
• Proactive Fraud and Abuse Counseling: Alison helps pharmaceutical and medical device manufacturers structure compliant commercial arrangements, including health care provider and patient relationships, discount and rebate programs, patient assistance initiatives, and payor and vendor contracting, applying Anti-Kickback Statute and state law frameworks to enable business growth while managing enforcement risk.
• Actionable Compliance Programs: Drawing on her years of in-house experience, Alison designs and enhances compliance frameworks that integrate policy, training, auditing, monitoring, and risk management—helping clients demonstrate effectiveness to regulators and leadership while supporting commercial and medical objectives.
• Global Compliance Insight: Alison advises on the Foreign Corrupt Practices Act and other anti-corruption laws, third-party due diligence and monitoring, and global health care compliance structures—helping multinational operations keep pace with evolving enforcement expectations.
• FDA Regulatory Strategy: Clients rely on Alison's counsel on drug advertising and promotion issues across all media, labeling requirements, disease awareness campaigns, health economic data communication, and scientific exchange, ensuring promotional and scientific activities align with FDA expectations and industry standards.

• Chambers USA: America’s Leading Lawyers for Business: Illinois—Healthcare (2023 to 2025)
• Illinois Rising Stars, Food & Drug and Healthcare (2005 to 2007 and 2014 to 2015)

Education

• New York University School of Law (J.D., cum laude, 2000)
• Note Development Editor, New York University Law Review
• Duke University (B.A., cum laude, 1997)