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.
- 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.
- Regulatory Strategy. Advised on content and timing of regulatory interactions, including submissions, responses and general correspondence, complete response letters, CMC and labeling submissions; requests for safety information, and regulatory (non-patent) exclusivity.
- Co-author, “Emerging Enforcement Trends For Patient Support Programs,” Law360 (May 15, 2018)
- Co-author, “Risky business for pharma,” Pharmaceutical Market Europe (February 8, 2018)
- Quoted, “China, Brazil and Russia named by healthcare companies as the riskiest markets for compliance and regulation,” International Pharmaceutical Industry (October 23, 2017)
- Co-author, "How Conduct Abroad Impacts Health Care Business In US," Law360 (October 12, 2017)
- Co-author, “Value-Based Challenges And Opportunities For Pharma Cos.,” Law360 (July 12, 2017)
- Featured, “Helping piece together the life sciences puzzle,” Chicago Daily Law Bulletin (April 3, 2017)
- Co-author, “Unknowing company executives held responsible for FDCA violations,” Inside Counsel (August 7, 2013)
- Speaker, “Current Areas of Concern for Life Science Corporations: Foreign Corrupt Practices Act,” 3rd Annual Life Science Compliance Training Conference (June 6-7, 2018)
- Speaker, “Mini Summit XIII: Global Compliance in the Transactional Context: Due Diligence, Integration and Post-Transaction Steps,” 18th Annual Pharmaceutical and Medical Device Compliance Congress (November 6-8, 2017)
- Speaker, “Mini Summit VI: Compliance Considerations in Patient Support Programs,” 15th Annual Pharmaceutical Regulatory and Compliance Congress (November 3-5, 2014)