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 compliance matters such as product registrations, Good Manufacturing Practices, clinical trials, advertising and promotion, and Corporate Integrity Agreement compliance. 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 Implementation. Legal lead on CIA implementation working groups including Medical Affairs (including medical science liaisons, compendia and medical information), promotional materials review, non-promotional materials review, and risk assessment and mitigation processes.
- Clinical Trials. Negotiation and drafting of clinical study agreements, subject compensation, recruiting, agency notifications, site audits and inspections, termination of investigators and financial disclosure requirements. Advisor on FDAAA-required clinical trial registration and results reporting requirements.
- 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.
- Pharmacoviligance (PV). Advised on global PV questions, such as safety reporting events, agency interactions and inspections, and safety data exchange agreements.
- 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.
- Quality Compliance. Advised on 483 responses, recalls, field alerts and other product quality issues.
- 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)