Alison Fethke

Member at Epstein Becker Green

Speaker

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