Bethany is nationally recognized for her experience and insight on regulatory matters and advises life science businesses on both pre- and post-market issues, including everything from FDA submissions and communications strategies to post-approval compliance and reimbursement. Bethany regularly helps international and US companies enter and navigate the US health care market. She’s adept at helping clients identify technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment by maximizing health care reimbursement opportunities.
Bethany is Chair of the firm’s FDA practice and leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic life science and health technology companies enter and navigate the US health care market. Bethany helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges affecting everything from product approvals and product labeling to collaborative research, supply, and distribution agreements. She focuses on mission critical strategic engagements, including all aspects of FDA communications. Her client engagements regularly span the full scope of pre-market and post-market issues, from devising unique regulatory strategies that are then implemented through FDA submissions and complex interactions with the FDA, including post-approval compliance and enforcement. Bethany’s representative clients include medical device, drug, combination product, diagnostic, biologic and regenerative medicine, cosmetic, dietary supplement and food industry companies and the investor groups focusing on these industries.
Through her extensive representation of health care provider businesses, she has developed an understanding of compliance issues and of the US health care reimbursement system that far surpasses that of most FDA lawyers. She uses her strengths in these areas to provide clients with insight on regulatory policy, reimbursement issues, and pricing to shape innovation, and helps them use that knowledge to develop viable value propositions within the constraints of the evolving health care delivery system. She advises clients on laws applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues as well as on the ins and outs of government and third-party reimbursement. Clients rely on Bethany’s practical guidance to help them invest and collaborate strategically, by identifying technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment.
Before joining Mintz, Bethany served as the co-leader of the FDA and medical technology services team in the New York office of another law firm. She works with academic centers to educate future business leaders on relevant health care regulatory issues, is frequently invited to speak on issues concerning FDA regulations, health care reimbursement, and pricing and is herself an angel investor