Guiding clients through the complex and dynamic Rx-to-OTC switch regulatory process
Drawing on over 20 years of Rx-to-OTC switch experience, Lucy specializes in developing and executing science-based regulatory strategies that help our clients to:
- Identify and address the issues raised by switches and meet FDA’s switch requirements
- Develop research-based OTC labeling for switch products
- Design behavioral and other studies to support switches
- Build the individual and public-health focused benefit-risk case for switches
- Prepare for FDA interactions, regulatory submissions, and advisory committee meetings
Lucy recently assumed the role of company President. After joining Pinney Associates in 1998 and directing our issues management team for more than 10 years, Lucy was named Vice President for Program Operations and Rx-to-OTC Switch, and subsequently served as the Pinney Associates Senior Vice President. She has managed projects supporting OTC switch programs, OTC-approved products, prescription medications and vaccines, and nonprofit public health advocacy organizations.
Lucy has supported OTC switch efforts for a wide range of products. They include contraceptives as well as treatments for allergic rhinitis, elevated cholesterol, heartburn, hypertension, infections, insomnia, pain, migraine, and many others.
- Postgraduate work, History of Medicine, Oxford University
- BA with high distinction and high honors, History, University of Michigan