OTC Products
Our OTC Products team specializes in Rx-to-OTC switch and supporting marketed consumer healthcare products that enhance people’s lives and public health. We provide strategic advice and tactical support to help you reduce regulatory risk, achieve regulatory approval, secure competitive claims, and enhance the reach and value of your products. With 30 years of experience in supporting OTC switch and OTC products, Pinney Associates has a deep understanding of the dynamic scientific, regulatory, policy, and commercial environment, and we apply that understanding to meet your specific needs and goals.
EXPLORE OUR SERVICES
Rx-to-OTC Switch Strategy & Support
We apply decades of OTC switch experience to help you secure regulatory approval and maximize your product’s reach and commercial success by helping you make informed decisions about whether, and then how, to pursue a switch.
Your OTC switch program needs to be tailored to your goals and constraints, the challenges specific to your switch candidate, and the current regulatory, policy, and commercial environment. Each switch is unique, and tailoring your strategy to your switch is key to FDA approval.
With our distinct approach, we help you identify and then develop compelling science-driven responses to issues raised by FDA and other stakeholders and strategies to manage those issues.
OTC Switch Regulatory Strategy and Support
- Regulatory feasibility assessment
- FDA meeting strategy, planning, support, and participation
- Drug Facts label development and support
- Consumer information leaflet and consumer education material development and support
- Label comprehension, self-selection, actual use, human factors, and tailored consumer studies design
- Issues identification, including regulatory, scientific, and public policy environment assessment
- Issues management, including development of compelling science-driven responses to address issues, and strategies to manage issues
- Stakeholder position audits, engagement strategies, and execution
- Data-driven benefit-risk case and public health rationale development
- Targeted literature reviews and analyses of Federal government survey data
- Data analysis, interpretation, and reporting
- Drug safety support
- NDA preparation (including ISSs, ISEs, and 120-day safety updates)
- FDA advisory committee preparation
Marketed Product and Ingredient Defense
When questions arise about the safety of an approved OTC product or ingredient, we help you assess the body of evidence and develop and execute an evidence-based program to address those questions.
- Short and long-term strategy and planning
- Regulatory, scientific, and public policy environment assessment
- Pharmacology and safety data assessment
- FDA engagement including meeting strategy, preparation, and participation
- Behavioral, including patterns of use, research design
- Data analysis, interpretation, and reporting
- Data-driven benefit-risk case and public health rationale development
- Stakeholder engagement including message development and testing
