OTC Products

The Pinney Associates 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 commercial value of your products. With more than 25 years of experience in OTC switch and OTC products and brands, 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.

Pinney Associates Lucy Owen, Senior Vice President, John Pinney, Founder and CEO, and Joe Gitchell, President discuss strategy in a contemporary conference room.


Rx-to-OTC Switch Strategy & Support

We apply decades of OTC switch experience to help you secure regulatory approval and maximize your product’s commercial success by helping you make informed decisions about whether, and then how, to pursue a switch. 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

OTC Switch Commercial Assessment and Support

  • Opportunity assessment
  • Competitive landscape analysis
  • Forecast modeling
  • Volume validation testing
  • Brand positioning development
  • Claim identification and validation support testing
  • Concept development and optimization
  • Lifecycle management planning
  • P&L, cost of good, and pricing support
  • War gaming leadership

Rx-to-OTC Switch Project Management

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. We help you develop and manage a tailored switch program that will achieve your regulatory and commercial goals.

  • Program risk/reward assessment
  • Budget planning
  • Project timeline development
  • Project team management
  • Management status reporting

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

Marketing Services

When you are looking for brand-growth opportunities, our veteran marketing specialists help you maximize opportunities via segmentation, positioning, concept development, and life-cycle management support. We can provide seasoned advice as well as turnkey solutions to incremental brand revenue and profit.

  • Claim development and claim-support study development
  • Consumer targeting segmentation, positioning strategies, and concept development
  • Consumer validation research and analysis
  • Lifecycle management support
  • War gaming leadership

Business Development Services

When you seek strategic growth opportunities via existing product assets, new technologies, or a potential Rx-to-OTC switch, we help you identify and assess new opportunities. Our experts have extensive, hands-on business development experience with major and mid-tier consumer healthcare companies. We help you evaluate and optimize your acquisition of strategic assets with appropriate due diligence and senior guidance.

  • Due diligence planning and execution
  • Integration planning and management
  • Opportunity and risk assessments
  • OTC forecast modeling and validation research
  • Project timelines and management
  • Transactional support with potential partners

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