print this page

Over-The-Counter Strategic Services

Prescription to over-the-counter (OTC) switches and direct to OTC approvals are complex initiatives that can raise regulatory, scientific, commercial, and policy concerns, and involve the sometimes conflicting interests of multiple stakeholders.  Pinney Associates' experience in supporting prescription to OTC switches, direct to OTC approvals, and existing OTC products enables us to provide comprehensive support throughout the product lifecycle from clinical development, to preparation for regulatory submissions and FDA Advisory Committee meetings, to marketing and post-marketing clinical and regulatory guidance.

Our teams support clients' research and development, commercial, and regulatory functions.  Most importantly, our Issues Management process helps clients to create or amend a Drug Facts label, shape the New Drug Application, prepare for FDA Advisory Committee meetings, and address the concerns of key stakeholders.

Specific services Pinney Associates provides in support of OTC products include:

• Conduct preliminary feasibility assessments, including a review of clinical data and the scientific, medical, and policy environments
  
  
• Identify, assess, and prioritize issues through literature reviews, expert interviews, dataset analyses, and reviews of label development and comprehension testing
  
  
• Develop a comprehensive public health rationale for a drug's OTC availability, including a risk-benefit analysis, and strategic and tactical considerations
  
  
• Develop science-based, data-driven responses and management strategies for scientific, regulatory, and policy issues, including comprehensive reports to facilitate regulatory submissions, regulatory meetings, and FDA Advisory Committee meetings
  
  
• Organize and facilitate expert panel meetings, including the identification and contact of experts in the field
  
  
• Assist and advise in preparations for regulatory submissions, regulatory meetings, and FDA Advisory Committee meetings
  
  
• Evaluate Drug Facts labeling and design label comprehension studies and actual use trials to support OTC switches in coordination with our Clinical and Behavioral Research Team and our Data Management and Analysis Team
  
  
• Identify and analyze datasets, including public use data sets and existing surveys
  
  
• Identify data needs and develop specialized market research and clinical trial designs to support product approvals and marketing claims
  
  
• Develop peer-reviewed publications and presentations for scientific meetings and conferences