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

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

Specific services Pinney Associates can provide in support of OTC products include:

• Conduct preliminary feasibility assessments, including a review of clinical data, and the scientific, medical, and policy environments
   
• Identify, define, 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 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
   
• Identify and assess circumstances where non-compliance with the label might occur and assess the likelihood and impact of such use
   
• 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
   
• Identify, evaluate, and analyze datasets, including public use data sets and existing surveys
   
• Identify data needs and develop specialized surveys and clinical trial designs to support product approvals and marketing claims
   
• Develop manuscripts for peer-review publication