Practice Areas

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.

Our OTC Strategic Services team:

• Conducts preliminary feasibility and issues assessments, based on clinical data, the scientific, medical, and policy environments, literature reviews, expert interviews, and analyses of public use and proprietary datasets
• Develops a comprehensive public health rationale for a drug's OTC availability
• Develops science-based, data-driven responses and management strategies for scientific, regulatory, and policy issues
• Organizes and facilitates expert panel meetings, including the identification and contact of experts in the field
• Advises on preparations for regulatory submissions, regulatory meetings, and FDA Advisory Committee meetings
• Evaluates Drug Facts labeling and design label comprehension studies and actual use trials to support OTC switches
• Identifies data needs and develops specialized market research and clinical trial designs to support product approvals and marketing claims
• Develops peer-reviewed publications and presentations for scientific meetings and conferences