Rx-to-OTC switch

YOUR NEEDS

• Make a well-informed go/no-go decision based on an evaluation of a drug’s regulatory and commercial Rx-to-OTC switch potential
• Demonstrate in well-designed consumer studies that consumers can follow the Drug Facts Label and use a drug safely and effectively in the nonprescription setting
• Compellingly address the concerns of FDA and other stakeholders
• Gain regulatory approval and maximize product success

OUR SERVICES

• Assess the feasibility of regulatory and commercial success of a switch based on a comprehensive assessment of the science and the issues likely to be raised by the switch
• Develop and help execute an FDA strategy in support of IND and NDA submissions
• Draft and evaluate OTC Drug Facts Labels, Consumer Information Leaflets, and behavioral support materials
• Plan and help design the overall development program, including label comprehension studies, self-selection studies, actual use trials and tailored consumer studies
• Identify data needs and develop specialized research to support product approval and marketing claims
• Build the benefit/risk case and develop a compelling science-based public health rationale for the switch
• Assist in development of post-marketing commitments

OUR EXPERTISE

• Clinical and Behavioral Research
• Data Management and Statistical Analysis
• Clinical Pharmacology
• Regulatory and Health Policy
• Integrated Strategic Communications

Value to our clients

PinneyAssociates understands that Rx-to-OTC switches are complex initiatives that raise regulatory, scientific/medical, policy and commercial issues involving sometimes conflicting interests of multiple stakeholders. We have over 20 years of experience in providing strategic regulatory insights for OTC switches, direct-to-OTC approvals, and existing OTC products, which enables us to provide comprehensive science-based support to sponsors throughout the product lifecycle.