OVER-THE-COUNTER

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

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.