Successful Rx to OTC Switch Depends on Responsiveness to FDA and Other Stakeholder Issues of Concern, Early and Integrated Commercial Planning

Categories: FDA, Rx-to-OTC Switch

Christine Sweeney and George Quesnelle

FDA approval of an Rx-to-OTC switch depend on anticipation of issues likely to be raised by FDA division and nonprescription staff, as well as other policy stakeholders.  Commercial success following approval similarly requires addressing issues even before submission and looking beyond FDA approval.

“Rx-to-OTC switch is not a regulatory check-box exercise, it’s a policy change, supported by argument and data.” – Christine Sweeney

In a two-part webinar (recording available at the links below until February 2019), we discussed the importance of:

  • Thoughtful selection of switch candidates through regulatory and commercial feasibility assessments
  • Early development of FDA strategy, taking into consideration development of a sound Drug Facts Label and other consumer information materials, as well as well-designed consumer studies. These studies include label comprehension, self-selection and, if needed, behavioral (actual use) data to demonstrate the drug can be used safely and effectively in the nonprescription setting
  • Identifying and addressing concerns of FDA and other key stakeholders with science-based, data-driven responses
  • Building a compelling benefit/risk case for the switch
  • Strong leadership and project management linking regulatory, clinical, medical and commercial strategies and workstreams
  • Sound preliminary forecasts requiring consumer behavior insights

“A successful Rx-to-OTC switch process looks beyond FDA approval to encompass the pathway for commercial success.” – George Quesnelle

To access our two-part webinar series on Rx-to-OTC Switch, click here:

Part 1 of 2: Planning for Regulatory Success

Part 2 of 2: Rx-to-OTC Switch: Planning for Commercial Success