A Patient-Centric Approach to Reforming the Prescription to Over-the-Counter Drug Pathway

AWHP recently submitted comments to a Request for Information from the U.S. Food and Drug Administration (FDA) asking the public to share their perspectives on how to increase access to nonprescription drugs. The FDA intends to use the feedback to inform their plans for a public meeting planned for later in 2026. 

In its comments, AWHP highlights the critical role that nonprescription, over-the-counter (OTC) drugs play in supporting the health of Americans nationwide. Expanding access to safe and effective OTC options can enable women, in particular, to address common health needs earlier, more conveniently, and at lower cost. The most direct way to expand access to OTC drugs is to ensure that appropriate, safe therapies can move efficiently from prescription-only status to nonprescription, OTC availability. However, the current prescription-to-OTC switch process has not kept pace with today’s healthcare needs and must become more transparent, predictable, and responsive to patients. 

Read AWHP’s full comments here.

These comments build on insights from a recent roundtable discussion convened by AWHP in collaboration with the Alliance for Aging Research. The discussion brought together 16 diverse patient organizations to examine barriers and opportunities within the prescription-to-OTC pathway. Together, participants identified several key themes, including: 

  • Opportunities to build on the FDA’s current prescription to nonprescription drug process 
  • The need for improved education for patients, providers, and caregivers 
  • The importance of amplifying patient voices in the switch process 
  • Chances for greater collaboration among stakeholders 
  • The need for a roadmap that outlines challenges and envisions a more efficient path forward 

The roundtable’s key recommendations to policymakers, healthcare leaders, and industry stakeholders are summarized in a white paper, available here.

Thanks for your interest in AWHP. Please fill out the form below and we will be in touch soon.

    X