The Alliance responded to a Request for Information from the U.S. Food and Drug Administration, asking the public to share their perspectives on how to increase access to nonprescription drugs. The FDA intends to use the information to inform their plans for a public meeting to be held later in 2026.

In September 2025, the Alliance co-hosted a roundtable with the Alliance for Women’s Health and Prevention (AWHP) that explored patient-centered recommendations to increase access to nonprescription drugs and modernize the Rx to OTC switch process. This white paper was shared in the RFI response, along with the below comment:

“On behalf of the Alliance for Aging Research (the Alliance), we appreciate the opportunity to respond to the Food and Drug Administration’s Request for Information (RFI) on Increasing Access to Nonprescription Drugs (Docket No. FDA-2025-N-4731). The Alliance applauds the administration and FDA for prioritizing policies that expand safe and appropriate access to effective therapies and for recognizing the role that nonprescription drugs play in keeping America healthy.

Increasing access to nonprescription drugs depends not only on which products are available OTC, but also on whether the pathway to nonprescription status is modern, transparent, and predictable. Today, the pathway to switch prescription drugs to nonprescription status remains one of the most direct pathways to expand patient access for conditions that can be self-recognized and self-managed. Yet, it has been immensely underutilized, and, as a result, the pace of switches has slowed over the past decade.

As Americans enter a new age of embracing self-care and having greater autonomy over their health, now is the time to modernize this process in a way that both maintains strong safety standards and also reflects real-world patient needs. This is particularly important for older adults and caregivers, who often face transportation, scheduling, and cost barriers that can make obtaining timely access to prescription care difficult — even for conditions that can be managed safely and effectively with clear labeling, education, and apt safeguards.

The Alliance respectfully submits the enclosed white paper, “Empowering Consumers, Reducing Costs, Improving Health: Reforming the Prescription to Over-the-Counter Drug Pathway – A Patient Centric Approach,” developed in partnership with the Alliance for Women’s Health and Prevention in September 2025. This paper reflects insights from a roundtable of 16 patient organizations and offers patient-centered recommendations that directly support the FDA’s goal of increasing access to nonprescription drugs. Key themes include:

• Increasing transparency and predictability in FDA’s switch process and decision-making;
• Integrating patient perspectives into the development, review, and evaluation of switch candidates;
• Leveraging appropriate use of modern tools as encouraged by the Additional Condition for Nonprescription Use (ACNU) framework to support safe self-selection and use; and
• Improving education for consumers, caregivers, and healthcare providers to promote safe and effective use.

Thank you for your attention to this matter. We look forward to seeing the public meeting come together later this year; the Alliance stands ready to be a resource to the FDA as it evaluates strategies to increase nonprescription drug access to keep America healthy.”