Increasing Access to Nonprescription Drugs

Why It Matters

Expanding OTC drug options can lower treatment costs, increase patient self‑management, and reshape pharma pipelines, making regulatory clarity critical for industry and public health.

Key Takeaways

• FDA explores new pathways to expand OTC drug availability.
• Direct-to-OTC, prescription-to-OTC switch, and added‑condition applications are outlined.
• Safety, labeling, and consumer‑study data required for OTC approval.
• Over 100,000 OTC ingredients exist; US leads globally but seeks more.
• Stakeholder input sought to improve self‑care, access, and public health.

Summary

The Duke Margolis Institute for Health Policy and the U.S. Food and Drug Administration convened a stakeholder meeting to discuss expanding access to non‑prescription (OTC) medicines through a new drug‑application framework.

FDA officials outlined three pathways—direct‑to‑OTC submissions, prescription‑to‑OTC switches, and applications that add specific conditions for OTC use. They emphasized that approval hinges on a wide safety margin, low abuse potential, and consumer‑friendly labeling supported by rigorous consumer‑behavior studies. Recent policy signals, including a 2025 executive order and an FDA request for information, are driving the push for more OTC options.

Acting Director Karen Murray reminded participants that the 1951 Humphrey Amendment created the prescription versus non‑prescription dichotomy, making OTC the default class. She illustrated the labeling challenge by contrasting a full prescribing information sheet with the concise Drug Facts Label, and explained the distinction between full and partial prescription‑to‑OTC switches.

If the FDA adopts these pathways, pharmaceutical firms could bring a broader range of self‑care products to market, potentially reducing healthcare costs and expanding consumer autonomy. However, the requirement for robust safety and labeling data means sponsors must invest in consumer‑centric research, reshaping product development and market strategy.

Original Description

This public meeting, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the U.S. Food and Drug Administration, convenes drug developers, health care providers, patient and consumer representatives, and other relevant stakeholders to discuss opportunities to increase access to nonprescription drugs. The meeting focuses on the new drug application process for nonprescription drugs, which includes direct-to-nonprescription applications, prescription-to-nonprescription “switch” applications, and applications with Additional Conditions for Nonprescription Use. Participants also discussed practical considerations related to access, innovative strategies to increase access, and how increased access may affect individual and public health outcomes.