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# Stakeholders’ Perspective on Nonprescription Drug Access
- URL: https://www.fdaweb.com/stakeholders-perspective-on-nonprescription-drug-access/
- Published: 2026-02-04T12:00:00.000Z
- Updated: 2026-09-14T15:32:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160605

Responding to an FDA request for information on increasing access to nonprescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it is aligned with the goal of increasing access to nonprescription drugs, Rx to over-the-counter (OTC) switch decisions “must remain rooted in scientific analysis of safety and efficiency and must be made in line with FDA’s charge to promote public health.” The PhRMA comment [letter](https://www.regulations.gov/comment/FDA-2025-N-4731-0044?ref=fdaweb.com) says FDA should:

- work with sponsors to determine whether a drug can be switched from prescription to nonprescription status;
- preserve incentives to switch products; and
- utilize tools provided through the ACNU (additional condition for nonprescription use) final rule to facilitate the availability of over-the-counter products.

In its [response](https://www.regulations.gov/comment/FDA-2025-N-4731-0043?ref=fdaweb.com), the Consumer Healthcare Products Association (CHPA) comments on the general importance of allowing flexibility in regulatory policy, study design, study endpoints, and success thresholds, labeling, and other factors that would allow for marketing approval of safe and effective OTC products. CHPA points out that some prescription medicines that have the potential to be made available OTC involve more complicated selection criteria, more contraindications, more complex dosing, and/or chronic conditions or silent conditions where symptoms are not readily self-recognized. “Such inherent complexities should not prevent these products from switching to OTC status,” it says. “Regulatory flexibility and modernized evidentiary approaches, as well as benefit/risk assessment grounded in real-world (rather than theoretical perfection of) Rx medication use for OTC drug development programs is essential.”

The Association for Accessible Medicines [says](https://www.regulations.gov/comment/FDA-2025-N-4731-0048?ref=fdaweb.com) it “strongly supports FDA’s goal of expanding patient access to safe and effective medicines….” It says that policies intended to increase access to OTC drugs must be carefully designed and implemented to avoid unintended consequences that could actually undermine affordability, reduce insurance coverage, or weaken the robust generic drug marketplace upon which patients rely.