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# FDA to Convene Public Meeting on Expanding OTC Drug Access
- URL: https://www.fdaweb.com/fda-to-convene-public-meeting-on-expanding-otc-drug-access/
- Published: 2026-03-20T12:00:00.000Z
- Updated: 2026-09-14T13:35:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160852

FDA will host a [public meeting ](https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-increasing-access-nonprescription-drugs-04232026?ref=fdaweb.com)next month aimed at exploring ways to expand access to nonprescription, or over-the-counter (OTC), medications, as policymakers and stakeholders continue to examine strategies to reduce healthcare costs and improve treatment availability. The meeting, titled “Increasing Access to Nonprescription Drugs,” is scheduled for 4/23 at the National Press Club in Washington, D.C.

The meeting is part of FDA commissioner **Marty Makary**’s push to encourage moving more medications from prescription-only status to OTC availability. Makary has argued that most widely used drugs already meet basic safety standards and questioned why patients must still obtain prescriptions for many of them. While physicians would retain the ability to prescribe medications that are also sold over the counter, he said the existing system has failed in several areas, citing the overprescribing of opioids and antibiotics as examples.

Makary said FDA plans to formalize clear criteria for determining which drugs are appropriate for nonprescription use. Those standards would focus on medications with strong safety profiles, low or no abuse potential, no requirement for routine laboratory monitoring, and limited risk of misuse. Among the drugs he cited as potential candidates for broader over-the-counter availability was naloxone, commonly known by the brand name Narcan, as well as certain anti-nausea medications.

The over-the-counter drug push was codified late last year in a spending bill ([H.R. 5371](https://www.congress.gov/bill/119th-congress/house-bill/5371?ref=fdaweb.com)) that included the “Over-the-Counter Monograph Drug User Fee Amendments,” which reauthorized FDA’s OTC monograph user fee program and included provisions that pertain to prescription to OTC drug switches (see Hogan Lovells [summary](https://www.hoganlovells.com/en/publications/fda-to-publish-guidance-to-improve-the-rx?ref=fdaweb.com)).

The law further requires FDA to issue a guidance “to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section, including in the case of applications for an Rx-to-nonprescription switch, especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use.” In addition, FDA must – by November – further develop a plan “to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates” for an OTC switch.

According to an agency notice, the upcoming meeting will bring together a range of stakeholders — including drug developers, healthcare professionals, and consumers — to discuss practical considerations for broadening access to OTC therapies. Discussions will center on identifying diseases or conditions that could be safely managed with nonprescription drugs but currently lack OTC options. Participants will also examine the challenges pharmaceutical companies face in developing such products, as well as opportunities to enhance access and foster collaboration among industry and public health stakeholders.

The meeting also builds on a request for information issued in 12/2025\. Responding to the request, Pharmaceutical Research and Manufacturers of America (PhRMA) said that while it is aligned with the goal of increasing access to nonprescription drugs, Rx to 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) said 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) commented 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 pointed 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 said. “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.”