Here’s Looking at You, OTC Drugs: FDA Requests Information to Plan for Public Meeting on Increasing Access to Nonprescription Drugs and Issues New MaPP on OTC Switches and Generics

The first days of December has been marked by an unusual burst of activity related to OTC drugs at FDA.

Request for Information for 2026 Meeting

As previewed by former CDER Director Tidmarsh at the Consumer Healthcare Products Association meeting in September, FDA announced last week its intent to schedule a public meeting in 2026 on increasing access to nonprescription (OTC) drugs. In preparation for the meeting, FDA issued a request for information inviting interested parties and the public (specifically including commercial drug developers, health care providers, and consumers) to share their perspectives on scientific, regulatory, and practical considerations related to nonprescription drug use.

The request includes specific questions for which FDA is seeking input that will be used to inform topics for the 2026 public meeting. The questions listed below are described as being “most pertinent to increasing access to nonprescription drugs.”

1. What are challenges faced in the development of drugs for nonprescription use?
2. What are the biggest opportunities to improve access to nonprescription drugs?
3. How could interested parties— including, but not limited to, drug developers, health care providers, patients, consumers, and retailers— work together to increase access to safe and effective nonprescription drugs?
4. Looking ahead to a 2026 public meeting, what specific topics or questions would you like to see on the agenda for public discussion?
5. What scientific barriers most limit progress in increasing access to nonprescription drugs?
6. What additional scientific tools, technologies, or data sources could support access to nonprescription drugs?
7. Are there specific diseases or conditions that have not, traditionally, been treated with nonprescription drugs for which nonprescription drugs could be safely and effectively used without the supervision of a licensed healthcare practitioner? If so, what information would support such use under the applicable statutory and regulatory requirements for nonprescription drugs?

In the past five-plus years, two programs have been introduced that were designed, at least in part, to increase access to OTC drugs. The first was under OTC Monograph Reform enacted in the 2020 CARES Act which includes a process for adding ingredients or new uses to the monographs through the submission of an OMOR (over-the-counter monograph order request) (read our blog here), and the second was the final rule for ACNU to allow for the approval of an OTC drug with “additional conditions of nonprescription use” beyond the information found in the drug facts label (DFL) (read our blog on ACNU here).  Although the final ACNU rule issued in January 2025 only became effective in May of this year, and the OMOR process was expected to take some time to get up and running, the lack of increase in OTC options under these programs and the generally low numbers of OTC switches in recent years may be a factor the Agency’s decision to hold this meeting.  It will be interesting to see whether commenters provide implementable suggestions for increasing access to nonprescription drugs or primarily describe frustrations with the current programs, and what FDA does with the comments and, eventually, the meeting itself.

The comment period closes on February 2, 2026.

New MaPP for ANDAs of a Switched NDA

This week FDA issued a new Manual of Policies and Procedures (MaPP) for when a reference listed drug (RLD) undergoes an OTC switch from prescription to nonprescription status. MaPP 5200.11, entitled “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” applies only to full Rx-to-OTC switches. The MaPP describes that in this situation, ANDAs referencing the now-switched NDA must update labeling with the relevant changes and that FDA does not consider the full Rx-to-OTC product approved through a supplement to the original Rx NDA to be a different listed drug. Consequently, ANDA holders referencing that NDA can submit a supplement (rather than a new ANDA) to update labeling to reflect the OTC status of the RLD.

The MaPP goes on to set forth timelines for FDA to take certain actions following the switch. Specifically, it provides that FDA will notify the ANDA holders and track whether ANDA holders address the change with the submission of a supplement or withdrawal of the ANDA or other correspondence regarding the intended action and timeline. If no action is taken within six months, a follow-up notification will be sent and if there is no response within 30 days, the Office of Compliance is to be consulted.