FDA to publish guidance to improve the Rx to OTC switch application process

In the past few decades, FDA has discussed wanting more Rx drugs to be available OTC for several reasons, such as easier accessibility (e.g., going to a local pharmacy instead of needing to see a doctor), lowering health care and other costs (e.g., not having to take time off work to go see a doctor and then head to a pharmacy), and improving patient compliance leading to better health (e.g., keeping patients on medications who do not go to their doctor to get refills). Now, Commissioner Makary is taking up the mantle, posting on X last week that the US “need[s] more drugs to be ‘over-the-counter’” and stating that “FDA will be cutting red tape to deliver more safe and affordable OTC drugs!” Congress is seconding the push for more nonprescription availability.

New legislation regarding OTC switches

The Congressional stopgap spending bill (H.R. 5371) that was signed into law on November 12, 2025, includes the “Over-the-Counter Monograph Drug User Fee Amendments,” which reauthorize FDA’s OTC monograph user fee program for five years (OMUFA II), and also specifically includes, in section 6507, provisions that pertain to prescription to OTC switches. There are three types of approvals that fall within the new law’s definition of an “Rx-to-nonprescription switch”:

• a full switch where the nonprescription drug is approved for use under the same conditions of the prescription drug;
• a full switch where the nonprescription drug is approved for nonprescription use subject to one or more additional conditions for nonprescription use (ACNU) (for more about the ACNU final rule, see our prior alert); and
• a partial switch, under which the drug is approved for nonprescription use only under certain conditions described in the approved labeling, while the drug otherwise remains approved for prescription use only

FDA meetings

The language specifies that when planning to submit a New Drug Application (NDA) for an Rx to OTC switch, the applicant may submit a written request to FDA for a meeting to develop a plan for such an application. The purpose of the plan is to address “the potential risks to public health of such switch and the evidence necessary to support such application, including the design of any necessary studies, and the format and content of the planned application.”

FDA has long required studies such as actual use, label comprehension, and even human factors’ studies to support Rx to OTC status. This meeting appears to be designed for companies and FDA to align on the data needed to support the switch, whether the product will be appropriate for use in the OTC setting in terms of self-selection and self-administration, and possibly whether an ANCU could be needed to facilitate a consumer’s use without a physician’s involvement. Although there may be precedent for meetings with FDA regarding OTC drug switch data packages, the new law requires FDA to establish a clear pathway for sponsors to obtain such guidance.

Guidance requirement

The law further requires that FDA – within 18 months of OMUFA II's enactment or, by May 2027 – issue 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 2026 – 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.

GAO report

The new law further requires that the General Accountability Office (GAO) – prior to October 2027 – provide a report assessing issues including:

• FDA’s engagement with the public on the issue of OTC switches,
• the number of OTC switch applications that FDA has approved,
• the number of drugs for which an application for a switch was approved subject to an ACNU,
• the average length of time FDA takes to approve OTC switch applications,
• “barriers to timely and predictable review of applications for an Rx-to-nonprescription switch,” and,
• ways that Center for Drug Evaluation and Research (CDER) and the Centers for Medicare & Medicaid Services (CMS) may collaborate on analyzing health insurance claims data for commonly prescribed drugs that appear to be suitable for an OTC switch.

Broader efforts to increase OTC access

FDA is further signaling its focus on increasing drug access to Americans through its December 1 Request for Information (RFI) “on how to increase access to nonprescription drugs,” for which a public meeting will be held next year. FDA invites comments from stakeholders on the RFI through January 31, 2026.

In addition, Section 6507 on Rx to OTC drug switch applications comes seven months after Trump signed an Executive Order (in April 2025) on “Lowering Drug Prices Once Again by Putting Americans First,” which relatedly required FDA to issue a report – by October 12, 2025 – providing “administrative and legislative” recommendations to “improve the process” by which prescription drugs can be reclassified as OTC, including “recommendations to optimally identify prescription drugs that can be safely provided to patients [OTC].” We speculate that FDA’s development of guidance on Rx to OTC switches under Section 6507 may be informed by potential forthcoming recommendations pursuant to this drug pricing Executive Order.

We also note that, consistent with focus on increasing OTC access through process improvements and transparency, FDA’s Office of Generic Drugs published a new manual of policies and procedure (MAPP) on ANDA labeling updates following a full Rx to OTC switch. Although MAPPs are the agency’s internal policy documents, not guidance documents, they often contain helpful information for industry. This MAPP includes information on the required timing to make a labeling update, and indicates that OGD will notify ANDA applicants of the need to update their ANDA following a switch and track the applicant’s steps to make appropriate changes.

Authored by Heidi Gertner, Elizabeth Jungman, Eman Al-Hassan, and Katie Kramer