Pros and cons of FDA's push for nonprescription drugs

This article originally appeared on Law360.

Recently, the commissioner endorsed a mass transition to more nonprescription drugs, arguing that this would allow consumers to bypass the money games of prescription drug pricing and sidestep the medical industrial complex. In his view, the matter is simple: Drugs that are safe, have no potential for abuse, do not require laboratory testing and do not need close monitoring should be available without a prescription.

To achieve this goal, FDA is providing more clarity and transparency on the approval process and standards for novel OTC drugs and prescription-to-OTC switches. FDA is also embracing new tools and pathways to make more medications available without a prescription, such as OTC approvals with additional conditions for nonprescription use, or ACNU.

In addition to the drug affordability and price transparency issues highlighted by the commissioner, this renewed focus on the OTC market is also a response to long-standing calls for greater patient autonomy and easier access, and a recognition of the evolving landscape of self-care, digital health and public health needs.

This article explores FDA's recent initiatives, the regulatory and policy changes underpinning this shift, and the potential benefits and challenges of expanding OTC drug availability.

Building Momentum for Rx-to-OTC Switches

FDA's renewed focus on Rx-to-OTC switches is rooted in a deliberate effort to expand patient access to essential medications, reduce unnecessary barriers in the health care system, and modernize a regulatory framework that has historically drawn a sharp line between prescription and nonprescription drugs. By enabling more drugs to be sold over the counter, FDA aims to:

• Lower drug prices and increase price transparency. The Trump administration views OTC switches as a key component of its plan to lower drug prices.
• Lower overall health care costs by reducing the frequency of health care appointments for conditions that are self-diagnosable or time-sensitive, such as allergies, contraception or opioid overdose reversal.
• Empower consumers to take greater control over their health, particularly for conditions that can be safely managed without ongoing medical supervision.

In 2023, FDA made two high-profile Rx-to-OTC switches: naloxone and norgestrel. Historically, however, FDA has only approved a handful of switches annually.

FDA recently removed the director of its Office for Nonprescription Drugs, in a move reportedly related to the small number of approved switches, though that rationale may not reflect the deep disincentives for sponsors to enter the less lucrative OTC market. At this time, it's unclear whether and how FDA will be able to achieve its goal to dramatically accelerate the slow historic pace of OTC transitions.

In December 2025, the agency issued a request for information seeking input from stakeholders on how to increase access to nonprescription drugs. The agency is soliciting feedback on scientific, regulatory and practical challenges, as well as opportunities for innovation. FDA plans to hold a public meeting this year to further explore these issues.

The recent reauthorization of the Over-the-Counter Monograph User Fee Program includes several provisions aimed to further support Rx-to-OTC switches. The new law directs FDA to issue industry guidance by May 2027 to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs, including in the Rx-to-OTC switches.

The guidance must:

• Establish a process to seek meetings with the agency to discuss potential Rx-to-OTC switches;
• Describe how to leverage existing data sources, including medical literature, previous safety or effectiveness findings, the results of significant human experience with the drug, unpublished studies and other sources of data and information;
• Clarify evidentiary requirements for approval, including how to demonstrate that consumers can appropriately self-select and use the drug and comprehend the nonprescription drug label; and
• Provide recommendations for how novel mechanisms, such as mobile applications and decisions aids, can be incorporated into the information submitted in support of an application for an Rx-to-OTC switch.

The law also directs the U.S. Government Accountability Office to issue a report to Congress by November with approval statistics on recent switches. The report must also detail any barriers to timely and predictable review of switch applications.

Expanding the Counter With a New Tool: Additional Condition for Nonprescription Use

One major recent OTC innovation is the introduction of the ACNU pathway. This new rule allows FDA to approve OTC drugs that require more than just clear labeling to ensure safe use.

For example, when labeling alone is insufficient, sponsors can propose technology-enabled safeguards — such as digital questionnaires or apps — to help consumers determine if a drug is appropriate for them without the need for a health care provider's input.

The ACNU pathway is intentionally flexible, potentially opening the door to OTC access for drugs that previously could not meet traditional switch criteria.

While FDA has not yet approved a nonprescription drug using ACNU, the pathway is seen as a promising tool for pushing the bounds of what we view as over the counter and ultimately expanding the range of OTC medications. The first approvals of nonprescription drugs with ACNU will serve as important test cases for the new regulatory model.

Promises and Challenges

FDA's current focus on the OTC market purports to offer a simple fix to a complex health ecosystem. The promises are enticing. The shift would significantly increase access to important medications and reduce friction in the health care system.

Moving to retail shelves may also increase drug affordability and price transparency and otherwise reduce the burden on the health care system. OTC availability empowers individuals to take greater control over their health, especially for conditions that are well-understood and manageable without ongoing medical supervision.

There are trade-offs, however, to increased access and reduced oversight. The chief concern is safety. Transferring responsibility for diagnosis and oversight from health care professionals to consumers can increase the risk of misuse, delayed diagnosis or inappropriate use—issues that have historically led FDA to reject some switch proposals.

Equity is another challenge, since OTC drugs are often not covered by insurance, which may make them less affordable for some patients. For the same reasons, Rx-to-OTC switches may not be attractive to drug sponsors, for whom margins may be higher for prescription products.

The implementation of new pathways like ACNU also introduces additional compliance and monitoring obligations for sponsors, as well as operational complexities related to untested technologies.

Even with a commitment for increased clarity and support from FDA, the regulatory burden to demonstrate that a switch is warranted can be substantial. The shift to OTC status may also increase a sponsor's liability exposure, as broader consumer access may lead to more adverse events or misuse.

Other market dynamics—including the need to invest in new marketing strategies—can further erode the commercial incentives for sponsors to pursue an OTC switch.

In light of these concerns, it's unclear whether FDA will be able to accomplish the transformation it's pushing, or if we'll only see incremental changes. As Makary and FDA continue to advance this agenda, all eyes will be on how the agency and industry navigate the complex trade-offs inherent in expanding OTC drug access.

With thoughtful policy, stakeholder engagement and a commitment to evidence-based decision-making, FDA's efforts could reshape the landscape of medication access and retail pharmacy aisles for years to come.

Authored by Heidi Gertner, Elizabeth Jungman, and Eva Schifini

This article originally appeared on Law360.