FDA Commissioner Martin Makary has recently reignited debate over nonprescription drug access with a provocative statement:

“Everything should be over-the-counter” unless a drug is unsafe, addictive, or requires clinical monitoring.

In recent interviews and public comments, Makary has suggested that the default question should shift from “Why can this drug be OTC?” to “Why shouldn’t it be?” when safety and monitoring requirements allow it. He has also pointed to existing regulatory mechanisms -including updates to OTC monographs and newer pathways such as Additional Conditions of Nonprescription Use (ACNU), as tools to expand consumer access.

These comments come as the FDA explores ways to modernize the nonprescription pathway. The agency’s Request for Information on Increasing Access to Nonprescription Drugs, published in the Federal Register on December 2, 2025, invited public input over a two-month comment period that closed February 3, 2026.

The RFI asked stakeholders to respond to several core questions, including:

  • What challenges exist in developing drugs for nonprescription use?
  • What are the biggest opportunities to improve access?
  • How could stakeholders collaborate to increase safe access?
  • What scientific barriers limit progress?
  • What tools or technologies could support nonprescription use?
  • Which conditions might be appropriate for OTC treatment?
  • What topics should be discussed at a 2026 public meeting?

The respondents represent a broad cross-section of the healthcare ecosystem: patients, advocacy groups, consumer healthcare manufacturers, innovator and generic pharmaceutical companies, pharmacy organizations, digital health firms, business associations, and standards organizations.

A full review of the comments reveals several consistent themes, and a few questions that deserve further discussions.

Access Friction Is Widely Recognized

Across patients, advocacy groups, and industry alike, the same issues appear repeatedly:

  • High deductibles and out-of-pocket costs
  • Appointment delays and provider shortages
  • Administrative burden
  • Chronic undertreatment of common conditions

Individual commenters described abandoning therapies because of cost or difficulty accessing a prescription. Industry and policy groups pointed to broader system pressures, including physician shortages and lost productivity when patients must take time off work to obtain routine medications.

There is little disagreement that access barriers exist and affect both individuals and the healthcare system.

The Switch Pathway Is Seen as Difficult to Navigate

Many industry submissions, including consumer healthcare manufacturers and trade groups -argue that the Rx-to-OTC switch pathway lacks predictability.

Common concerns include:

  • Shifting evidentiary expectations
  • Multiple rounds of consumer behavior studies
  • Increasing endpoint requirements
  • Development programs that can extend close to a decade

Stakeholders emphasize the importance of clear expectations and early alignment with regulators to support efficient development.

ACNU Is the Structural Pivot

The debate around Additional Conditions of Nonprescription Use (ACNU) is central to the theme.

Some stakeholders, particularly digital health companies, view ACNU as a way to expand access while maintaining safeguards through:

  • digital screening tools
  • structured eligibility checks
  • integrated safety systems.

Others raise questions about operational complexity, insurance implications, and how the model would function in markets with multiple manufacturers.

In short, ACNU is widely recognized as an important policy development, but views differ on how it should be implemented.

The Cost Question Is More Nuanced Than It First Appears

Several submissions cite projected healthcare savings associated with expanded OTC access.

Historical examples often referenced include:

  • Loratadine, a second-generation antihistamine whose OTC transition has been associated in decision models with approximately $4 billion in annual societal savings and substantial quality-of-life gains due to reduced substitution of sedating first-generation antihistamines.
  • Nicotine replacement therapies, where the switch of products such as Nicorette increased consumer access and supported smoking cessation efforts.

Other analyses of OTC availability, including for H2-receptor antagonists, show reductions in prescription utilization without increases in physician visits.

At the same time, empirical research suggests a more complex picture:

  • Some cost savings arise from reduced physician visits and system spending.
  • In certain cases, costs may shift from insurers to patients, since OTC products may not be covered by insurance.
  • Generic prescription drugs can sometimes remain less expensive for insured patients than OTC equivalents.

In other words, while projected savings are substantial, longitudinal real-world data across multiple therapeutic categories remain limited.

Several Questions Deserve Further Study

The docket highlights areas where more empirical evidence could strengthen policy decisions.

Examples include:

Post-switch economic impact

  • Longitudinal claims studies comparing pre- and post-switch out-of-pocket costs
  • Insurance coverage dynamics following switches
  • Impact on generic competition and supply

Clinical outcomes

  • Comparative outcomes across prescription access, OTC availability, and emerging digital access pathways
  • Rates of delayed diagnosis for chronic or “silent” conditions

Behavioral evidence thresholds

How consumer comprehension and self-selection standards should be calibrated relative to real-world prescription adherence

ACNU implementation

Operational models that support safe scaling across therapeutic areas

These questions suggest opportunities for cross-sector research and collaboration.

One Observation From the Docket

One interesting aspect of the submissions is what they emphasize, and what they do not.

Across all 50 comments, the discussion focuses primarily on two models of medication access:

  • Traditional prescription pathways
  • Nonprescription / OTC pathways, including ACNU.

Relatively little attention is given to another development that has been expanding rapidly in parallel: direct-to-patient prescription models enabled by telehealth and digital prescribing platforms.

These models are increasingly visible in areas such as weight management, men’s and women’s health, and chronic disease management.

While part of this is by design, the docket was focused on nonprescription drugs, it is important to acknowledge that the broader landscape of medication access is evolving through multiple channels simultaneously.

Understanding how these models interact, and where they complement or compete with one another, is an important topic as policy discussions continue.

Looking Ahead

Makary’s recent comments signal that expanding nonprescription access is likely to remain a major FDA policy priority.

The 50 public submissions reflect interest in that goal, alongside important differences in how stakeholders view risk, health economics implications, and operational models.

As the FDA prepares for its planned public meeting in 2026, the conversation may benefit from continued dialogue across sectors, including regulators, manufacturers, clinicians, payers, and digital health innovators.

Improving access to medications is a shared objective.

The challenge will be designing policies that place consumers/patients at the center, delivering better access, better outcomes, and better care while balancing safety, affordability, and innovation as the healthcare landscape continues to evolve.