America’s medicine cabinet hasn’t kept pace with its health care needs. While digital tools and consumer empowerment have transformed nearly every facet of modern health care, prescription-to-over-the-counter (Rx-to-OTC) product switches have slowed to a crawl. The FDA wants to change that. 

Flipping the Switch — Again 

The FDA is pushing to expand consumer access to medicines by encouraging more Rx medicines to move OTC. FDA Commissioner Marty Makary and Center for Drug Evaluation and Research Director George Tidmarsh have both expressed strong support for the Rx-to-OTC switch pathway, with Tidmarsh recently urging manufacturers to think beyond regulatory mechanics and focus on the broader public health benefits these transitions can bring. 

After a wave of switches in the early 2000s that transformed pharmacy shelves, progress has largely stalled. In recent years, only a small number of prescription drugs have successfully transitioned to OTC status — not for lack of opportunity, but because regulatory uncertainty continues to stand in the way. Meanwhile, Americans’ appetite for convenience, privacy, and self-care has only grown. The FDA’s latest signals suggest a renewed effort to break through that inertia and reignite the switch movement. 

Why Switch Matters 

Switching a drug to OTC status isn’t simple. Manufacturers must prove not only that a medicine is safe and effective, but also that consumers can confidently and correctly use it without a doctor’s supervision. This typically requires numerous real-world behavior studies showing that people can self-select and use the product appropriately. 

For many Americans, that independence matters. Millions face barriers to accessing health care — and, by extension, the Rx medications they need — from cost and coverage gaps to provider shortages and pharmacy deserts. These barriers are especially steep for low-income populations and older adults, who already rely heavily on OTC products. In many cases, safe self-care can achieve similar health outcomes to physician-directed care — at a lower cost and more conveniently — helping more people manage their health on their own terms.  

What’s more, for every dollar spent on OTC medicines, the U.S. health care system saves $7.33, accumulating to $167 billion in savings each year — making this a broader public health issue. 

Switching Up the Rules 

The regulatory environment is evolving alongside the growing push for Rx-to-OTC switch. Less than a year ago, the FDA finalized a rule allowing nonprescription products to be marketed with “additional conditions for nonprescription use.” This pathway gives manufacturers flexibility to leverage digital tools, smarter labeling, or in-store prompts to help consumers use switched medicines safely and effectively.  

If the industry responds to the FDA’s call, a new wave of switches could emerge in treatments for allergy, migraine, sexual health, and cardiovascular disease prevention — areas where safe self-management can relieve strains across the health care system and empower patients to act early. Improved access isn’t just about convenience; it’s about delivering meaningful improvements in both personal and public health for all Americans. 

Fueling the Next Switch 

The FDA has made its priorities clear; now it’s up to patients, drug manufacturers, providers, and policymakers to coalesce to modernize access and make self-care a cornerstone of public health. The agency has opened the door to a new era of consumer health — how far it swings will depend on those who seize the opportunity.