The Coming Wave of OTC Innovation: How the FDA’s 180-Day Mandate Could Reshape Healthcare

The U.S. healthcare system is ripe for transformation—and a recent Executive Order from the White House might finally signal the shift we’ve been waiting for.

On April 15, the Biden administration issued a directive aimed at expanding over-the-counter (OTC) access to prescription medications. Headlines quickly speculated a 180-day mandate for the FDA to review all Rx-to-OTC switches. But let’s clarify what’s really happening—and why it still matters.

No, the FDA Isn’t Being Ordered to Approve Switches in 180 Days

The Executive Order does not direct the FDA to complete switch reviews in 180 days. Instead, it gives the FDA 180 days to come back with recommendations on how to improve the switch process, including:

• Ways to identify which drugs are suitable for OTC access
• Regulatory barriers that could be streamlined
• Legislative changes that may be necessary

That means we’re expecting an update this October—not a rule change, but a roadmap.

Still, this is significant. It signals a federal-level urgency to modernize a system that, for the last decade, has been notoriously slow and opaque.

The Switch Landscape: Stalled Progress, Untapped Potential

Between 2019 and 2024, fewer than 10 drugs made the switch from prescription to OTC. Compare that to the five years prior, and you’ll see the drop-off is dramatic. It’s not for lack of science or safety—it’s because the process has become too complex, too costly, and too uncertain for many manufacturers to pursue.

For large pharma, the return on investment often doesn’t justify the risk: spend years navigating regulatory hurdles, only to end up with a lower-margin product and higher consumer marketing demands.

That has left a host of safe, effective, and widely used prescription products stuck in limbo.

Why This Executive Order Still Matters

While not a mandate, the order represents momentum.

It’s the federal government saying: We know the Rx-to-OTC pathway is broken, and we’re taking a hard look at fixing it.

If the FDA’s forthcoming recommendations lead to regulatory streamlining—or even new legislative authority—we could see a more commercially viable path for companies looking to bring proven products to consumers, faster.

And if paired with other federal efforts to lower drug prices and increase price transparency, this could accelerate a broader shift: from provider-centered care to consumer-enabled health solutions.

Where We See the Opportunity

At Checkable, this is the future we’ve been building toward.

We started with a simple question: Why can’t I test for strep throat at home?

That question became a mission—to bring clinical-quality diagnostics into the home. Through years of research, human factors testing, and close work with the FDA, we’ve laid the foundation for safe, effective OTC diagnostic care.

And we’re not alone. Across the industry, there are dozens of clinic-based tools, diagnostic tests, and chronic care solutions ready for responsible OTC use. Unlocking this access means better outcomes, earlier interventions, and lower costs for patients.

We’re watching October closely. The FDA’s response to the Executive Order could set the tone for a new era in healthcare—one where more Americans can take control of their health, right from their own homes.