Checkable Health, the company behind what could be the first FDA-authorized at-home strep test, is calling for bold regulatory reform after decades of stagnation in prescription-to-over-the-counter (Rx-to-OTC) innovation. Fueled by recent Trump administration directives, the FDA has been asked to return within 180 days with a streamlined framework for Rx-to-OTC approvals-a move Checkable believes could finally unlock the future of consumer healthcare.
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Checkable Health Urges Rx-to-OTC Reform: 'It's Time to End the Bottleneck'
“The FDA's current process discourages innovation at the exact moment Americans are demanding more control over their health,” said Patty Post, founder and CEO of Checkable. “We need a regulatory model built for the 21st century-and this mandate may be the inflection point we've waited for.”
Bringing the Voice of Innovation to WashingtonPatty Post will speak on May 15 at the Food and Drug Law Institute (FDLI) Annual Conference in Washington, D.C., joining the panel:
Home as a Healthcare Hub:CDRH's Vision and What it Means for Device CompaniesModerated by Jeremiah Kelly, Partner, Venable LLP
The panel will explore how manufacturers can develop and commercialize medical devices that function safely and effectively in the home. Post will bring a firsthand perspective from a startup navigating the regulatory environment to deliver diagnostic tools directly to consumers.
“For families, the home is often the first place care begins-our policies and products should reflect that,” said Post. “We need regulation that meets patients where they are.”
Rx-to-OTC Reform: A Missed Opportunity-Until NowBetween 2019 and 2024, fewer than 10 drugs were approved for over-the-counter (OTC) use-compared to 18 in the previous five years. Safe, proven products like antihistamines, migraine treatments, and diagnostic tools remain prescription -only not due to scientific concerns , but because of cost, bureaucracy, and risk aversion.
According to industry estimates, more than 80% of urgent care visits for sore throats result in unnecessary prescriptions, adding strain and expense to an already overloaded system.
“This is a systemic failure that costs billions and delays care,” said Post. “And it's a burden that falls squarely on families.”
The Checkable Mission: Redefining What's Possible at HomeCheckable's journey began with a simple question: Why can't I test for strep throat at home? That question launched a multi-year regulatory and clinical journey to bring the first FDA-authorized, at-home strep test to market. The company is poised to become the first in the U.S. to do so.
“This isn't just about Checkable,” Post emphasized. “It's about unleashing a new wave of innovation-one that puts families in control of their health.”
A National Call to ActCheckable is urging policymakers, healthcare leaders, and fellow entrepreneurs to support regulatory frameworks that speed access to safe, effective OTC solutions.
“This is a once-in-a-generation opportunity,” Post said. “We can transform healthcare access-but only if we act boldly and collectively. The future of healthcare doesn't live in a waiting room. It lives at home.”
Checkable and Powers of ReasoningTo ensure its message reaches consumers in a clear, compelling, and impactful way at launch, Checkable has partnered with Powers of Reasoning, a media and strategy firm known for its deep expertise across the ecosystem. Together, they are building a data-driven approach to awareness, education, and access-so that more families can confidently take health into their own hands.
About Powers of ReasoningPowers of Reasoning is a forward-thinking agency at the intersection of technology, data, and media strategy. This MWBE-certified media agency is committed to transforming the marketing landscape by offering innovative, performance-driven solutions. Through PowerHouse Engine and other tools, we partner with our clients to deliver measurable results, empower their marketing efforts, and shape the future of media buying and optimization.
Contact: gretchen.sword@powersofreasoning.com
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SOURCE Checkable Health
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