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Checkable Health Advocates for Rx-to-OTC Reform

In a bold move, Checkable Health has issued a call for regulatory reform to facilitate easier transitions from prescription to over-the-counter (Rx-to-OTC) medication approval. As the pioneers behind what may soon be the first FDA-authorized at-home strep test, the company asserts that an outdated regulatory framework is stifling innovation just when consumers need more independence over their healthcare.

Current Regulatory Environment

The existing Rx-to-OTC process has shown significant stagnation, with fewer than ten medications approved for OTC use between 2019 and 2024, a stark contrast to the eighteen approved in the previous five years. Patty Post, CEO and founder of Checkable Health, has described the FDA's current strategy as a deterrent to progress, particularly during a time when many Americans crave more control over their health decisions.

“We need a regulatory model built for the 21st century,” said Post, highlighting the need for reforms as a pivotal moment in healthcare accessibility. Under recent initiatives from the Trump administration, the FDA has been directed to formulate an expedited framework for Rx-to-OTC transitions within 180 days. This initiative has been met with both hope and urgency by Checkable Health.

The Panel Discussion

On May 15, Post is set to speak at the Food and Drug Law Institute (FDLI) Annual Conference in Washington, D.C. During the event, she will join a panel titled "Home as a Healthcare Hub, CDRH's Vision and What it Means for Device Companies." This panel will delve into how medical devices can be safely commercialized for home use. Post aims to share insights from her journey as a startup navigating the complex maze of regulatory practices, emphasizing the necessity for regulations that resonate with the realities of modern family care.

Missed Opportunities for Growth

Historically, the complexities and bureaucracies surrounding the regulatory landscape have led to missed chances for releasing beneficial products that could enhance consumer health and wellbeing. Medications like safe antihistamines and migraine remedies are unnecessarily available only through prescriptions, bolstered by a system that favors risk aversion over innovation. Annually, millions of visits to urgent care for sore throats culminate in unnecessary prescriptions that exacerbate healthcare costs and pressure an already burdened system.

“This systemic failure is costing families billions and delaying crucial care,” Post disclosed. "It's clear: the current model is failing, and families are paying the price."

Checkable’s Groundbreaking Mission

The inspiration behind Checkable Health's innovations comes from a fundamental question: Why shouldn't at-home strep testing be a reality? This perspective provoked a multi-year journey centered on pushing boundaries and redefining healthcare norms. The company’s mission emphasizes empowering families to take charge of their health through easy access to effective diagnostic tools.

A Call to Action

Checkable Health's message extends a call to action to policymakers, healthcare professionals, and fellow innovators to back initiatives that streamline the journey to safe OTC solutions. Post asserts, "This is a once-in-a-lifetime opportunity to reshape how we access and approach healthcare. The focus should be on delivering healthcare where it begins: at home."

Partnership with Powers of Reasoning

In line with their advocacy, Checkable has collaborated with Powers of Reasoning, a strategy firm renowned for integrating media with data-focused solutions. This partnership aims to amplify awareness and education surrounding health management, ensuring families can confidently manage their health journeys.

Powers of Reasoning stands at the forefront of innovative marketing solutions, committed to reshaping the landscape for their clients through data-driven outreach and performance strategies.

As Checkable Health paves the way for profound changes in the healthcare access landscape, it's a potent reminder that with focused efforts and collective momentum, the future of healthcare can indeed live at home.