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Checkable Health Urges Rx-to-OTC Reform: 'It's Time to End the Bottleneck'

  • On May 14, 2025, Checkable Health, based in Fargo, N.D., urged the FDA to adopt bold regulatory reforms for Rx-to-OTC drug approvals.
  • The call follows years of minimal OTC approvals, with fewer than 10 drugs approved from 2019 to 2024, down from 18 in the prior five years.
  • Checkable, developing a potential FDA-authorized at-home strep test, highlights that prescription-only status often stems from cost, bureaucracy, and risk aversion, not scientific reasons.
  • Founder Patty Post criticized the FDA’s existing procedures for hindering innovation just as the public seeks greater autonomy over their healthcare, calling the situation a widespread issue that results in substantial financial losses and prolongs access to treatment.
  • Checkable urges policymakers, healthcare leaders, and entrepreneurs to support a 21st-century regulatory model that speeds OTC access and enables families to take more control over their health.
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Checkable Health Urges Rx-to-OTC Reform: 'It's Time to End the Bottleneck'

FARGO, N.D., May 14, 2025 /PRNewswire/ -- 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…

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KWWL broke the news in Waterloo, United States on Wednesday, May 14, 2025.
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