New law streamlines converting prescriptions to over the counter drugs

WASHINGTON - A bill aimed at streamlining the process of making certain prescription medicines available over the counter has been enacted into law.
The measure requires the Food and Drug Administration to improve the clarity and predictability of its review process when pharmaceutical companies seek to change a drug’s status from prescription to nonprescription.
Sen. Jon Husted, R-Ohio, who introduced the bill with Sen. Maggie Hassan, D-N.H., said the new law creates a clear road map for drug developers and the FDA.
The new law, which amends the Federal Food, Drug, and Cosmetic Act, focuses on standardizing the interactions between the agency and drug sponsors. It specifically directs the Food and Drug Administration to establish formal meetings to discuss applications for a status change.
The agency will now also be required to set performance goals for the length of time it takes to review the applications. In an annual report to Congress, the FDA must detail the average time it took to approve a full or partial switch to nonprescription use.
The report must also address any obstacles the FDA faces in providing a timely review and what efforts the agency has made to engage with public stakeholders.
In addition, the law requires the FDA to analyze health insurance claims data for common prescription drugs that may be suitable for a nonprescription change.
The goal is to better understand which medicines could safely be moved to over-the-counter sales, potentially making them easier for consumers to access.
