PRESS RELEASE – Sens. Jon Husted (R-Ohio) and Maggie Hassan (D-N.H.) have introduced the Streamlined Market Access and Reform for Therapeutics Over-the-Counter (SMART OTC) Act, which would modernize the Food and Drug
Administration’s (FDA) process for giving certain prescription drugs status as over-the-counter (OTC) options.
“Ohioans deserve access to affordable, high-quality health care. That’s why I introduced a bill to cut unnecessary FDA barriers and make proven, over-the-counter medicines more accessible—helping lower costs and improve health for families across our state,” said Husted.
“As Americans face sky-high costs, including for prescription drugs, this bipartisan legislation will help increase patient access to low-cost medications by requiring the FDA to more clearly communicate the agency’s process for switching medications from prescription to nonprescription status.”
“I’ll continue to work with my colleagues across the aisle to lower health care costs for Granite Staters and ensure that families across the country can access the lifesaving care that they need,” said Hassan.
“As Americans face sky-high costs, including for prescription drugs, this bipartisan legislation will help increase patient access to low-cost medications by requiring the FDA to more clearly communicate the agency’s process for
switching medications from prescription to nonprescription status. I’ll continue to work with my colleagues across the aisle to lower health care costs for Granite Staters and ensure that families across the country can access the lifesaving care that they need,” said Hassan.
Health care costs have risen in recent years. Part of those costs arise when safe, proven medications are stuck behind the prescription counter. Every dollar spent on OTC medications saves the U.S. health care system $7.33.
The SMART OTC Act builds on Husted’s work to provide high-quality health care for Ohioans. Husted’s bill would:
- Instruct the FDA to explain clearly what types of drug categories might be candidates for patients to access OTC.
- Require the FDA to meet with sponsors of new applications during the initial planning stages of switching a medication to OTC status in order to provide recommendations on what standards the drug must meet to become available without a prescription.
- Require the Government Accountability Office to publish a report on how many prescription drugs the FDA reviews and approves for OTC availability.