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Saturday, March 29, 2025

Congressmen announce hearing on FDA regulation of OTC monograph drugs

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Cathy McMorris Rodgers - Chair of the House Energy and Commerce Committee | Official U.S. House headshot

Cathy McMorris Rodgers - Chair of the House Energy and Commerce Committee | Official U.S. House headshot

Today, Congressman Brett Guthrie of Kentucky and Congressman Earl L. "Buddy" Carter of Georgia announced an upcoming hearing focused on the regulation of over-the-counter (OTC) monograph drugs by the Food and Drug Administration (FDA). Guthrie serves as Chairman of the House Committee on Energy and Commerce, while Carter chairs the Subcommittee on Health.

The hearing is titled "Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs." It aims to explore how OTC drugs are regulated by the FDA and will provide a platform for experts and stakeholders to discuss the current state and challenges associated with the FDA's Over-The-Counter Monograph Drug User Fee Program.

"From providing relief to headaches, to alleviating symptoms of the common cold, over-the-counter drugs play an important part in helping Americans live healthier lives," said Chairmen Guthrie and Carter. "This hearing will give Members an opportunity to hear from experts and stakeholders and how the FDA’s Over-The-Counter Monograph Drug User Fee Program is working and what challenges may persist."

The Subcommittee on Health will hold this hearing on Tuesday, April 1, 2025, at 10:15 AM ET. It will take place in room 2123 of the Rayburn House Office Building. The event is open to both the public and press, with a live stream available online at energycommerce.house.gov.

For inquiries regarding the hearing, Emma Schultheis can be contacted via email at Emma.Schultheis@mail.house.gov. Press-related questions should be directed to Matthew VanHyfte at Matthew.VanHyfte@mail.house.gov.

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