Chairman Griffith, Vice Chair Harshbarger Celebrate Inaugural FDA Voucher to USAntibiotics in Bristol

The U.S. Food and Drug Administration (FDA) recently announced that it will provide USAntibiotics - located in Bristol, Tennessee - a National Priority Voucher for the company's Augmentin XR (Amoxicillin Clavulanic Potassium) product. This medication treats community-acquired pneumonia and acute bacterial sinusitis caused by penicillin-resistant bacteria.

USAntibiotics was selected as part of the FDA Commissioner's National Priority Voucher (CNPV) Pilot Program, which is designed to expedite the review of pharmaceuticals that advance critical public health and national security priorities, including domestic drug manufacturing.

U.S. Representative Morgan Griffith (R-VA), Chairman of the House Committee on Energy and Commerce Subcommittee on Health, and U.S. Representative Diana Harshbarger (R-TN), Vice Chair of the Health Subcommittee, welcomed this news and applauded the work of USAntibiotics.

"The FDA created the CNPV Pilot Program to help American prescription drug and biological product developers meet the moment to power domestic drug manufacturing," said Chairman Griffith and Vice Chair Harshbarger. "With this recent announcement, Bristol's USAntibiotics can grow as a leading American pharmaceutical manufacturer of amoxicillin to help treat American communities. As Health Subcommittee Chairman and Vice Chair, we remain steadfast in pushing for 'America First' policies that attract companies to invest in the United States and help them manufacture safe, effective and serviceable drugs for the American people."

BACKGROUND

In 2021, USAntibiotics opened its facility in Bristol, Tennessee.

Chairman Griffith and Vice Chair Harshbarger toured USAntibiotics in June 2024.

Key benefits of the CNPV Pilot Program include faster review times, collaborative and robust review efforts and advancement of U.S. national health priorities. Following submission of a complete application, the new voucher promises a review decision within 1-2 months as opposed to the typical 10-12 months.

This year, multiple companies announced billion-dollar investments in Virginia to increase domestic pharmaceutical manufacturing. Eli Lilly, Merck and AstraZeneca all plan to build or expand operations in the Commonwealth.

The USAntibiotics press release can be found here.

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