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Wednesday, April 2, 2025

Rep. Carter emphasizes timely reauthorization of the OTC drug user fee program

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Buddy Carter U.S. House of Representatives from Georgia's 1st district | Official U.S. House Headshot

Buddy Carter U.S. House of Representatives from Georgia's 1st district | Official U.S. House Headshot

Rep. Earl L. "Buddy" Carter (R-GA), as Chairman of the Subcommittee on Health, addressed a hearing on the regulation of over-the-counter (OTC) monograph drugs. He highlighted the importance of the Over-the-Counter Monograph Drug User Fee Program, known as "OMUFA," which is due for reauthorization as the current authority expires on September 30, 2025.

In his statement, Rep. Carter referred to the enactment of the initial bill nearly five years ago. He noted, “The enactment of this program reformed and modernized the regulation of OTC monograph drugs and authorized the FDA to assess and collect user fees dedicated to OTC monograph drug activities.” The reforms, supported by industry and public health stakeholders, have enhanced the FDA's resources for increasing access to quality drugs and self-care products.

OTC medications, which are routinely used by nearly 90% of Americans for common ailments, save the healthcare system billions annually. Carter emphasized the significance of affordable and accessible OTC drugs and their role in public health.

Rep. Carter also acknowledged the efforts of Symrise, a company that operates in Georgia’s First Congressional District, which faced a serious setback in 2022 when its plant experienced a fire. “Symrise made the strategic decision to re-invest in the site and restore its capacity in my community," he stated, underlining the company's successful recovery and full restoration of operations.

Additionally, Rep. Carter highlighted Mr. Kevin Menzel, President of Focus Consumer Healthcare, a subsidiary of Kobayashi Healthcare, which significantly contributes to the local economy. Kobayashi, founded in Japan, has expanded its U.S. operations, particularly in Dalton, Georgia. Carter praised these companies for their positive impact on local employment and their alignment with Georgia's pro-business environment.

“Success stories such as Symrise and Kobayashi highlight why it is critical for this Subcommittee to reauthorize the Over-the-Counter Monograph Drug User Fee Program in a timely manner," Carter concluded, emphasizing the program's role in bringing jobs back to America and ensuring access to safe OTC drugs.

Rep. Carter expressed eagerness to continue the collaboration with colleagues to secure the reauthorization of OMUFA.

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