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Source: Congress.gov
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Transcript
I want to welcome everyone to today's hearing on the over-the-counter monograph drug user fee program, referred to as a MUFA. I'm especially pleased that we are talking about the reauthorization of this program as almost five years to the date the initial bill, sponsored by my good friend from Ohio, Representative Latta, as well as one of Georgia's finest, Senator Johnny Isakson, was signed into law by President Trump in March of 2020. 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. Industry and public health stakeholders supported these reforms, which have provided FDA with additional resources and tools to streamline the monograph process to increase access to quality, commonly used drugs and self-care products for the American consumer. This program is designed to improve innovation while maintaining the FDA gold standard of safety. The current legislative authority for a MUFA expires September the 30th, 2025. Again, September 30, 2025, at which point new legislation will be required to reauthorize the over-the-counter monograph user fee program for another five-year term. Over-the-counter medications are widely used to treat common ailments such as colds, headaches, and seasonal allergies. In fact, nearly nine out of every ten Americans use OTC medications regularly and trust these affordable remedies to get well and stay healthy. Safe, reliable, and affordable OTC drugs allow consumers to treat common ailments at home, usually without visiting a health care provider, saving the health care system billions annually. A particular note is a company named Simrise. They own and operate a manufacturing plant in Georgia's first congressional district that I have the honor and privilege of representing. SEMRISE manufactures aroma molecules and fragrance ingredients which are used in various consumer products across a number of product categories.
They also manufacture two of the key UV filters that are commonly used in many OTC sunscreens on the market today. Sadly, SEMRISE Colonel's Island plant experienced a serious fire in 2022. SEMRISE made the strategic decision to reinvest in the site and restore its capacity in my community at a time when other companies were leaving. They successfully completed renovations and today the plant is again fully operational back at its pre-fire capacity. This is a real success story and we are grateful for their commitment to Georgia. We are also fortunate to have Mr. Kevin Menzel, before our committee today. Mr. Menzel is president of Focus Consumer Healthcare, which is a wholly owned subsidiary of Kobayashi Healthcare. Kobayashi was founded as a family company in 1886 in Japan. They established a presidency in the United States in 1998 and maintained manufacturing and operations in Dalton, Georgia, employing 270 people with products ranging from OTC medicines and supplements to recreational products like hot hands hand warmers.
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