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Congresswoman Debbie Dingell (D-MI), Congressman Bob Latta (R-OH), Congresswoman Diana DeGette (D-CO), and Congressman Dan Crenshaw (R-TX), introduced the Over-the-Counter Monograph Drug User Fee Amendments (OMFUA), a bipartisan bill to reauthorize the Over-the-Counter Monograph User Fee Act that has improved access to over-the-counter medicines.  

“Nearly nine out of ten Americans regularly use over the counter medications to quickly, easily, and effectively manage a range of conditions. The Over-the-Counter Monograph Safety, Innovation, and Reform Act has been highly successful in improving OTC drug availability and safety. I’m leading this reauthorization with my bipartisan colleagues to ensure consumers continue to have safe access to the OTC products they depend on, and the U.S. remains a global leader in health and innovation,” Dingell said. 

“The over-the-counter monograph drug user fee program (OMUFA) allows consumers to manage their own care safely and affordably. Five years ago, as an original sponsor of this legislation, my colleagues and I modernized how the FDA regulates most over-the-counter medicines by enacting OMUFA. These reforms transformed a 40-year-old system, making it more efficient, transparent, and open to innovation. I’m proud to lead the reauthorization of this critical program,” Latta said. 

"Millions of Americans rely on over-the-counter medications every day, and FDA’s over-the-counter medicines program ensures those products are safe, effective, and accessible,” DeGette said. “I was proud to play a role in creating OMUFA and to see it through its first five years. Now, as we approach reauthorization, it’s time to build on that success and continue giving FDA the tools it needs to deliver trusted medicines to Americans’ shelves."

“This bipartisan bill empowers the FDA to review over-the-counter medicines quickly and efficiently — without compromising safety. It ensures Americans can trust that the products on their shelves are backed by the latest science, and spares the taxpayer a new obligation,” Crenshaw said.   

The OMUFA bill is endorsed by the Consumer Healthcare Products Association: 

“CHPA applauds Representatives Latta, DeGette, Crenshaw and Dingell for their leadership in introducing this important reauthorization and for their continued support of self-care,” said CHPA President & CEO Scott Melville. “As the industry works to deliver safe, effective, and innovative OTC products to consumers, we look forward to working with Congress on refinements to the bill to ensure the final legislation maximizes the potential of monograph reform and can continue to provide savings and innovation to consumers. That includes inserting provisions into OMUFA to clarify how FDA evaluates the Generally Recognized as Safe and Effective (GRASE) standard, creating a clearer path for early agreement on data needs, and improving the efficiency of making product improvements while maintaining strong safety standards.”