WASHINGTON – The Consumer Healthcare Products Association (CHPA) released the following statement today applauding U.S. Senators Jim Banks (R-IN) and Tim Kaine (D-VA) for introducing S. 2292, bipartisan legislation to reauthorize the Over-the-Counter Monograph User Fee Act (OMUFA). This critical legislation will continue to advance the modernization of the OTC monograph system and ensure the U.S. Food and Drug Administration (FDA) has the resources necessary to support a timely, science-based review of OTC medicines.
“CHPA commends Senators Banks and Kaine for their leadership in introducing this important legislation and for their continued support of accessible, affordable self-care options,” said CHPA president & CEO Scott Melville. “We’re encouraged by the Senate’s commitment to strengthening the monograph system and look forward to working together to refine the bill in ways that protect public health and unlock innovation.
“As Congress considers this reauthorization, CHPA urges the inclusion of a clear reaffirmation of the Generally Recognized as Safe and Effective (GRAS/E) standard, the cornerstone of OTC drug regulation. GRAS/E ensures that OTC medicines are reviewed through a transparent, science-based process that is distinct from the prescription drug model, giving consumers timely access to safe, effective, and affordable products without unnecessary regulatory burdens. This clarity is essential to restoring confidence in the monograph pathway, encouraging innovation, and addressing the stalled progress on product improvements that Americans want and need.
“We also strongly support language that promotes the use of modern, scientifically advanced non-animal testing methods for all topical products, including sunscreens. These tools can deliver rigorous safety data while speeding innovation and aligning with global standards. CHPA calls on the Senate HELP Committee to reaffirm GRAS/E and adopt these common-sense, bipartisan improvements that will ensure consumers continue to benefit from timely access to the latest innovations in self-care."