WASHINGTON – The Consumer Healthcare Products Association (CHPA) released the below statement today following the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee’s full markup of S. 2292, the Over-the-Counter Monograph Drug User Fee Amendments, which passed unanimously out of Committee, and includes key provisions to advance non-animal testing, update sunscreen standards, and clarify the Rx-to-OTC switch process:
"CHPA applauds Senators Jim Banks (R-IN), Tim Kaine (D-VA), Jon Husted (R-OH), Andy Kim (D-NJ), Roger Marshall (R-KS), Maggie Hassan (D-NH) and the Senate HELP Committee for advancing bipartisan policies that promote innovation, safety, and access across the self-care space. This legislation marks real progress in three critical areas: modernizing outdated animal testing standards for sunscreens and all other over-the-counter (OTC) topicals, creating a clearer path for bringing new sunscreen filters to market, and bringing more clarity to the Rx-to-OTC switch process to help Americans access the self-care products they need, safely and conveniently.
“While today’s progress on this legislation in the Senate is meaningful, it’s imperative Congress take action to ensure this bill reaches its full potential by including clarification of the Generally Recognized as Safe and Effective (GRAS/E) standard, championed by Senators Jim Banks and Andy Kim. Without this, regulatory uncertainty will continue to impede innovation under the OTC monograph system. Ensuring this clarification is included in the final bill is essential to giving industry and FDA the clarity needed to bring new products to consumers while maintaining strong safety standards. CHPA thanks Senators Banks and Kim for their leadership on this issue and remains committed to working with congressional leaders to ensure this final fix is included, solidifying a modern, science-driven regulatory system that meets the needs of today’s consumers.”
Background:
It also requires FDA to account for historical data in the final administrative order on pending OTC sunscreen active ingredient submissions. This will help bring new sunscreen filters to the U.S. market, expanding access to the latest sun care innovations already available to consumers around the world. Also included is language to provide greater clarity and predictability for the Rx-to-OTC switch process. Finally, the agreed-to legislation includes language on details in FDA’s annual reports to Congress on the OMUFA program.
However, there is strong bipartisan support—echoed by the self-care industry—for making additional improvements to the bill. Chief among them is the need for a clarification of the Generally Recognized as Safe and Effective (GRAS/E) standard, which must be addressed in the final legislation developed through the House-Senate conferencing process. This clarification is essential to ensuring regulatory certainty for future OTC innovation and reinforcing the strength of the monograph system. While GRAS/E language was not included in the manager’s amendment, Senator Andy Kim (D-NJ) offered and withdrew an amendment on this issue during markup and signaled the need for continued work on the issue.
