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House passes OTC Monograph Reform Legislation

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WASHINGTON — The U.S. House of Representatives has passed H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 – bipartisan legislation sponsored by Representatives Bob Latta (R, Ohio), Diana DeGette (D, Colo.), Energy and Commerce Health Subcommittee Chairman Michael Burgess (R, Texas), Energy and Commerce Health Subcommittee Vice Chairman Brett Guthrie (R, Ky.), Energy and Commerce Health Subcommittee Ranking Member Gene Green (D, Texas), and Rep. Debbie Dingell (D, Mich.).

The legislation, which passed the House floor by voice vote, would reform and modernize the OTC Monograph system – the regulatory system that oversees the majority of over-the-counter (O-T-C) medicines.

“Today’s House vote is a very important step forward for OTC Monograph reform,” said Consumer Healthcare Products Association (CHPA) president and chief executive officer Scott Melville. “We are one step closer to creating a modern regulatory system for the modern OTC marketplace that is more transparent, more nimble, and more accommodating to innovation which is precisely what today’s modern consumer desires.”
The House and Senate legislation include several important policy reforms that will streamline the regulatory process, allow for faster safety label changes, provide more resources for the Food and Drug Administration to regulate O-T-C medicines, and enable innovation to provide consumers with additional self-care choices.
“CHPA applauds the House of Representatives for moving this legislative package forward,” said Melville. “We also thank the Energy and Commerce Committee, along with Representatives Latta, DeGette, Burgess, Guthrie, Green, and Dingell for their ongoing leadership and commitment to modernizing the O-T-C Monograph system. We are encouraged by the ongoing, bipartisan momentum behind this reform effort and look forward to seeing the Senate consider O-T-C Monograph reform soon. We remain optimistic that this important legislation will be enacted into law this year.”


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