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OTC monograph reform bill passes House

A bill that would bring changes to the OTC monograph system has passed the House of Representatives. H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, was passed by voice vote and includes provisions that would modernize the monograph pathway, which hasn’t had a significant update since its implementation in 1972.

The new bill would allow the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process. Besides aiming to speed up the regulatory process for OTC products, the bill also would give the Food and Drug Administration power to collect user fees to oversee OTC-related work.

“Today’s House vote is a very important step forward for OTC Monograph reform,” said Consumer Healthcare Products Association president and CEO 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.”

With the House’s passage of the bill, proponents now turn their attention to the Senate where the companion legislation was passed by the Senate Health, Education, Labor and Pensions Committee in April.

“CHPA applauds the House of Representatives for moving this legislative package forward,” Melville said. “We are encouraged by the ongoing, bipartisan momentum behind this reform effort and look forward to seeing the Senate consider OTC Monograph reform soon. We remain optimistic that this important legislation will be enacted into law this year.”
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