Senate OTC Monograph Bill Boosts Industry Hopes For Passage This Year
This article was originally published in The Pink Sheet
Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
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Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.
FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.
The Personal Care Products Council is pivoting to focus on passing cosmetics modernization legislation after mid-term congressional elections, while still hopeful the language could go through as part of FDA user-fee reauthorization. Karin Ross, executive VP, government affairs at PCPC, discussed the situation at the trade group’s Leadership Summit in Washington.