OTC Monograph Reform Momentum Carries Potential Exclusivity Snag
This article was originally published in The Rose Sheet
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.
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Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.
The New Jersey Democrat introduced multiple cosmetics-related amendments during the House Health Subcommittee's markup of draft OTC monograph reform legislation. While ultimately nothing came of the proposed measures, it's clear that Pallone remains intent on updating cosmetics regulations to require facility registration, adverse event reporting and good manufacturing practices, among other aims.
Members of the House Health Subcommittee suggest their support for potential OTC monograph reform legislation depends on including provisions that would add substantial details to FDA's oversight of cosmetics manufacturers and a related user fee program.