OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns
This article was originally published in The Rose Sheet
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.
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FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
House Energy and Commerce Democrat and Republican members who back monograph reform are co-sponsors of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, which also includes provisions largely tracking with standalone monograph reform legislation that passed the House in July, including allowing 18-month market exclusivity periods for some ingredients, formulations or indications added to a monograph.
Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance
Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.