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OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns

 
• By Malcolm Spicer

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.

House Energy and Commerce Committee support for legislation to overhaul FDA's OTC monograph drug process is unanimous even though the same can't be said for the bill's proposed 18-month exclusivity period for some products approved under the revised program.

Some Democratic members of the committee question the length of the proposed exclusivity period while others oppose any new exclusivity at all. Nonetheless, they joined with committee Republicans in a...

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