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OTC Monograph Reform, User Fee Legislation Coming 'Any Day' – CHPA

 
• By Eileen Francis

Imminent OTC monograph reform legislation signals an agreement between industry and FDA on details of a proposal, which also includes a potential user fee program. CHPA also is hopeful for legislation restoring direct OTC drug purchases with pre-tax savings accounts.

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Legislation with proposals that drug firms were hesitant to get behind – reforming FDA's OTC drug monograph program and establishing a user fee program to support the agency's work – is close to surfacing in Congress with the industry's backing.

A separate change also requiring legislation but that the industry has backed from the start, eliminating the Affordable Care Act requirement that consumers have prescriptions to buy OTC drugs with...

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