Codeine Concerns Cough Up FDA's OTC Monograph Problems
This article was originally published in The Pink Sheet
Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.
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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.
Executives from OTC drug manufacturers list numerous doubts about the equity and effectiveness of a potential program that would impose user fees on firms that make or market monograph drugs, the vast majority of nonprescription pharmaceutical products.