Exclusivity Provision Surfaces In OTC Monograph Bill
This article was originally published in The Pink Sheet
The House Health subcommittee asks whether allowing manufacturers' periods of US market exclusivity for some approved OTC monograph proposals is needed, or would be fair to consumers.
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"If the system is broken … my gosh, does it take 45 years for the FDA to say, 'we need help'?" US Rep. Joe Barton, R-TX, asks at House health subcommittee hearing on proposal to streamline the OTC monograph program and establish a user fee program to support FDA's work.
The beauty industry do-gooder returned to Washington Sept. 12 with 15 other brands in tow, pressing lawmakers for a hearing on the proposed Personal Care Products Safety Act.
One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.