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Exclusivity Provision Surfaces In OTC Monograph Bill

Executive Summary

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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Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

Legislators On OTC Monograph Reform: What Took You So Long?

"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.

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