Automatic three-year exclusivity for Rx-to-OTC switches urged by NDMA.
This article was originally published in The Tan Sheet
Executive Summary
Rx-TO-OTC SWITCHES AUTOMATIC THREE-YEAR EXCLUSIVITY URGED BY NDMA in written comments to the April 11 Senate Labor & Human Resources Committee hearing on FDA reform ("The Tan Sheet" April 14, p. 15). Among its requests, the Nonprescription Drug Manufacturers Association asks for a congressional "declaration that the grant of three-year exclusivity in current law shall be the general rule for applications to switch a drug from prescription to nonprescription status, to ensure the continued vitality of the important OTC switch movement."
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