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Market Exclusivity Needed For Special Condition Switches – Expert

This article was originally published in The Tan Sheet

Executive Summary

Without market exclusivity and a requirement to make generics also subject to consumer access restrictions, drug firms likely will not invest in novel switches, says a switch process veteran and Merck Consumer Care executive.

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FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney

Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.

FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney

Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.

FDA Sketched NSURE Novel Switch Initiative In 2012

FDA clarified parameters for novel switches of drugs to OTC status, including protecting innovators from potentially unfair generic competition and stating that a behind-the-counter class is not being considered, but the year ended without clear signals on what could be the potential first novel switch candidate and when FDA expects to propose regulatory changes to facilitate switches under conditions of safe use.

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