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FDA Sketched NSURE Novel Switch Initiative In 2012

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Combination Products Offer Regulatory Option For Novel Switches

A novel switch application comprising a drug and a device would be “a classic combination product” and FDA has a framework for evaluation, says Bradley Merrill Thompson, an attorney who focuses on medical device law.

Market Exclusivity Needed For Special Condition Switches – Expert

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.

Experts Support Statin, Triptan, Sleep Aid Switches In New Paradigm

The American Society of Health-System Pharmacists has opposed allowing OTC sales of statins, but would support a switch made with conditions of safe use required. A Philadelphia College of Pharmacy professor argues that patients are better served by obtaining pharmaceuticals from health care professionals than using “un-standardized” dietary supplements

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