FDA Sketches NSURE Novel Switch Initiative In 2012
This article was originally published in The Tan Sheet
FDA clarified parameters for novel switches, 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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Allowing for post-market monitoring would incentivize sponsors to consider switches and generate data that could inform a decision about potential conditions for safe use “without applying potentially burdensome – and possibly unnecessary – conditions upfront,” Pinney Associates health care consultancy says.
The director of FDA’s Division of Nonprescription Clinical Evaluation advises firms to wait to submit Rx-to-OTC switch applications until the regulations are revised to allow for expanded conditions of safe nonprescription use.
Leaders at FDA’s drug center appear more closely aligned with the OTC industry than with medical professionals’ groups on consumer access to innovative switches. CDER Director Woodcock says the clinical community has resisted switches – and been proven wrong – before.