FDA’s Regulatory Flexibility On Display In Review Of Innovative Agents
This article was originally published in Pharmaceutical Approvals Monthly
Regulatory flexibility is the backbone of FDA’s success in efficiently reviewing new drugs and biologics, especially on the frontiers of unmet medical needs, Pharmaceutical Approvals Monthly’s 2011 series of drug review profiles shows.
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GlaxoSmithKline’s Mekinist (trametinib) and Tafinlar (dabrafenib) qualified for the regulatory benefits afforded drugs that address unmet medical needs under a broad theory introduced in FDA’s draft guidance on expedited approval pathways: offering different, but not necessarily better, toxicity profiles than marketed drugs was seen as an advantage.
Novartis’ targeted combination strategy in particular leverages its “strong” pipeline in agents acting on the PI3K, RAS, RAF and MEK pathways.
A survey of well-informed voters conducted by the health policy institute NEHI found respondents were in favor of marketing products that might pose a risk, as long as FDA disclosed the potential dangers. Commissioner Hamburg says she is “pleased and frankly a little surprised” by the depth of appreciation for the agency’s work shown by the survey.