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Stephen Hahn, President Trump’s nominee to helm the Food and Drug Administration, will today face his first real test in Washington — a confirmation hearing packed with hours of questions from senators on nearly every aspect of the agency’s sprawling portfolio, from mysterious vaping illnesses to the promise of gene therapies.

Hahn, who currently serves as the chief medical executive of MD Anderson Cancer Center, is auditioning for the FDA’s top job at a transformational time for the agency.

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The FDA has faced widespread criticism from both lawmakers and public health advocates for its failure to stem the epidemic of youth vaping, even as the Trump White House has shied away from the hands-on approach championed by public health advocates and Hahn’s predecessor Scott Gottlieb. The agency is also being dragged into the bipartisan debate over how to lower the high costs of medical breakthroughs. And then there’s the opioid epidemic, the changing world of clinical trials, and gene therapies, too.

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  • I’ have been posting for several years that FDA has been totally unwilling to use its authority to regulate vaping device safety, impose nicotine purity and dosage levels, and make a gesture to ban the sale of devices designed for vaping illicit drugs. As a consequence we have seen needless illness and death – but only in the USA where we have “free markets” (an oxymoron if there ever was one).

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