Hydroxychloroquine EUA Is First Rx Victim Of Hahn’s ‘Move Fast, Course Correct’ Philosophy
US FDA's decision to revoke the COVID-19 emergency use authorization for two anti-malarial drugs keeps with commissioner Hahn's stated goal of moving fast to tackle the pandemic, but shifting course as new data comes available. FDA cited new evidence as well as a reanalysis of the data it initially based the EUA on as reasons for pulling the authorization. Meanwhile, HHS Secretary Alex Azar appeared to equate the EUA revocation as opening the doors for broader use of the medicine, potentially undermining FDA's own communication on the drug, in yet another example of political leaders complicating the science and public health response to COVID-19.
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When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science.
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.