Angered by NIH’s Collins, Trump misfires and hits FDA Commissioner Hahn
Concerns about pace of trial enrollment for COVID-19 mAbs cause president to lash out
President Donald Trump’s recent attacks on FDA were prompted by Trump’s anger at NIH Director Francis Collins for delaying authorization of COVID-19 convalescent plasma, individuals who have been in close touch with the White House told BioCentury. Trump’s misunderstandings about the roles of FDA and NIH, and concerns about the pace of clinical trial enrollment for COVID-19 mAb candidates, caused the president to lash out at FDA and its commissioner, Stephen Hahn, rather than Collins.
FDA was poised to issue an Emergency Use Authorization (EUA) last week for COVID-19 convalescent plasma. It put the plans on hold after Collins objected, citing a lack of data from randomized, controlled trials. NIH has no formal role in FDA’s regulatory decisions and the agency has in the past disregarded his concerns...