FDA plots mul­ti-day hear­ing to re­view 'dan­gling' ac­cel­er­at­ed ap­proval that drug­mak­er re­fus­es to pull

What hap­pens when the FDA tells a com­pa­ny to pull a drug ap­proved un­der its ac­cel­er­at­ed path­way be­cause it didn’t prove to be ef­fec­tive in a con­fir­ma­to­ry tri­al, and the com­pa­ny re­fus­es?

That’s what is cur­rent­ly play­ing out be­tween the FDA and Co­vis Phar­ma, which will du­el it out dur­ing a fi­nal two-and-a-half-day vir­tu­al hear­ing set for next Sep­tem­ber or Oc­to­ber, ac­cord­ing to the lat­est let­ter from Celia Wit­ten, FDA’s di­rec­tor of the Of­fice of Cel­lu­lar, Tis­sue and Gene Ther­a­py and who’s pre­sid­ing over the hear­ing.

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