FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA tout­ed a pro­ce­dure for Covid-19 meds that com­mit­ted the agency to im­me­di­ate ac­tion for de­vel­op­ers, for­mal­iz­ing a high-speed re­sponse that’s been promised for weeks.

Bioreg­num Opin­ion Col­umn by John Car­roll

De­ci­sions that once re­quired months would be mea­sured in hours un­der the Coro­n­avirus Treat­ment Ac­cel­er­a­tion Pro­gram. “In many cas­es” tri­al pro­to­cols could be ham­mered out in less than a sin­gle day. If you had a po­ten­tial so­lu­tion to the cri­sis, the ap­pro­pri­ate staffer would be in touch “to get stud­ies un­der­way quick­ly.”

It would be the ul­ti­mate high-speed reg­u­la­to­ry path­way from Phase I to ap­proval. Red tape was ban­ished.

But it’s clear that for some — and quite like­ly many — bio­phar­ma ex­ecs, the ac­tu­al agency re­sponse has not mea­sured up to the promise. Be­yond the front ranks of ad­vanced com­pa­nies in the field, like Gilead, or for drugs en­dorsed by Pres­i­dent Trump, it may not even come close.

“The first re­sponse is this form let­ter every­one gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top of­fi­cials to the front­line staff ac­tu­al­ly charged with get­ting things done.

Endpoints Premium

This article is available only to Premium subscribers

Upgrade to Premium for unlimited access and Premium exclusives.