martes, 28 de julio de 2020

It's not every day the Trump administration defends the FDA's safety standards

D.C. Diagnosis
Nicholas Florko

It's not every day the Trump administration defends the FDA's safety standards

On Monday, the Trump administration launched a full court press celebrating progress made by industry developing a coronavirus vaccine. President Trump toured a manufacturing facility in North Carolina along with HHS Secretary Alex Azar, while Vice President Mike Pence visited a clinical trial site in Miami with FDA Commissioner Stephen Hahn. 
Much of the hype centered around the start of Moderna’s Phase 3 clinical trial for its Covid-19 vaccine candidate. The fanfare isn’t surprising, given Trump’s reelection prospects seem increasingly  dependent on some progress in combating Covid-19. But what was notable was the Trump administration’s repeated insistence that the FDA won’t lower its standards to approve a coronavirus vaccine. 
In their public appearances Monday, multiple government officials repeatedly defended the FDA’s stringent safety standards. 
Pence and Hahn used their remarks at the University of Miami, for example, to insist that the administration was not cutting corners. On a press call Monday marking the start of the Moderna trial, NIH Director Francis Collins struck a similar tone. 
“While this is called Warp Speed and this has moved at a pace that’s unprecedented, nothing is being done here to compromise the safety of this particular trial or others like it, nor will we compromise on an ultimate conclusion about whether the vaccine is effective,” Collins said.”Those issues are going to be tested in the most rigorous way." 

Even President Trump — who has repeatedly pushed the FDA to go faster and has called for patients to have access to potentially unsafe drugs — defended the agency’s so-called "gold standard for safety.” 
While it’s too early to tell whether Trump has a newfound appreciation for the FDA’s approval criteria, it was a striking shift amid fears that the FDA would be forced to bend to Trump’s political will by approving a potentially unsafe or ineffective vaccine.

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