US FDA seeks fast review of COVID-19 products: Commissioner Stephen Hahn

The US Food and Drug Administration is seeking to review treatments and tests for COVID-19 “as fast as we can” for emergency clearance, with the priority on those using high-level science, the agency’s commissioner said.

The FDA aims to expedite products with the greatest chance of making it through the clinical trial process and eventually helping people, FDA Commissioner Stephen Hahn said during a conference held by the Biotechnology Innovation Organization.

Since the onset of the COVID-19 pandemic earlier this year, the FDA has issued a series of temporary emergency approvals ranging from diagnostic tests to treatments such as Gilead Sciences’ antiviral drug remdesivir.

But the agency has faced criticism over decisions on potential treatments like hydroxychloroquine, which have become highly politicised.

“We are trying to get EUA (emergency use authorisation) applications and INDs (investigational new drug applications) out the door as fast as we can,” Hahn said in a moderated session conducted remotely and recorded for conference participants. “We are agnostic with respect to the sponsor, but we are very much aligned with where, to us, the science appears to be the highest level.”

The summer will likely see a levelling off of COVID-19 cases, but an uptick is expected in the fall – at the same time the influenza season typically begins, Hahn said.

Total US coronavirus-related deaths have surpassed 112,000, the most in the world.

The commissioner, in his post since mid-December, also emphasised on FDA’s need to incorporate “real-world evidence” into how it considers formal approval of COVID-19 products currently available only under EUAs.