U.S. FDA Commissioner says agency seeks fast review of COVID-19 products

[June 11, 2020]  By Deena Beasley

(Reuters) - The U.S. 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 on Wednesday.

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 Inc's antiviral drug remdesivir.

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

"We are trying to get EUA (emergency use authorization) 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 leveling 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 U.S. coronavirus-related deaths have surpassed 112,000, the most in the world.

The commissioner, in his post since mid-December, also emphasized the FDA's need to incorporate "real-world evidence" into how it considers formal approval of COVID-19 products currently available only under EUAs.

"The agency needs a significant investment in our approach to real world evidence," Hahn said.

The FDA chief also said work needs to be done to prepare the country for future outbreaks, including reliable access to supplies of critical drugs and equipment.

"We must bring back domestic manufacturing for essential medical products," Hahn said.

(Reporting By Deena Beasley; editing by Diane Craft)

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