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Tue Oct 13, 2020, 05:51 PM

FDA faults quality control at Lilly plant making Trump-touted COVID drug

Source: Reuters

HEALTHCARE & PHARMA
OCTOBER 13, 2020 5:04 PM UPDATED AN HOUR AGO

Exclusive: FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine, Marisa Taylor
10 MIN READ

(Reuters) - U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as ďa cureĒ for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The presidentís push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmakerís bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. Thatís because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

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Read more: https://www.reuters.com/article/us-health-coronavirus-lilly-exclusive/exclusive-fda-faults-quality-control-at-lilly-plant-making-trump-touted-covid-drug-idUSKBN26Y30C

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