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

Exclusive: FDA faults quality control at Lilly plant making Trump-touted COVID drug (This Oct. 13 story corrects to show that the federal government, not Eli Lilly, made the decision to pause a clinical trial of the company’s antibody drug, paragraph 10) Dan Levine, Marisa Taylor U.S.

(Reuters) - U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co LLY.N pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” 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 REGN.O 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. ..

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 drugmaker’s bid for an EUA from the federal agency, two of the sources and two outside legal experts told Reuters. That’s 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.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show. ...