Lillyhitbystaff accusations, FDA scrutiny at Covid-19 drug factories

Eli Lilly & Co (LLY.N) employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the US plant producing the drugmaker’s Covid-19 treatment, according to an internal Lilly complaint and a source familiar with the matter.

The unsigned report, filed April 8 in Lilly’s confidential employee complaint system and reviewed by Reuters, is the latest sign of manufacturing problems at the drug giant. The complaint asserts that the executive, a top quality official at the company’s factory in Branchburg, New Jersey, rewrote findings by Lilly technical experts at the plant, which has been under investigation by the U.S. Food and Drug Administration, to make the conclusions appear more favorable to the company.

The source, who spoke on condition of anonymity, said the findings involved the production of drugs including Lilly’s Covid-19 therapy, whose use in the United States is funded by the federal government. The coronavirus antibody treatment, bamlanivimab, has been authorized by the FDA for emergency use in combination with a second Lilly drug for mild to moderate infections in people at high risk of severe illness.

Separately, FDA inspectors in March identified numerous manufacturing lapses at a second Lilly facility in Indianapolis that bottles the Covid-19 therapy and other drugs. The problems included substandard sanitation and quality control procedures, according to a preliminary FDA inspection report released to Reuters under open records laws. The Indianapolis inspection findings have not been previously reported.