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

By Dan Levine and Marisa Taylor

(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 “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 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 president’s 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 drugmaker’s bid for a so-called emergency use authorization (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.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

About 200 workers infected with coronavirus at MOL’s new Hungarian plant

BUDAPEST (Reuters) – About 200 workers have been infected with coronavirus at Hungarian energy group MOL’s <MOLB.BU> polyol plant being built in the eastern town of Tiszaujvaros, MOL’s petrochemicals unit wrote in a letter to the town’s mayor.

A press official for MOL confirmed the authenticity of the letter, dated Oct. 5 and published by the mayor on Facebook.

The letter said the 200 infected workers have been quarantined and had no symptoms. MOL said work at the construction site was ongoing with reduced staff levels.

The $1.3 billion plant, built by Germany’s ThyssenKrupp <TKAG.DE>, will make MOL the only integrated producer of polyether polyols in Central and Eastern Europe.

The compounds are needed for products in the automotive, construction, packaging and furniture industries.

MOL said in the letter it was testing its blue-collar staff for coronavirus every two to three weeks and expected to test all white-collar workers by the end of this month. MOL said it expected subcontractors to test their staff as well.

As of Tuesday, Hungary reported 32,298 coronavirus cases with 853 deaths and 8,723 recoveries. New cases have spiked in the past weeks and the 20 deaths registered on Tuesday were the highest since the start of the pandemic.

(Reporting by Gergely Szakacs; Editing by Tomasz Janowski)

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U.S. government tried to “intimidate” California county health department to keep poultry plant open after COVID deaths, director says

There have reportedly been tens of thousands of coronavirus cases at meat and poultry plants. More than 44,000 workers nationwide have tested positive for the virus, and more than 200 have died, according to the Food & Environment Reporting Network, an investigative nonprofit.

In late April, President Trump issued an executive order urging plants to stay open. Since then, CBS News has only been able to identify a couple of plants that were temporarily closed by government agencies due to COVID-19 outbreaks. One is the Foster Farms poultry plant in California’s Merced County.

Despite what it says was political pressure, the small county’s health department closed down the plant in Livingston for one week due to a COVID-19 outbreak that claimed some workers’ lives. 

One of those workers was Perla Meza’s 61-year-old father Filiberto, who she says worked unloading trucks at Foster Farms for years until he came down with COVID-19. 

“He was in quarantine for three days when everything got worse,” Meza said. 

In August, he went to the hospital and then into a coma for three days, Meza said. He later died.  

Some 2,600 people work at the plant. Merced County public health officials declared an outbreak there in late June, and during a visit, recommended Foster Farms test all of its workers, said department director Rebecca Nanyonjo-Kemp.

“You need to conduct universal screening of all of your staff. You have way too many staff here to be able to control one factor. You’re being controlled by the factors because you have so many people here,” Nanyonjo-Kemp said. “Don’t let your illness take over your facility.”

The plant said they would listen to the advice, Nanyonjo-Kemp said.

“Unfortunately, that did not materialize,” she told CBS News consumer investigative correspondent Anna Werner.

Only limited testing occurred, she said. In July, two workers died of COVID-19.  

The county continued to monitor the outbreak, and on August 7, Foster Farms provided a list showing the number of workers actively infected and those whose cases they described as “resolved.”

But county health officer Dr. Salvador Sandoval noticed the list contained no deaths, even though county health staff said workers had told them there were more.

So the health department emailed Foster Farms to ask if there were “any known deaths,” and the next week, received a new list. This time, Sandoval said, five names previously listed only as “resolved” were now listed as “deaths.”

The company put the names “in a category that made it difficult for our investigators to tag them as being people who had died,” Sandoval said.

He described what the company did as “misleading.” “I feel it’s wrong,” he said.

The company told CBS News, “There was no intentional effort on the part of Foster Farms to deceive the Merced (County) Public Health Department,” and said, “All issues related to the reporting of data were quickly resolved.”

But late in August, with eight deaths and over 350 confirmed cases, county health officials told Foster Farms the plant would