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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

DC faults White House over Rose Garden event, urges testing

WASHINGTON (AP) — In an extraordinary step, the Washington, D.C., Department of Health has released an open letter appealing to all White House staff and anyone who attended a Sept. 26 event in the Rose Garden to seek medical advice and take a COVID-19 test.

The letter indicates a lack of confidence in the White House medical team’s own contact tracing efforts regarding an ongoing virus outbreak that has infected President Donald Trump, multiple senior staff members and two U.S. senators, among others.

Co-signed by nine other local health departments from neighboring jurisdictions in Maryland and Virginia, the letter flatly states a belief that contact tracing on the outbreak has been insufficient.


It says the public appeal is based on, “our preliminary understanding that there has been limited contact tracing performed to date, there may be other staff and residents at risk for exposure to COVID positive individuals.”

It asks all White House employees, anyone who attended the Sept. 26 event and anyone who may have been in contact with those people to “contact your local health department for further guidance/questions regarding your potential need to quarantine.”

The letter represents a rising level of concern and a clear shift in strategy by Mayor Muriel Bowser’s government, which had previously remained publicly hands-off and said it trusted the White House’s robust medical operation to handle its own contact tracing and follow-up.

Bowser said earlier this week that repeated attempts to contact the White House over the outbreak had received a “very cursory” response but that she believed the necessary steps were being taken.

“There are established public health protocols at the White House that are federal in nature,” Bowser said on Monday. “We assume that those protocols have been engaged.”

A Health Department spokeswoman did not respond to questions on whether the letter had been directly sent to any White House employees or people who attended the Sept. 26 event, or if the D.C. government had been provided with a list of attendees.

The move highlights the public health dilemma faced by Bowser’s government regarding the current outbreak. The Trump White House has operated for months in open violation of several D.C. virus regulations, hosting multiple gatherings that exceeded the local 50-person limit and in which many participants didn’t wear masks.

It shines a further spotlight on the Sept. 26 Rose Garden ceremony to introduce Trump’s Supreme Court nominee, Amy Coney Barrett. Multiple attendees, including Trump and Notre Dame University President Rev. John Jenkins, who flew in from Indiana for the ceremony, have now tested positive.

Washington’s local virus regulations don’t apply on federal property, but the current outbreak has blurred those distinctions. Trump inner-circle members like former counselor Kellyanne Conway, who has also tested positive, are D.C. residents, as are many of the staffers, employees, Secret Service members and journalists who have had close contact with infected officials.

White House spokesman Judd Deere said Monday that the White House “has established a robust contact tracing program led by the White