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Sunday, May 09, 2021

Congressional investigation launched into Emergent BioSolutions' federal vaccine contracts

Congressional investigation launched into Emergent BioSolutions' federal vaccine contracts

Congressional investigators have requested top executives from Emergent BioSolutions testify before the Select Subcommittee.
Top House Democrats have launched an investigation into whether Emergent Biosolutions, which recently botched 15 million doses of Covid-19 vaccine, won the federal contract to make the shots based on its cozy relationship with a top former Trump administration official.

Reps. Carolyn B. Maloney, of New York, chairwoman of the House Committee on Oversight and Reform, and James E. Clyburn, of South Carolina, chairman of the Select Subcommittee on the Coronavirus Crisis, sent a joint letter to Emergent Solutions’ CEO, Robert G. Kramer, and executive chairman, Fuad El-Hibri, to request that they testify before the coronavirus subcommittee.

“Specifically, we are investigating reports that Emergent received multi-million-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues,” the lawmakers wrote.

The committees are specifically looking at the role Dr. Robert Kadlec, a former consultant to Emergent and Trump’s assistant secretary for preparedness and response, played in helping the company win the contract. They asked the company to turn over a slew of documents, including all of its federal contracts since 2015, all communication with Kadlec as well as information on audits and inspections of its facilities, drug pricing and executive compensation, among other things.

“Emergent received $628 million in June 2020 to establish the primary U.S. facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca,” the lawmakers wrote in a letter sent Monday to Kramer and El-Hibri. Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

According to the letter, an FDA inspection of the Baltimore plant in April 2020 revealed that Emergent did not have the necessary personnel to produce a coronavirus vaccine. Another inspection, in June, found that Emergent’s plan for producing desperately needed coronavirus vaccines was inadequate due to poorly trained staff and quality control problems.

Despite Emergent falling short on federal inspections, the Trump administration paid $628 million to the company in June to manufacture coronavirus vaccines.

Reports later emerged that indicated quality control issues at Emergent’s Baltimore plant.

“During the manufacturing process, your company contaminated millions of doses of Johnson & Johnson’s one-shot coronavirus vaccine with ingredients from the AstraZeneca vaccine,” the lawmakers wrote.

Emergent was forced to destroy up to 15 million tainted doses of the Johnson & Johnson vaccine, and another 62 million doses remained in limbo until it could be determined that they were not affected by the mix-up, they said, citing reporting by The New York Times.

Emergent’s Baltimore plant wasn’t approved by the Food and Drug Administration, so none of the doses produced at that site were ever distributed or made their way into Americans’ arms.

“We are concerned by the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by Emergent’s failed attempts to manufacture these vaccines,” the lawmakers wrote.

The lawmakers also said they are looking at Emergent’s role as the nation’s sole provider of anthrax vaccine in the Strategic National Stockpile.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998. As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine,” the representatives wrote.

According to the letter, after Kadlec was confirmed in the Trump administration, Emergent received millions of dollars in federal contracts from his agency, including contracts for the stockpile “that were awarded without competitive bidding.”

Emergent encouraged oversight of the stockpile to be transferred from the Centers for Disease
Control and Prevention to the Office of the Assistant Secretary of Preparedness and Response, under Kadlec’s control, according to the letter.

Until 2015, Kadlec provided consulting services to Emergent through his company, RPK Consulting. Kadlec was confirmed to lead the office, which is within the Department of Health and Human Services, in 2017.

Kramer and El-Hibri were asked to testify before the subcommittee on May 19 at 10:30 a.m. ET.
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