Top House Democrats have launched an investigation into whether Emergent Biosolutions, which recently messed up 15 million doses of Covid-19 vaccine, has won the federal contract to take the shots based on his cozy relationship with a former top US official. Trump administration.
Representatives Carolyn B. Maloney, of New York, chairman 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 the CEO of Emergent Solutions , Robert G. Kramer, and Executive Chairman, Fuad El-Hibri, to request that they testify before the Coronavirus Subcommittee.
“In particular, we are examining reports that Emergent has received multi-million dollar contracts to produce coronavirus vaccines despite a long, documented history of under-trained personnel and quality control issues,” the legislators wrote.
The committees look specifically at the role that Dr. Robert Kadlec, a former adviser to Emergent and Trump’s assistant secretary for preparedness and response, was instrumental in helping the company win the contract. They asked the company to hand over a slew of documents, including all of its federal contracts since 2015, all communications with Kadlec, as well as information on audits and inspections of its facilities, drug prices, and executive fees, among others.
“Emergent received $ 628 million in June 2020 to establish the premier US facility for the production of vaccines developed by Johnson & Johnson and AstraZeneca,” lawmakers wrote to Kramer and El-Hibri on a Monday. Kadlec “appears to have pushed for this award despite indications that Emergent was unable to reliably perform 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 Emergent’s plan to produce much-needed coronavirus vaccines was inadequate due to poorly trained staff and quality control issues.
Despite Emergent falling short of federal inspections, the Trump administration paid $ 628 million to the company in June to produce coronavirus vaccines.
Reports emerged later indicating quality control issues at the Baltimore factory in Emergent.
“During the manufacturing process, your company contaminated millions of doses of Johnson & Johnson’s one-time coronavirus vaccine with AstraZeneca vaccine ingredients,” wrote lawmakers.
Emergent was forced to destroy up to 15 million contaminated doses of the Johnson & Johnson vaccine, and an additional 62 million doses remained in limbo until it could be determined that they were unaffected by the confusion, they said, referring to reporting from The. New York Times.
The Baltimore plant in Emergent had not been approved by the Food and Drug Administration, so none of the doses produced at that location were ever distributed or ended up in the arms of the Americans.
“We are concerned about the cost to taxpayers and the potential impact on our country’s vaccination efforts as a result of Emergent’s failed attempts to produce these vaccines,” wrote lawmakers.
Lawmakers also said they are looking at Emergent’s role as the sole supplier of anthrax vaccines in the strategic national stockpile.
“Emergent has increased the government’s purchase price of the anthrax vaccine by 800% since the drug was purchased in 1998. As a result, for most of the past decade, nearly half of the SNS’s budget has been spent on purchasing the drug. Emergent anthrax vaccine, “said 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 stock “that were awarded without competing bids.”
Emergent encouraged oversight of the stock to be transferred from the Centers for Disease
Control and prevention to the office of the Deputy Secretary of Preparedness and Response, under the control of Kadlec, according to the letter.
Until 2015, Kadlec provided advisory services to Emergent through his company RPK Consulting. Kadlec was confirmed to lead the office, which is under 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.