Top House Democrats have launched an investigation into whether Emergent Biosolutions, which recently eliminated 15 million doses of Covid-19 vaccine, won the federal photo contract based on its comfortable relationship with a former Trump administration top official. .
Representatives Carolyn B. Maloney of New York, chair of the House Oversight and Reform Committee, and James E. Clyburn of South Carolina, chair of the subcommittee selected for the coronavirus crisis, sent a joint letter to Emergent Solutions CEO Robert G Kramer and Executive Chairman Fuad El-Hibri to testify before the coronavirus subcommittee.
“Specifically, we are investigating reports that Emergent has received multi-million dollar contracts for the manufacture of coronavirus vaccines, despite a long and documented history of inadequately trained staff and quality control issues,” the lawmakers wrote.
The committees specifically look at the role that Dr. Robert Kadlec, a former Emergent consultant and Secretary of Trump’s assistant for training and response, has played to help the company win the contract. They asked the company to hand over a number of documents, including all its federal contracts since 2015, all communications with Kadlec, as well as information about audits and inspections of its facilities, drug pricing and executive compensation, among others.
“Emergent received $ 628 million in June 2020 to set up the main vaccine manufacturing unit developed by Johnson & Johnson and AstraZeneca,” lawmakers wrote in a letter Monday to Kramer and El-Hibri. Kadlec “appears to have pressed for this award, despite indications that Emergent did not have the capacity to perform the contract reliably”.
According to the letter, an FDA inspection of the Baltimore plant in April 2020 showed that Emergent did not have the necessary staff to produce a coronavirus vaccine. Another inspection in June found that the Emergent Plan for the production of vaccines in desperate need of coronavirus was inadequate due to poorly trained staff and quality control problems.
Despite the fact that Emergent failed federal inspections, the Trump administration paid the company $ 628 million in June to make coronavirus vaccines.
Subsequently, reports appeared indicating quality control problems at the emerging Baltimore plant.
“During the manufacturing process, your company contaminated millions of doses of Johnson & Johnson unique coronavirus vaccine with AstraZeneca vaccine ingredients,” the lawmakers wrote.
Emergent was forced to destroy up to 15 million contaminated doses of Johnson & Johnson vaccine and another 62 million doses remained in the tongue until it could be determined they were not affected by the mixture, they said, citing reports The New York Times.
Emergent’s Baltimore plant was not approved by the Food and Drug Administration, so none of the doses produced there were distributed or made its way into the arms of the Americans.
“We are concerned about 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.
MPs also said they were looking at Emergent’s role as the sole national provider of anthrax vaccine in the strategic national stock.
“Emergent has raised the government’s purchase price for the anthrax vaccine by 800% since purchasing the drug in 1998. As a result, for most of the last decade, almost half of the NHS budget has been spent on the purchase of the Emergent anthrax vaccine,” 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 stock contracts “that were awarded without competitive bidding.”
The emergency encouraged stock surveillance to be transferred from the Centers for Disease
Control and prevention to the office of the assistant secretary of training and response, under the control of Kadlec, according to the letter.
Until 2015, Kadlec provided consulting services to Emergent through its company, RPK Consulting. Kadlec was confirmed to lead the office, which is part of 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 ET.