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 for inclusion because of its cozy relationship with a former top Trump government official.
New York Rep. Carolyn B. Maloney, Chair of the House Committee on Oversight and Reform, and James E. Clyburn of South Carolina, Chair of the Select Subcommittee on Coronavirus Crisis, sent a joint letter to Emergent Solutions CEO Robert G. Kramer and board chairman Fuad El-Hibri demand that they testify before the coronavirus subcommittee.
“In particular, we are investigating reports that Emergent has won multi-million dollar contracts to manufacture coronavirus vaccines, despite a long, documented history of inadequately trained personnel and quality control issues,” the legislature wrote.
The committees deal specifically with the role that Dr. Robert Kadlec, former Emergent Advisor and Trump’s Assistant Secretary for Preparedness and Response, has played in helping the company get the job done. They asked the company to hand over a number of documents, including all federal contracts since 2015, all communications with Kadlec, as well as information on audits and inspections of its facilities, drug pricing and executive compensation.
“Emergent received $ 628 million in June 2020 to set up the primary US vaccine manufacturing facility developed by Johnson & Johnson and AstraZeneca,” lawmakers wrote in a letter sent to Kramer and El-Hibri on Monday . Kadlec “appears to have pushed for this award, although there are 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 personnel to manufacture a coronavirus vaccine. Another inspection in June revealed that Emergent’s plan to manufacture much-needed coronavirus vaccines was inadequate due to poorly trained staff and quality control issues.
Despite falling short on federal inspections, the Trump administration paid the company $ 628 million in June to manufacture coronavirus vaccines.
Reports later surfaced indicating quality control issues at Emergent’s Baltimore facility.
“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 legislature wrote.
Emergent was forced to destroy up to 15 million tainted doses of the Johnson & Johnson vaccine, and an additional 62 million doses remained pending until it was found not to have been mistaken by the York Times.
Emergent’s Baltimore facility has not been approved by the Food and Drug Administration, so none of the cans produced at the site were ever distributed or made it into the arms of the Americans.
“We are concerned about the cost to taxpayers and the potential impact on our country’s vaccination efforts from failed attempts by Emergent to manufacture these vaccines,” the legislature wrote.
Lawmakers also said they are considering Emergent’s role as the sole anthrax vaccine supplier on the Strategic National Stockpile.
“Emergent has increased the government purchase price for the anthrax vaccine by 800% since the drug was purchased in 1998. As a result, nearly half of the SNS budget has been spent on purchasing Emergent’s anthrax vaccine over the past decade,” so the representative 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 inventory contracts, “which were put out to tender”.
Emergent encouraged oversight of the inventory to be transferred from the Centers for Disease
Control and Prevention to the Deputy Secretary’s Office for Preparedness and Response under Kadlec’s control according to the letter.
Until 2015, Kadlec Emergent advised through his company RPK Consulting. Kadlec was confirmed as the head of the Office of the Ministry of Health and Human Services in 2017.
Kramer and El-Hibri were asked to testify before the subcommittee on May 19 at 10:30 am ET.