Top House Democrats have launched an investigation into whether Emerging Biosolutions, which recently eliminated 15 million doses of Covid-19 vaccine, won the federal contract to make the shootings based on its welcoming relationship with a senior official of the Trump administration.
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 Select Subcommittee on the Coronavirus Crisis, sent a joint letter to the CEO. of Emerging Solutions, Robert G. Kramer, and Executive Chairman Fuad El-Hibri, to ask them to 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,” lawmakers wrote.
The committees are specifically studying the role played by Dr. Robert Kadlec, a former Emerging consultant and Trump’s deputy secretary for preparation and response, to help the company win the contract. They asked the company to deliver a large number 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, the price of drugs, and compensation for executives, among other things.
“Emergent received $ 628 million in June 2020 to establish the leading U.S. vaccine manufacturing facility developed by Johnson & Johnson and AstraZeneca,” 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 inspection by the FDA’s Baltimore plant in April 2020 revealed that Emergent did not have the staff to produce a coronavirus vaccine. Another inspection, in June, found that Emergent’s plan to produce desperately needed coronavirus vaccines was inadequate due to poorly trained staff and quality control issues.
Although Emergent failed to get federal inspections, the Trump administration paid $ 628 million to the company in June to manufacture coronavirus vaccines.
Reports later emerged indicating quality control issues at the Emergent plant in Baltimore.
“During the manufacturing process, your company contaminated millions of doses of Johnson & Johnson’s unique coronavirus vaccine with AstraZeneca vaccine ingredients,” the lawmakers wrote.
Emergent was forced to destroy up to 15 million contaminated 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 confusion, they said. , citing reports from The New York Times.
The Baltimore Emerging plant was not approved by the Food and Drug Administration, so none of the doses produced at that site were distributed or reached American arms.
“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,” lawmakers wrote.
Lawmakers also said they were studying the role of Emergent as the sole national provider of anthrax vaccines in the national strategic stock.
“Emergent has raised the government’s purchase price of the anthrax vaccine by 800% since it acquired the drug in 1998. As a result, for most of the last decade, nearly half of the NHS’s budget has been has been dedicated to buying Emergent’s anthrax vaccine, ”representatives wrote.
According to the letter, after Kadlec’s confirmation to the Trump administration, Emergent received millions of dollars in federal contracts from his agency, including contracts for the reservation “that were awarded without competitive bidding.”
Emergents encouraged supervision of the reserve to transfer it from disease centers
Control and prevention in the office of the Deputy Secretary of Preparation and Response, under the control of Kadlec, according to the letter.
Until 2015, Kadlec provided consulting services to Emergent through its company, RPK Consulting. It was confirmed that Kadlec would head the office, which is located 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.