Top House Democrats have launched an investigation into whether Emergent Biosolutions, which recently completed 15 million doses of Covid-19 vaccine, won the federal contract to make the shots based on its sociable relationship with a former Trump administration official. official.
Reps Carolyn B. Maloney, of New York, chair of the House Committee on Supervision and Reform, and James E. Clyburn, of South Carolina, chair of the select subcommittee on the Coronavirus crisis, wrote a joint letter to the CEO sent from Emergent Solutions. , Robert G. Kramer, and executive chairman, Fuad El-Hibri, to request that they testify before the coronavirus subcommittee.
“We are specifically investigating reports that Emergent has received multi-million dollar contracts to manufacture coronavirus vaccines, despite a long, documented history of inadequately trained personnel and quality control issues,” the lawmakers wrote.
The committees look specifically at the role that dr. Robert Kadlec, a former consultant to Emergent and Trump’s assistant secretary for preparedness and response, played to help the company win the contract. They asked the company to provide a series of documents, including all its federal contracts since 2015, all communications with Kadlec, as well as information on audits and inspections of its facilities, drug prices and remuneration for executives, among others.
“Emergent received $ 628 million in June 2020 to establish the primary U.S. 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 appealed against this award, despite indications that Emergent did not have the capacity to honorably 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 staff to produce a coronavirus vaccine. Another inspection, in June, found that Emergent’s plan to produce the much-needed coronavirus vaccines was inadequate due to poorly trained staff and quality control issues.
Despite the fact that Emergent falls short of 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 Emergent’s Baltimore plant.
“During the manufacturing process, your company contaminated millions of doses of Johnson & Johnson’s single-suspension coronavirus vaccine with ingredients from the AstraZeneca vaccine,” the lawmakers wrote.
Emergent was forced to destroy up to 15 million infected doses of the Johnson & Johnson vaccine, and another 62 million doses remained in limbo until it could be determined that it was not affected by the mixture. York Times.
Emergent’s Baltimore plant was not approved by the Food and Drug Administration, and none of the doses produced on that site were ever distributed or brought into Americans’ arms.
“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 manufacture these vaccines,” the legislators wrote.
The legislators also said they were looking at the role of Emergent as the country’s sole provider of anthrax vaccine in the Strategic National Stock.
“Emergent has increased the purchase price of the anthrax vaccine by 800% since the acquisition of the drug in 1998. As a result, almost half of the SNS’s budget has been spent on Emergent’s anthrax vaccine for most of the past decade. for sale, “the representatives said. 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 “awarded without a competitive bid.”
Emergent encouraged inventory oversight to be transferred from the Centers for Disease
Control and prevention at the office of the Assistant Secretary of Preparedness and Response, under Kadlec’s control, according to the letter.
Until 2015, Kadlec provided advisory services to Emergent through its company, RPK Consulting. Kadlec has been confirmed that he will head 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.