Emergent BioSolutions scored more than $1 billion in COVID-19 manufacturing contracts last year, but production issues at its Baltimore plant have placed the company under an intense spotlight in recent weeks. Now, lawmakers are launching a probe into its production deals and recent manufacturing missteps.
The House Oversight Committee has launched an investigation into Emergent's $628 million federal contract to produce COVID-19 vaccines for Johnson & Johnson and AstraZeneca. Specifically, the committee will look at the company's influence within the Trump administration, and its “documented history” of quality control issues and contractual missteps, the announcement said.
In addition to the $628 million from the government, Emergent scored hundreds of millions from its partners AstraZeneca and J&J.
The probe comes amid a tough stretch for Emergent, which recently had to scrap up to 15 million doses of J&J’s vaccine over an ingredient mix-up at its Baltimore plant. The feds stepped in to put J&J in charge of production there, but on Monday, the FDA and Emergent agreed to halt manufacturing at the Baltimore facility altogether.
Meanwhile, a separate instance of suspected contamination forced workers at the plant to destroy “millions” of AstraZeneca doses between October and January, the Oversight Committee claims.
“We welcome the opportunity to answer the committees’ questions and to discuss our important work supporting the nation’s public health preparedness and response,” an Emergent spokesperson said via email.
The investigation will focus in part on Robert Kadlec, M.D., who worked as a consultant to Emergent until 2015. In 2017, former President Donald Trump nominated Kadlec to head up the Office of the Assistant Secretary for Preparedness and Response (ASPR). In the wake of his confirmation, Emergent received “millions of dollars” in ASPR contracts, including contracts for the Strategic National Stockpile that were awarded without competitive bidding, the Oversight Committee claims.
Kadlec appears to have pushed for Emergent’s $628 million contract to produce COVID-19 vaccines, too, “despite indications that Emergent did not have the ability to reliably fulfill the contract," the House committee says.
An FDA inspection of the Baltimore plant last April, which came just two months before Emergent won its contract, showed the company lacked necessary personnel to produce a coronavirus vaccine. Another inspection in June raised additional concerns about poorly trained staff and quality control shortfalls.
Meanwhile, the Oversight Committee alleges the government’s stockpile spending on Emergent’s anthrax vaccine contributed to shortages of critical pandemic supplies like ventilators, reusable respiratory masks and other personal protective equipment, thanks to the contractor's "outsized influence over the price and procurement" of its shot.
Emergent is the sole supplier of the anthrax vaccine to the Strategic National Stockpile and has raised the government purchasing price on the shot by 800% since acquiring the drug in 1998, the committee said. Last year, the U.S. spent more than $370 million on the vaccine.
RELATED: Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light
In light of the concerns, the committee asked Emergent CEO Robert Kramer and Executive Chairman Fuad El-Hibri to testify before the House Select Subcommittee on the Coronavirus Crisis on May 19.
Just as headlines about the congressional probe began to emerge, the contract manufacturer faced a fresh round of scrutiny on Wednesday. After a plant inspection that wrapped up Tuesday, the FDA publicly laid out a range of quality control and cleanliness issues its staff discovered. Aside from paint chipping off walls and employees toting unsealed bags of medical waste through the facility, investigators said Emergent had failed to properly look into the drug substance mix-up that ruined the batch of J&J vaccines.
Even more concerning, “[t]here is no assurance that other batches have not been subject to cross-contamination,” the FDA said in its report.
Still, with J&J's added manufacturing expertise, Emergent should be able to address the regulator's concerns, Cantor Fitzgerald analysts wrote in a note to clients Wednesday.
But the FDA's concerns about the size of the plant and the equipment there "will probably give the Congressional investigation … some legs," the analysts wrote. Capacity problems are tricky to solve in a timely manner, the analysts noted. But the production of AstraZeneca's vaccine has already ramped down at the plant, which "goes a long way to alleviating some capacity constraints," they noted.