Emergent to testify before subcommittee on manufacturing mishaps

Two execs from Emergent BioSolutions will be in the Congressional hot seat next week.

As part of a government probe into the CDMO’s handling of COVID-19-related manufacturing, the Select Subcommittee on the Coronavirus Crisis has asked the company’s CEO, Robert Kramer, and its executive chairman, Fuad El-Hibri, to answer questions related to its “vaccine failures.”

Emergent’s challenges came to light early this spring when it became public that a manufacturing mistake at the company’s Bayview facility forced the company — which was awarded a $628 million contract from the government as part of Operation Warp Speed — to toss millions of J&J vaccine doses.

Afterwards, Emergent was asked to pause production and in late April, received a 12-page Form 483 from the FDA with a list of quality observations the company will have to resolve before it can begin manufacturing again.

“The hearing will examine how Emergent’s failure to maintain its manufacturing facilities, train its staff, and comply with Food and Drug Administration standards led to the destruction of millions of doses of coronavirus vaccines, including up to 15 million doses of the Johnson & Johnson vaccine, and how these failures may impact vaccination efforts,” the subcommittee said in a statement. 

Emergent has also taken heat for its aggressive lobbying for government contracts, particularly in relation to the Strategic National Stockpile — an issue that the subcommittee plans to discuss.   

“The hearing will also address how Emergent used its political connections to acquire lucrative manufacturing contracts and significantly raised its prices to the federal government in the years before the pandemic. These practices, which coincided with increased shareholder profits and executive pay, contributed to shortages of critical supplies in the early months of the coronavirus pandemic,” the subcommittee said. 

The subcommittee hearing is scheduled for Wednesday, May 19.