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Regulatory Focus™ > News Articles > 2021 > 5 > Legislators blast Emergent officials at House hearing

Legislators blast Emergent officials at House hearing

Posted 19 May 2021 | By Joanne S. Eglovitch 

Legislators blast Emergent officials at House hearing

Emergent CEO Robert G. Kramer

Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.

The House Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC) along with the House Committee on Oversight and Reform heard testimony from Robert Kramer, president and chief executive officer of Emergent BioSolutions, and Fuad El-Hibri, the company’s executive chairman of the board.

Last year, the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) awarded a $628 million contract to the company to produce COVID-19 vaccine candidates through 2021. The company was subsequently contracted by Johnson & Johnson and AstraZeneca to manufacture their vaccines.

“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,” Clyburn and Rep. Carolyn Maloney (D-NY), chair of the oversight and reform committee, said in a joint statement.

Rep. Maloney noted that Kramer received $5.7 million in total compensation in 2020, yet “you have yet to give this country one vaccine.”

In April, the company was forced to destroy 15 million doses of the Johnson & Johnson COVID-19 vaccine due to a mix-up of ingredients and had to pause new production as it addressed quality issues at the plant (RELATED: FDA finds mess of sterility problems at Emergent, Regulatory Focus 21 April). At the plant, investigators found peeling paint on the warehouse floor and a warehouse that was overcrowded with materials staged for entry into manufacturing and quality control sampling.

Legislators slammed Emergent’s leaders for inadequate facility maintenance and not taking seriously problems identified in an earlier inspection, as well as a lackadaisical approach to employee training.

“This product was contaminated because the facility was dirty, it was not clean and could not do the work it was supposed to do…. This problem cannot be swept under the rug,” Rep. Maxine Waters (D-CA) said.  

While Emergent’s leadership say they “care about quality control and training” more money is spent on compensating employees and on lobbying efforts, Rep. Bill Foster (D-IL) said. He noted that a June 2020 inspection by auditors for Johnson & Johnson found mold and brown residue on the walls, yet the problem was not resolved and 10 months later the building was used to make the vaccine.

Kramer defended his company, pointing out that it was tasked with an unprecedented job of scaling up a vaccine to make millions of doses in a very short time.

“We were asked to very quickly to do tech transfer on these two candidates and scale them up and make hundreds of millions of doses of vaccines. This process usually takes one to two years and we were asked to do that in a period of months,” he said.
He added that the company had to throw out scores of AstraZeneca doses because “we were working at an unprecedented pace.”
Prior to the hearing, Rep. Clyburn and Rep. Maloney also released a memo prepared by committee staff members on their investigations into Emergent.
“The Committees’ investigation raises troubling new questions about the lucrative contract Emergent received under the Trump Administration, the company’s failure to address manufacturing problems that led to the decision of millions of desperately needed coronavirus vaccines, and large bonuses paid to top executives s despite these failures,” according to the memo.
The memo also claims that Robert Kadlec, who served as assistant secretary for preparedness and response under President Trump, previously worked as a consulting for Emergent and “appears have pushed for this [contract] award despite indications that Emergent did not have the ability to reliably fulfill the contract.”
House hearing on Emergent


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