Emergent BioSolutions' influence within the federal government has been placed under a spotlight ever since a manufacturing flub forced the contractor to discard millions of doses of Johnson & Johnson's COVID-19 vaccine. Now, two of the company's top execs are headed to Congress to discuss that work before lawmakers it helped elect.
On Wednesday morning, Emergent founder and executive chairman Fuad El-Hibri and CEO Robert Kramer will testify before the House Select Subcommittee on the Coronavirus to discuss their company's production problems, political connections and the hundreds of millions of dollars it received in federal funding last year to manufacture pandemic vaccines.
At least three members on the panel have benefited directly from Emergent's political spending, The New York Times reports. El-Hibri and his wife since 2018 have pledged at least $150,000 to campaigns and groups affiliated with the panel's top republican, Representative Steve Scalise of Louisiana, according to federal campaign records.
Meanwhile, Representative Jim Jordan (R-Ohio) and Representative Jamie Raskin (D-Maryland)—both involved in the panel conducting Wednesday's hearing—each received contributions of $1,000 from Emergent's Employees PAC during the 2020 election cycle, the NYT wrote.
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Raskin told the NYT he hadn't been aware of the donation until the newspaper reached out to him for comment. He's since returned the money, he said. A spokesperson for Jordan, meanwhile, said the contribution had no bearing on the congressman's legislative work.
Political donations are par for the course in Washington, but the situation becomes harrier when accounting for the fact that the federal government is Emergent's chief client. Aside from questions about Emergent's $628 million pandemic manufacturing contract, the CDMO has taken heat for its upsized role in supplying anthrax vaccines to the U.S. Strategic National Stockpile over the years.
"Emergent has performed many vital missions for the United States Government since its founding in 1998, and especially since the nation focused on the critical importance of biodefense after the September 11th terrorist attack and subsequent anthrax attacks," an Emergent spokesperson told Fierce Pharma.
He pointed out that the company's COVID-19 manufacturing duties are "unlike any we have confronted before." The company is eager to "clarify misconceptions" and address the committee's concerns, he added.
Right now, the company is focusing "on the path forward to release drug substance currently under evaluation, to resume production, and to do our part to help strengthen the global supply chain for Johnson & Johnson’s COVID-19 vaccine," he said.
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The company has spent around $3 million per year on lobbying over the past 10 years—far more than that of similarly sized companies but in line with Big Pharma's AstraZeneca and Bristol Myers Squibb, whose annual revenues are at least 17 times higher, the NYT noted.
The hearing comes after Emergent made major headlines back in late March after an NYT report that it had ruined up to 15 million doses of the J&J shot. Since then, the FDA has investigated the plant and laid out a laundry list of issues for the company to correct. Emergent has not been authorized to resume production after halting manufacturing there in mid April.
Meanwhile, Emergent has privately admitted to serious manufacturing problems in its response to the FDA’s April inspection of its Baltimore plant, the House committee said in a memo released ahead of Wednesday morning’s hearing. Emergent placed the blame on the “sudden scale-up to full-scale manufacturing activities for two different Covid-19 vaccine drug substances,” which fueled “a dramatic increase in storage and staging demands” and strained capacity as its facility “operated at full capacity for the first time.”
Emergent last week unveiled a "comprehensive quality enhancement plan" to right the ship at its Baltimore Bayview plant, which was responsible for the discarded Johnson & Johnson doses. The company has also initiated a manufacturing shakeup and during its first-quarter earnings call, Kramer took "full responsibility" for the error.