House Democrats launch investigation into J&J contractor Emergent

House Democrats have launched an investigation into Emergent BioSolutions, the embattled contract manufacturer of Johnson & Johnson’s coronavirus vaccines, to find out if the company used its relationship with a key Trump administration official to secure federal contracts.

In a letter sent to the company’s CEO and its executive chairman, Democrats on the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis said they were concerned Emergent won contracts “despite a track record of increasing prices without justification and failing to meet contract requirements.”

The Democrats, led by Oversight Committee Chairwoman Carolyn Maloney (D-N.Y.) and coronavirus subcommittee chairman James Clybrun (D-S.C.). demanded a host of documents by May 3. 

Among the requests, the Democrats asked for all federal contracts with the Department of Health and Human Services (HHS) from 2015 to the present, all documents and communications related to the suspected contamination of coronavirus vaccines, and all documents and communications with former Trump administration official Robert Kadlec between November 2016 and January 2021.

Clyburn also requested that the company’s CEO, Robert Kramer, and Executive Chairman, Fuad El-Hibri, testify before the Select Subcommittee on May 19. 

Kadlec worked as a consultant for Emergent until 2015, and was confirmed to lead HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) under President Trump in 2017. 

The Washington Post reported last year that Emergent lobbied the Trump administration to transfer control of the Strategic National Stockpile to Kadlec and his agency, and subsequently received millions of dollars in federal contracts from ASPR, including contracts for the national stockpile that were awarded without competitive bidding.

The Maryland-based company initially received a $163 million contract in 2012 to retrofit and expand its Baltimore manufacturing plant, and prove it could produce 50 million doses of a pandemic influenza vaccine within four months. Emergent ultimately failed to meet a June 2020 deadline to gain approval for the vaccine from the Food and Drug Administration.

But despite subsequent warnings from top federal officials, Emergent received $628 million in June 2020 to establish the primary U.S. facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca.

The FDA continues to investigate Emergent’s manufacturing problems.

On Monday, the company revealed the FDA had ordered the plant to stop producing new Johnson & Johnson vaccine material, and quarantine its existing vaccine stock until agency staff complete an inspection of the facility.

An ingredient mix-up last month ruined 15 million doses of the J&J vaccine, after they were contaminated by ingredients from AstraZeneca’s vaccine.

While the contamination did not impact the safety of any vaccines available to Americans, the lawmakers said they “remain concerned about the circumstances that led to the award of this contract under the prior Administration and whether Emergent’s manufacturing errors could hinder vaccination efforts that are critical to saving lives and ending the coronavirus crisis.”

In a statement, Emergent said it had received the letters.

“We welcome the opportunity to answer the Committees’ questions and to discuss our important work supporting the nation’s public health preparedness and response,” a spokesperson said.

Updated at 5:50 p.m.