Emergent Reveals Document Requests From Federal and State Law Enforcement, Regulatory Agencies

Emergent BioSolutions, which botched 75 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine, has said publicly for the first time that it has gotten records requests from a slew of federal investigators related to its COVID-19 contracts.

In its quarterly earnings report published Friday, the company said it had “received preliminary inquiries and subpoenas to produce documents” from Reps. Carolyn Maloney (D-N.Y.) and Jim Clyburn (D-S.C.), members of the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis, Sen. Patty Murray (D-Wash.) of the Committee on Health, Education, Labor and Pensions, the Financial Industry Regulatory Authority, the Department of Justice, the Securities and Exchange Commission (SEC), the Maryland Attorney General’s Office and the New York Attorney General’s Office.

Emergent didn’t detail the type of documents requested, but listed the revelation under the “Securities Litigation” section of the company’s Form 10-Q.

Emergent said that it is “producing and has produced documents as required in response and will continue to cooperate with these government inquiries.”

Rockville, Md.-based Emergent — a go-to company for the U.S. government on many biodefense contracts, including an anthrax vaccine — had received $628 million from a federal contract to be the primary U.S. manufacturer of the J&J and AstraZeneca vaccines. But FDA inspections soon found that Emergent repeatedly violated current good manufacturing (GMP) practices, including those that allowed cross-contamination with AstraZeneca’s adenovirus-vectored COVID-19 vaccine. As a result, 75 million doses of J&J’s vaccine had to be dumped, and production was put on hold for three months.

According to a June memorandum from Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, Emergent repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination (DID, July 6).

In a conference call last week, Emergent leaders said the company had experienced a $41.5 million loss from having to throw away J&J doses labeled unusable and that it spent $12.4 million to clear up GMP issues at the Bayview location.

In early July, Emergent was hit with a potential class-action lawsuit alleging the company made false and misleading statements regarding its manufacturing capabilities and quality control processes. The complaint seeking class-action status was filed by a shareholder in the U.S. District Court for the Southern District of Maryland.

The company also faces a House Committee investigation and many shareholder lawsuits.

Last week, the FDA gave Emergent the go-ahead to restart manufacturing J&J’s COVID-19 vaccine, but the agency stipulated that any vaccine doses produced at the plant still aren’t covered under J&J’s Emergency Use Authorization, thus the agency will need to individually clear any drug batches produced at the plant (DID, July 29).

J&J, which is overseeing the facility, said it will work on securing FDA authorization for drug substances manufactured at the Bayview plant “as quickly as possible.”

Read Emergent’s SEC report here: bit.ly/3loOZtC. — Suz Redfearn