@StateDept Spent Millions on AutoInjectors to Counteract Nerve Agent Exposure, Guess What Happened?

WaPo’s Jon Swaine has an investigative piece on a $120 million State Department contract on a treatment for nerve agent poisoning. According to the report, WaPo has “obtained internal company records, reviewed emails from Emergent staffers and government officials, and interviewed nine people involved in making, selling or buying the Trobigard injectors.”
WARNING! This will get you mad.

“In June 2017, a director of regulatory affairs at the government contractor Emergent BioSolutions told colleagues that she objected to claims the company was making in a brochure for one of its newer products: a drug injector for victims of exposure to nerve agents.

“Functionality testing has not been successful in this device,” Brenda Wolling wrote in comments obtained by The Washington Post. Regarding a claim that the injector was designed to withstand “challenging operational and logistical conditions,” she wrote, “No testing ever conducted.” Even to describe the product as a “treatment of nerve agent poisoning,” Wolling wrote, “implies that we have efficacy data showing it works.”

Three months later, the Trump administration awarded Emergent a $20 million no-bid contract to supply those very injectors to the State Department. The firm later received a second contract, worth up to $100 million, to supply the agency with more of the injectors — sold under the name Trobigard — and related treatments.”

Apparently, the State Department told Emergent that it had obtained a legal opinion from the FDA’s general counsel saying the department could buy Trobigard for use by U.S. diplomats overseas, citing a company record. The report says, the company “has not sought approval from the U.S. Food and Drug Administration — a circumstance that bars the product’s sale in the United States.”

“By September 2017, State Department officials were increasingly alarmed at chemical weapons use by the Syrian regime and the Islamic State and were anxious to boost protections for U.S. diplomats. The agency gave Emergent a one-year contract worth $20.5 million to supply auto-injectors. Under the deal, Emergent delivered 456,845 auto-injectors — enough to provide several for each of 58,000 Foreign Service officers and local employees overseas.

No bid competition was held, on the grounds that there was “unusual and compelling urgency” after Pfizer’s production halt, according to contract records. The injectors were needed to protect officials who “operate in countries with active and/or assumed chemical [redacted] programs,” the records show.
[…]
Emergent’s 2017 deal with the State Department entailed a sharp increase in spending by the department above earlier plans. In August 2015, the department had been preparing to pay Meridian $750,000 per year for five years to replace expiring devices, according to records of an abandoned deal.”

The company-funded study in the Netherlands tested the drugs on guinea pigs exposed to sarin gas. That’s right guinea pigs.

“Six weeks after the State Department signed the deal, Emergent’s first study of Trobigard’s drugs was completed. The company-funded study in the Netherlands tested the drugs on guinea pigs exposed to sarin gas and recorded positive findings. As they published their work in a scientific journal, the study’s authors warned that the results “cannot be directly extrapolated to the human situation.”

Can the embattled OIG still take this on as a special project? Can House Foreign Affairs (HFAC) or House Oversight Committee (HORC) take a look?

“In July, Emergent leaders ordered that Trobigard sales materials be scrapped and that the device be moved to a portion of the company’s website that lists products in development, the company confirmed. They also told staffer to make sure all future sales materials for Trobigard were approved by the company’s medical, legal and regulatory departments.

Emergent put together evidence that all injectors bought by the State Department were safe, former employees said. Government officials ultimately agreed. In September 2019, the State Department authorized the payment of a $10 million contract installment to Emergent.”

You need to read this in full. A State Department “no comment” is not acceptable.

Extracted data below from SAM.gov, the new fedbiz, with links to the contracts. Are there more that we’ve missed?

EMERGENT COUNTERMEASURES INTERNATIONAL LTD

  • Unique Entity ID (DUNS)220984617
  • CAGE CodeU1C03
  • AddressBUILDING 3, LONDON, W4 5YA

Registration

  • Expiration Date Jun 23, 2021
  • Purpose of Registration All Awards
  • Debt Subject to Offset  No

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USEU Gordon Sondland’s Home Renovation in Brussels: Much Higher Than First Reported

 

WaPo and Vanity Fair both reported about the renovation at the Chief of Mission Residence in Brussels, the official residence of the US Ambassador to the European Union Gordon Sondland. Excerpt via Vanity Fair:

A sampling of State Department contracts reveals that since September 2018—just a few months after Sondland’s Senate confirmation—the embassy in Brussels has been awarded $95,109 for a pergola, $13,301 for a pool-Jacuzzi heating system, $33,625 on wooden household furniture, $208,683 on a professional kitchen remodel, and two bathroom renovations, one costing $53,809 and the other $82,354. Additionally, the State Department spent $103,748 on a hotel, to ostensibly serve as an alternate residence to the embassy while the building undergoes renovations for months of September and October of this year. (In a statement, a spokesperson for the State Department confirmed that updates to the residence had been funded in 2019 “as part of its regular 17-year cycle of reviewing and refreshing furnishings and interior décor in representational residences.”)

WaPo’s reporting estimates the renovations at nearly $1 million including a $209,000 professional kitchen, and a $223,000 family kitchen. The actual obligation may  actually be higher than first reported.
A sourced familiar with the matter told us that the Chief of Mission Residence (CMR) was built in 1990 so one’s guesstimate is that the residence is  due for renovation as one of those “representational spaces.” The first contracts were awarded in September 2018, just two months after Sondland got to Brussels. (Sondland was confirmed via voice vote on June 28, 2018). Folks who understand how funding in government works can see that this “wasn’t all his initiative.” But .. because there’s always a but,  we understand from our source that the great bulk of the project items were added “more recently.” The Bureau of Overseas Building Operations  (OBO) reportedly approved all of it and the Office of Acquisition Management (State/AQM) awarded the contracts.
So a fairly modest renovation project was amped up until the contract award to an 8A firm reached $2.5 million?  More? Our source also told us, “Whether that much renovation was needed, or exactly how lavish is too lavish for a representational residence, I can’t say.”
Definitive Contract 19AQMM19C0088 is a Fixed Price Federal Contract Award. It was awarded to Pono Aina Management LLC of Oklahoma on Jun 12, 2019. The definitive contract is funded by the Bureau of Overseas Building Operations (DOS). The potential value of the award is $2,504,000 with potential end date of June 11, 2020. The solicitation procedure is marked “simplified acquisition” and  the set-aside type is marked “8(A) Sole Source.”