WaPo’s 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.
New: Trump administration awarded Emergent BioSolutions up to $120.5m for drug injectors to protect U.S. diplomats from nerve agent attacks. Emergent has quietly recalled tens of thousands of injectors from other buyers & removed them from its product line https://t.co/LI53b7dJdu
— Jon Swaine (@jonswaine) August 18, 2020
Breathtaking disregard shown by MED and others in the USG with respect to the quality and provenance of critical supplies procured for saving the lives of Diplomats facing chemical attacks.
Equally sickening are companies consciously exploiting State.https://t.co/A7rmAXzKn9
— diplomattitude (@diplomattitude) August 18, 2020
Extracted data below from SAM.gov, the new fedbiz, with links to the contracts. Are there more that we’ve missed?
- Unique Entity ID (DUNS)220984617
- CAGE CodeU1C03
- AddressBUILDING 3, LONDON, W4 5YA
- Expiration Date Jun 23, 2021
- Purpose of Registration All Awards
- Debt Subject to Offset No