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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.
A Post examination found that after a number of production problems, Emergent last year quietly began to recall tens of thousands of Trobigard units from foreign buyers and removed Trobigard from the official product line on its website and in its securities filings. The examination shows that Emergent secured contracts to supply an unproven medical treatment at a time when the mission of protecting U.S. diplomats against chemical attacks had taken on fresh urgency, in an effort the government code-named Project Mandrake.
The Post 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.
Separate from its work for the State Department, Emergent is among the largest suppliers of vaccines to the Strategic National Stockpile. The company built its market position by acquiring biodefense competitors and the rights to various treatments, as it did in the case of Trobigard.
Nina DeLorenzo, an Emergent spokeswoman, said in a statement that Wolling's views were "taken seriously" but "do not and did not necessarily represent the company's position."
DeLorenzo said the brochure on which Wolling commented "is old and has been superseded." Asked whether it had been shown to State Department officials, she said: "We are contractually restricted from discussing this."
DeLorenzo attributed the recalls of Trobigard from the militaries of the United Arab Emirates and Italy to a flaw detected by Emergent's "rigorous quality processes" in a small minority of injector devices She said no injectors sold to the State Department were affected.
DeLorenzo said the subsequent decision to move Trobigard from the "products" section of Emergent's website and securities filings to a "pipeline" of products in development was part of a "wide-ranging internal review" and was not due to any "specific concerns about the product."
Asked directly whether Trobigard works, DeLorenzo said, "While we are restricted in what claims we can make about Trobigard under applicable law, it is considered by government customers to be an essential defense against a chemical weapons attack and we stand by it." She added, "We have conducted studies to assure ourselves and our customers that the auto-injector device will perform as our government customers expect."
Although Emergent is seeking approval for Trobigard from health authorities in Belgium, it has not sought approval from the U.S. Food and Drug Administration - a circumstance that bars the product's sale in the United States. 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, according to a company record.
A State Department spokesman, Ruben Harutunian, declined to comment on The Post's findings.
In addition to the State Department deals, Emergent has been awarded contracts worth up to $75 million by the Defense Department to develop other injectors for potential use by troops to counter certain kinds of chemical attacks.
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Government officials, including at the State Department and the national stockpile, had previously bought FDA-approved auto-injectors of nerve agent antidotes from Meridian Medical Technologies, a division of Pfizer. But in 2013, Meridian halted manufacture of its injectors after some were found to be faulty. This set off shortages across the government as the devices expired and could not be restocked.
In August 2015, Emergent, primarily a vaccine maker at the time, entered the drug-injector market. The company bought the rights to an injector from an Austrian firm in a licensing deal and rebranded it as Trobigard. Emergent said the Austrian firm previously sold the injector with the same drug combination to military buyers.
Over the following year, Emergent secured contracts with governments such as the UAE and Kuwait for tens of thousands of Trobigard devices, which are spring-loaded "auto-injectors" that allow individuals to administer the antidote to themselves merely by pressing the injector firmly against a thigh.
But little testing was performed to check that the drug combination worked, The Post found. Wolling, the regulatory director, warned colleagues in a June 2016 email to "exclude efficacy claims" about Trobigard from pitches to potential buyers.
"We have not substantiated that this co-formulated product is efficacious or safe, and have never tested against nerve agents as an antidote," Wolling wrote.
Referring to the two drugs in Trobigard, DeLorenzo acknowledged that "Emergent has not tested the safety or efficacy of atropine and obidoxime co-formulated."
"Emergent made clear to government agencies interested in procuring Trobigard that they were doing so based on their own determination of need, without this type of safety or efficacy data from Emergent," DeLorenzo told The Post.
But she noted that the combination was consistent with a recommendation by the Organization for the Prohibition of Chemical Weapons that nerve agent attacks be countered by administering atropine and an oxime, a class of drugs that includes obidoxime. The drugs in Trobigard also are listed as treatments for nerve agent poisoning in a federal government emergency health database, and they previously have been combined in injectors sold by smaller companies overseas.
Wolling, who has since left Emergent, declined to comment.
In October 2016, Dan Mallon, then an Emergent executive on the Trobigard program, acknowledged to colleagues that Emergent sales representatives had made unsupported claims about Trobigard to clients and said the practice would end, according to two former company employees familiar with his remarks. The former employees, like several others interviewed for this story, spoke on the condition of anonymity because they were not authorized to discuss the matters publicly.
Mallon, who also has left Emergent, did not respond to messages seeking comment.
DeLorenzo said Emergent initially used sales materials produced by Trobigard's prior owner but later "upgraded" them. Asked whether unsupported claims were made to the State Department, DeLorenzo said Emergent "responded truthfully and accurately" to a solicitation.
By 2017, production problems had begun to arise. A discoloration was found on some Trobigard injector units after sterilization. The "red spots" issue, as it was known internally, led to a company review, Emergent documents show.
DeLorenzo said the cause was a chemical used inside the injectors, which was occasionally found deposited on the outside of devices. She said that the discoloration had "no adverse impact to product quality beyond visual appearance" but that discolored units were discarded.
"We have made improvements to reduce the number of times a situation like this can occur," she said.
More concerning was that Emergent scientists also discovered that greater physical force was needed to activate some injectors than was expected, according to company records and interviews. Former Emergent employees said the problem was so persistent that some in the Trobigard team had T-shirts made with the slogan: "May the activation force be with you."
Sales were disrupted. In January 2017, a senior Emergent executive wrote to the UAE acknowledging "production challenges." Emergent sent the UAE 20,000 injectors needing extra activation force on the condition that they be labeled "emergency use only."
In an email to colleagues in March 2017, Mallon said that the source of the problem had not been identified and that "the root cause may be multi-variate."
DeLorenzo said Emergent "encountered some issues with activation force that have since been addressed." She said a company study found "men and women with varying hand and arm strength" were able to use the devices. "All pharmaceutical products and drug-device combinations encounter hurdles in development," she said.
In June of 2017, Wolling raised the flags about the assertions in the Trobigard product brochure. She posted 17 comments on a PDF version of the document that was circulated to colleagues. Also among them was an objection to a claim that the injector devices had been "designed to meet military requirements."
Around this time, the Centers for Disease Control and Prevention needed to replenish stocks of injectors in the national stockpile. After conducting market research, it opted for a rival product from a firm in Israel. The Israeli firm, Rafa Laboratories, received an emergency FDA approval for its product in April 2017.
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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.
"It is vital to rapidly establish new sources of autoinjector countermeasures to maintain the safety of deployed Department employees," the documents said.
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 Emergent deal called for replacing the State Department's entire stock of Meridian injectors with Trobigard, a department spokesperson said.
The lack of FDA approval for Trobigard led both sides of the deal to take unusual steps, according to former company employees with knowledge of the arrangement.
Rather than selling Trobigard through its company structure in the United States, company documents show, Emergent used a small subsidiary in Britain. Injectors were assembled in Germany and Switzerland and transported to U.S. embassies directly from Europe.
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."
Securing further orders from the State Department was an explicit part of Emergent's company strategy. A corporate strategy document for 2018 said the company aimed to "secure State as anchor tenant for Trobigard product" and "maximize funding for State" to buy more products. Such funding depends on appropriations by Congress.
In November 2017, Emergent hosted senior State Department officials at a facility in southern Germany where Trobigard is manufactured. The trip left a good impression on William Walters, who is a physician and was the senior department official overseeing the contracts, according to another official.
"Dr. Walters and team enjoyed the visit and facility walk more than I thought possible," the U.S. official, Klemens Schmidt, told Emergent executives in an email the following Monday. "You hit a home run with the entire event."
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In August 2018, regular testing by Emergent revealed that some sample devices retained from batches sold to the UAE failed to deliver a full dose. "Plunger did not fully expel the drug contained in the cartridge," said part of the text on a slide included in an internal presentation to executives.
An internal inquiry blamed an "inadequate silicone layer in the barrel of the cartridges," records show. Emergent formally recalled eight batches of the auto-injectors from the UAE, beginning with 61,000 units in January 2019.
Emergent's contract with the State Department said it must report "any issues with the safety and efficacy of delivered or ordered products and/or manufacturing or quality of the production lines" within two business days.
Company leaders concluded that the UAE recall did not trigger this obligation because batches used for the State Department's orders were not affected, current and former company officials said.
DeLorenzo declined to comment on that decision. "We are contractually restricted from commenting on our interactions with the State Department," she said.
Emergent's management team was told of the recall in a Jan. 24, 2019, email from two senior executives. The email was labeled "for internal use only" and noted that the company would not be making a public statement.
Emergent was then on the verge of securing another deal with the State Department. Late the following month, the company announced a new contract, for up to $100 million, to supply the department with more Trobigard, lotion for treating chemical burns and other treatments. Emergent was the sole bidder.
Around that time, two senior U.S. officials assisted Emergent as it sought to sell Trobigard to foreign governments, The Post found.
In March 2019, Walters told an executive at Emergent that his counterparts in Japan wanted to buy auto-injectors and offered to broker an introduction, according to a State Department official. Walters declined to comment.
After a visit to Japan, President Donald Trump's health preparedness chief, Robert Kadlec, an assistant secretary of the Department of Health and Human Services, also advised Emergent's top in-house lobbyist, Christopher Frech, about the potential opportunity in Japan, according to two people familiar with the matter.
A spokeswoman for Kadlec, Carol Danko, said, "Dr. Kadlec was contacted by Japanese senior government officials asking for American suppliers of medical countermeasures in preparation for the Olympic Games, and Kadlec provided them contacts with multiple suppliers."
Records show that Emergent is the largest contractor to Kadlec's office at HHS, which now controls the national stockpile. In the years before he joined the administration, Kadlec was a paid consultant to Emergent and formed a start-up firm with Emergent's chairman. Kadlec and Emergent previously told The Post that their past work together has no impact on Kadlec's work at HHS.
DeLorenzo declined to say whether Japan ultimately bought Trobigard.
Further testing in May 2019 found that samples drawn from Trobigard injectors sold to Italy showed problems similar to those that led to the UAE recall. Six batches of the injectors provided to Italy were recalled. In this case, the company alerted the State Department and other customers.
DeLorenzo said the company concluded that the silicone problem was "strictly limited" to the batches that were recalled. "Emergent continues to monitor Trobigard batches for conformance to the product specifications throughout the product's shelf life," she said.
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.