How Operation Warp Speed’s Big Vaccine Contracts Could Stay Secret

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29 Сен 2020, 23:45

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President Trump announced the creation of Operation Warp Speed in May to fast-track a coronavirus vaccine. He called it «a massive scientific and industrial, logistic endeavor unlike anything our country has seen since the Manhattan Project.»

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Kathryn Ardizzone, a lawyer at Knowledge Ecology International, examined a handful of early Operation Warp Speed research and development contracts obtained through public records requests to HHS that didn’t go through an intermediary. KEI is a nonprofit group that focuses on intellectual property policy.

Many were OTAs that weakened or excluded Bayh-Dole clauses, which, among other things, allow the government to «march in» and take control of a drug or vaccine if a manufacturer that received federal funding engages in price gouging, for example.

Ardizzone and NPR have both, separately, tried to get copies of the later (and larger) procurement contracts through public records requests and so far have been unsuccessful. We requested contracts between the federal government and the pharmaceutical companies — not the intermediary, Advanced Technology International.

In response to NPR’s request, HHS said it had «no records» for the $1.6 billion contract with Novavax, indicating that the department leading the way on Operation Warp Speed doesn’t have a copy of the contract. NPR has since made the same request of the Department of Defense and is awaiting the response.

«It’s not clear that using the Freedom of Information Act, we can access agreements that are maintained by a private entity,» Ardizzone says. In that case, we don’t know what taxpayer protections the contracts may have left out.

«The stakes are as high as you could ever imagine,» Ardizzone says. If the government doesn’t have a copy of these records, something she called «shocking but not impossible,» it would «add a layer of complexity» to whether the contracts can be disclosed under a public records request.

Repurposing a Defense Department consortium

Advance Technology International manages contracts and facilitates dealings with the government for several consortia of academics, companies and more, using OTAs.

In March and early April, the Department of Defense talked with ATI about a consortium of academics and companies that it manages called the Medical CBRN Defense Consortium, which is tasked with developing medical countermeasures to threats against the military. The Department of Defense, a partner in Operation Warp Speed, already had an overarching OTA with ATI concerning this group. To expand it for the COVID-19 response was a matter of adding more money and issuing a request for proposals concerning coronavirus vaccines and other COVID-19 items.

«The federal government came to me and said, you know, you already have all the members … all the industrial organizations that we would want to complete this work with,» ATI former Chief Operating Officer Robert Tuohy tells NPR. He stayed on as a consultant since stepping down as COO in 2019. (The Medical CBRN Defense Consortium added Pfizer and Novavax to its membership, according to an August notice in the Federal Register.)

In a bureaucratic twist, ATI was never explicitly told it was helping with Operation Warp Speed, Tuohy says, calling that fact «invisible» to the nonprofit.

«So the government then asks us to actually run a competition very similar to what the government would run within the membership of the consortia,» he says, adding that it saves the government time and resources. ATI’s job is to put out a request for proposals, collect the essential information (which is typically less than what’s required in FAR-based contracts), make sure they’re all in the same format and send them to the federal government for evaluation. Once the federal government makes its decision, ATI issues its own OTAs to the chosen members.

«Then they hand us the money and ask us to award essentially a sub-OTA to the team that they have selected within the membership of the consortium,» says Tuohy.

The Medical CBRN Defense Consortium was set up about four years ago to do contract work concerning chemical, biological, radiological and nuclear defense «as related to enhancing the mission effectiveness of military personnel.» As a result, Ardizzone wonders if it’s operating too far outside its original scope. This, she says, could be a sign the intermediary arrangement is «to just avoid the procedures and regulations that protect the American public in the government contracting process.»

Tuohy says the consortium was established with a flexible mission, adding that OTAs often get a bad rap, but they don’t deserve it. Even if the contracts don’t include things like the Bayh-Dole protections, he says they often have similar replacement language. When asked about whether these contracts could be disclosed to the public under public records requests, he said it was up to the government. ATI couldn’t point to an example of one of its contracts to consortium members being disclosed this way, but this may have happened without it being made aware.

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Reporters asked Operation Warp Speed officials about when the contracts would be released to the public during a press briefing on Sept. 16.

«With respect to the contracts, the contracts are between ourselves, the United States government and private entities, and they are releasable to an extent. Obviously everything cannot be released, but they are releasable to an extent and they will be made available at some point in time,» said Lt. Gen. Paul Ostrowski, who directs Operation Warp Speed’s efforts on supply, production and distribution. «And I will tell you that they entail information that allows us to all know that we paid a fair and reasonable price for each one of these vaccines as we went forward.»

Feldman, of UC Hastings, says the administration’s comparison of Operation Warp Speed to the Manhattan Project is troubling.

«I think that’s completely the wrong image,» she says. «The right analogy, I think, for Operation Warp Speed is the penicillin effort in World War II. So there, the nation mobilized to create the entire penicillin industry. It changed how we treat disease. It ushered in the era of mass-produced pharmaceuticals. That’s what I think as the best you could do here. But it’s a completely different image than Manhattan Project.»

She says the penicillin effort is proof that public-private partnerships can produce great work.

«We can do a lot of good together, but we have to make sure pharma companies aren’t taking advantage of the crisis,» she says. «And we know from history that some will try. We know from history — current and past — that some will try.»