Jennifer L. Henn  |  October 16, 2020

Category: Covid-19

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A blue-gloved hand holds a syringe and a vaccine bottle with a label that reads "Covid-19 Vaccine?" - coronavirus vaccine

Public Citizen, a nonprofit consumer advocacy group, has been trying to get information from the federal government about its multibillion-dollar coronavirus vaccine contracts with some of the nation’s top pharmaceutical companies, but the feds have refused.

Now the organization is taking the bureaucracy to court.

Public Citizen filed a federal lawsuit against the Trump administration’s Department of Health and Human Services, or HHS, and the National Institutes of Health (NIH), a department agency, in U.S. District Court for the District of Columbia on Thursday. The group is seeking the court’s intervention in forcing the release of information about the vaccine contracts awarded as part of President Donald Trump’s Operation Warp Speed.

“Operation Warp Speed, which is co-led by HHS, has given more than $10 billion to pharmaceutical corporations. The terms of these contracts remain secret,” Public Citizen says. The information the group is asking for — contracts and records of discussions between the health department and the pharmaceutical companies about manufacturing capacity, pricing and award determinations, among other things — would help to answer some of the public’s questions about the deals.

In April, about a month into the coronavirus pandemic in the U.S., the NIH announced the creation of Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, a joint effort by the public and private sectors to develop therapeutic treatments for COVID-19.

Freedom of Information Act paperwork with a pen and glasses - coronavirus vaccine

Trump announced the creation of Operation Warp Speed in May. That public-private partnership was meant to funnel resources to drug makers to help them develop and distribute an effective and safe coronavirus vaccine as quickly as possible.

In July, federal officials announced they had struck a $2.1 billion deal with Sanofi and GlaxoSmithKline to develop a coronavirus vaccine and deliver 100 million doses, according to The Washington Post.

In August, Trump revealed his administration had awarded a $1.5 billion contract to Moderna for 100 million doses of its expected vaccine after having paid the company $955 million to develop it, CNBC reported.

Among the questions Public Citizen says it is trying to get answers to:

  • “Will pharmaceutical corporations be required to set a reasonable price for their products, or will they be free to profiteer despite the public’s massive investment?
  • “Will taxpayer-funded technology be held as corporate secrets, or can the U.S. government share technology with the World Health Organization to advance scientific research, accelerate manufacturing and more quickly end the global pandemic?
  • “What rights does the U.S. government maintain in the factories it is helping build?”

In pursuit of that information, Public Citizen filed two requests for information and documents related to the coronavirus vaccine contracts under the Freedom of Information Act in May, the lawsuit says.

The first dealt with the Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership. Specifically, the advocacy group asked the NIH for any and all records that deal with whether or how the pharmaceutical “partners” will “share infrastructure, subject matter expertise, funding, data, compounds or intellectual property,” the lawsuit says.

About a month later, NIH officials refused to provide the requested documents, prompting Public Citizen to appeal in July. By law, the government is required to respond to a Freedom of Information Act request within 20 working days.

The NIH has yet to respond, the lawsuit claims.

The second request Public Citizen says it made was to HHS later in May for information about the contracts under the Operation Warp Speed initiative.

In July, HHS responded by asking the advocacy group to be more specific about what it wanted. Public Citizen says it responded later that month with a request for contracts and records of discussions between HHS and AstraZeneca, Emergent Biosolutions, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, Regeneron and any other companies in talks with the federal government about producing a coronavirus vaccine or therapeutic treatments for COVID-19.

So far, Public Citizen says, it had not gotten a response from HHS.

Have you ever requested public documents and been refused? Tell us about it in the comment section below.

Public Citizen is represented by Adina H. Rosenbaum and Oluwadamilola Edirin Obaro of Public Citizen Litigation Group.

The Coronavirus Vaccine Lawsuit is Public Citizen v. National Institutes of Health, et al., Case No. 1:20-cv-02949, in the U.S. District Court for the District of Columbia.

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