Law360 (October 15, 2020, 4:33 PM EDT) -- The Trump administration is stonewalling a consumer advocacy group's request for details about the federal government's billion-dollar contracts with Moderna, Pfizer and other pharmaceutical giants for COVID-19 vaccine development and manufacturing, according to a lawsuit filed Thursday.
Public Citizen's lawsuit, filed in D.C. federal court, stems from a Freedom of Information Act request seeking more information from the U.S. Department of Health and Human Services and the National Institutes of Health about the vaccine campaign Operation Warp Speed, which the government said is on track to deliver over 300 million doses of an effective vaccine by January.
In August, Moderna landed a $1.5 billion supply agreement with the U.S. Department of Defense and HHS to manufacture 100 million doses of its COVID-19 vaccine candidate and nabbed $2.48 billion in government funds to get the potential vaccine off the ground, according to a statement from the company at the time. The government has also made similar deals with Sanofi, GlaxoSmithKline and Johnson & Johnson.
But those deals have been shrouded in secrecy, Public Citizen says in Thursday's lawsuit. In response to the nonprofit's initial request in May, HHS failed to turn over information about how Operation Warp Speed participants will share information about infrastructure, funding and intellectual property and what steps they will take to ensure access to the vaccine, according to the lawsuit.
"There is no legal basis for HHS's failure to produce the responsive records," the nonprofit said.
Even after narrowing down its FOIA request in late July, Public Citizen says, HHS still refused to turn over information about discussions between the agency and the pharmaceutical giants. Among those companies are AstraZeneca, Johnson & Johnson, Moderna, Pfizer and Regeneron, which have received over $10 billion from Operation Warp Speed since May, the nonprofit says.
Obtaining the information is critical to answer questions about whether the companies will be restricted in what they can charge for their products, whether the new technologies are corporate secrets and to what extent the government will have rights over the factories it's funding, Public Citizen says.
"The success, failure and terms of Warp Speed projects may determine when and under what conditions people living in the U.S. receive a safe and effective vaccine," Peter Maybarduk, director of Public Citizen's Access to Medicines program, said in a statement. "Taxpayers deserve to know what they are getting in return for their billions of dollars in investments."
Public Citizen is the latest advocacy group to take the Trump administration to court seeking more details about its vaccine campaign. Knowledge Ecology International, a nonprofit organization that advocates for access to medical technologies, sued the government Oct. 9 seeking information about the NIH's contributions to Gilead Sciences Inc.'s antiviral drug remdesivir and other grants and contracts.
Lawmakers have also been probing Operation Warp Speed for possible conflicts of interest. Democrats on the House Select Subcommittee on the Coronavirus Crisis have maintained that the process for choosing vaccine candidates has not been transparent, and that "the reasons for selecting or rejecting particular candidates" were not made public.
Representatives for the government did not immediately respond to requests for comment.
Public Citizen is represented in-house by Adina H. Rosenbaum and Oluwadamilola E. Obaro of the Public Citizen Litigation Group.
Counsel information for the government was not immediately available.
The case is Public Citizen v. National Institutes of Health et al., case number 1:20-cv-02949, in the U.S. District Court for the District of Columbia.
--Additional reporting by Hailey Konnath, Adam Lidgett and Alyssa Aquino. Editing by Abbie Sarfo.
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