May 07, 2020

Warren, Schakowsky Call on Trump Administration to Ramp Up Efforts Publicly Manufacture COVID-19 Medical Products

Requests Information on Status of Federal Government Manufacturing Sites and Efforts

Text of Letter (PDF)

Washington, DC - Today, United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Committee on Health, Education, Labor, and Pensions, and Representative Jan Schakowsky (D-Ill.), Chair of the Energy and Commerce Consumer Protection and Commerce Subcommittee, called on the Trump Administration to coordinate its domestic manufacturing efforts to produce COVID-19 medical products and requested information on the federal government's capacity to develop and manufacture therapeutics and vaccines. Last week, Senator Warren and Representative Schakowsky introduced the COVID-19 Emergency Manufacturing Act to publicly manufacture personal protective equipment, prescription drugs, and other medical supplies necessary to combat the COVID-19 pandemic. 

Reports indicate that none of the sites previously established to enable the federal government to manufacture medical countermeasures such as vaccines and medicines "have developed or are close to delivering medicines to counter the [COVID-19] outbreak." Starting in 2012, the Department of Health and Human Services (HHS) established The Centers for Innovation in Advanced Development and Manufacturing (CIADM). In the event of infectious disease outbreaks or bioterrorist attacks, the CIADM sites were created "to develop and manufacture medical countermeasures" and were intended to be the "the first major U.S. domestic infrastructure" of its kind. HHS and the Department of Defense have invested nearly $670 million in four CIADM facilities to date and have utilized these facilities in the nation's Ebola and Zika outbreaks. 

However, reporting from the Washington Post found that two of the sites are expected "to conduct small-scale testing of potential coronavirus vaccines," while the other two sites are not expected to take a role at all in fighting COVID-19. The reporting also indicated that a HHS-sanctioned review of the CIADM sites found that "operational capability has not been adequately developed" and would need to be improved in order "to meet biodefense MCM [medical countermeasures] mission requirements." 

The Members noted that the Trump Administration is reportedly in the process of organizing a public-private partnership between pharmaceutical companies, executive agencies and the military called "Operation Warp Speed" to speed the nation's development of a COVID-19 vaccine but seems to only be relying on private sector actors to deliver on this promise. 

The Members wrote: "We have proposed legislation, the COVID-19 Emergency Manufacturing Act of 2020 ...We intend to keep working to make that plan law. In the interim, however, the federal government should work expeditiously to coordinate its domestic manufacturing efforts for COVID-19 medical products." 

The Members also requested answers to their questions to better understand the status of CIADM facilities and other federal government manufacturing efforts by no later than May 20, 2020.