Letter to Vice President Mike Pence, Mark Esper, Secretary of Defense, and Alex Azar Secretary of Health and Human Services - Warren, Schakowsky Call on Trump Administration to Ramp Up Efforts Publicly Manufacture COVID-19 Medical Products

Letter

Dear Vice President Pence, Secretary Azar, and Secretary Esper:

We write to you today to request information on the federal government's capacity to develop
and manufacture therapeutics and vaccines to combat the coronavirus disease 2019 (COVID-19)
pandemic.

Starting in 2012, the Department of Health and Human Services (HHS) "established three new
centers to develop and manufacture medical countermeasures, such as vaccines and medicines"
in the event of infectious disease outbreaks or bioterrorist attacks.
1 The Centers for Innovation in
Advanced Development and Manufacturing (CIADM) were intended to provide the United
States with an infrastructure of "flexible, nimble, and modern vaccine manufacturing"
capabilities--"the first major domestic infrastructure" of its kind. These centers operated in a
public-private partnership model, "bringing together the innovative ideas of small biotech firms,
the training expertise of academic institutions, and the development and manufacturing
experience of large pharmaceutical companies."

To date, HHS and the Department of Defense have invested nearly $670 million in four CIADM
facilities, and have utilized these facilities in the nation's Ebola and Zika outbreaks response.

This public manufacturing capacity could be critical in combatting COVID-19. However,
according to reporting from The Washington Post, "none of the sites -- in Florida, Maryland,
North Carolina and Texas -- have developed or are close to delivering medicines to counter the
[COVID-19] outbreak." Two of these 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-19.6 Instead, without federal government manufacturing support, HHS's
solicitation proposals for the development of COVID-19 medical products have emphasized that
the agency is "particularly interested" in products and technologies that already "have
established domestic large-scale commercial…manufacturing capability."

Reportedly, in 2018, HHS Assistant Secretary for Preparedness and Response Robert Kadlec
instructed a team of HHS and Pentagon officials to conduct a review of the CIADM sites.
According to the review, "operational capability has not been adequately developed" and would
need to be improved in order "to meet biodefense MCM [medical countermeasures] mission
requirements."8 Assistant Secretary Kadlec initiated another review by nonprofit Mitre
Corporation, which reportedly found "similar deficiencies."

These reports, if true, represent the short sightedness and unwillingness to invest in the public
alongside the private sector that has hamstrung the federal government's public response to the
COVID-19 pandemic. Now, the Administration is reportedly in the process of organizing a
public-private partnership between pharmaceutical companies, executive agencies and the
military called "Operation Warp Speed." The project intends to speed the nation's development
of a COVID-19 vaccine with the goal of producing 300 million doses by next January 2021.
The Administration appears to be relying on private sector actors to deliver on this promise.

We have proposed legislation, the COVID--19 Emergency Manufacturing Act of 2020, which
would give the federal government authority to immediately manufacture and enter into contracts
to manufacture various pharmaceutical drugs, medical devices, and other COVID-19 products to
ensure that we can adequately meet the demands of the moment.

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. In order to better understand the status of CIADM facilities and
other federal government manufacturing efforts, we request answers to the following questions
by no later than May 20, 2020:
1. According to HHS's National Health Security Strategy 2019-2022, the United States
increased "pre-pandemic vaccine antigen manufacturing capacity from 60 million doses
to 600 million doses" after the 2009 H1N1 pandemic.13 Please provide a list of federal
government facilities currently manufacturing products for COVID-19. What is the
current output and maximum capacity of each of these facilities to manufacture medical
countermeasure products, including each of the following:
a. Vaccines, including RNA vaccines, DNA vaccines, recombinant protein vaccines,
viral vector-based vaccines, live attenuated vaccines, and inactivated vaccines;
b. Personal protective equipment, including surgical masks, surgical gowns, face
shields, and N95 masks;
c. Testing materials, including chemical reagents, test swabs, and materials
necessary to develop serological COVID-19 tests; and
d. Drugs and biological products that the Food and Drug Administration have
reported to be in shortage.
2. Please provide a list of federal government facilities that could be rapidly re-tooled to
manufacture the products listed above. What is the added capacity of each of these
facilities for each of the subcategories listed above?
3. Please provide copies of reviews of CIADM conducted at the instruction of HHS in the
past five years.
4. Please provide copies of contracts issued by the Biomedical Advanced Research and
Development Authority (BARDA) and through "Operation Warp Speed" to private sector
actors for the purposes of large-scale manufacturing.
5. Please describe the role of the newly formed National Biopharmaceutical Manufacturing
Partnership between HHS and the Department of Defense to manage these centers.

Thank you for your attention to this matter.

Sincerely,

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