LSHC Horizons Brochure 2024 - Flipbook - Page 13
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | ESG and Supply Chain
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Tapping into the Defense Production Act to strengthen
the pharmaceutical supply chain
In response to the supply chain challenges that
arose during the COVID-19 pandemic, in the
past several years the Biden Administration
has taken steps aimed at strengthening
the U.S. industrial base. A key focus has
been shoring up domestic manufacturing
capabilities to help ensure a sufficient supply
of drugs, countermeasures, and other critical
items to support public health. Following on
the significant activity in 2023, we expect
additional focus in this area in the coming year.
In November 2023, the Biden Administration
convened the first meeting of the White
House Council on Supply Chain Resilience.
Subsequently, in late December 2023,
President Biden published a Memorandum for
the Secretary of Health and Human Services
that included a Presidential determination
stating that essential medicines, medical
countermeasures, and critical inputs are vital to
the national defense and also included a waiver
that in effect, expands the Department of
Health and Human Services’ (HHS) authority
under Title III of the Defense Production Act
(DPA) to further the goal of bolstering domestic
production capabilities for these products.
The DPA provides agencies with extraordinary
contracting authority and the ability, through
“rated orders”, to prioritize supply to the
government. President Biden’s actions followed
up on prior executive orders that were focused
on building up long-term supply of essential
medicines, in light of the vulnerability that was
exposed during the pandemic.
Joy E. Sturm
Partner
Washington, D.C.
HHS will start by investing $35 million in
domestic production of key starting materials
for sterile injectable medicines. To facilitate
its work, HHS Biomedical Advanced Research
and Development Authority (BARDA)
created a consortium, the Biopharmaceutical
Manufacturing Preparedness Consortium
(BioMaP-Consortium), which boasts members
from various segments of the drug and vaccine
manufacturing supply chain. The Consortium
recently issued its first Request for Project
Proposals. The formation of the Consortium
signals that there will be more activity,
and likely more investment, as it is widely
recognized that $35 million is just an initial
investment. To make an impact much more
significant, injection of additional funding will
be needed.
Allison D. Pugsley
Partner
Washington, D.C.
Lauren Colantonio
Associate
Washington, D.C.
