2021 LS&HC Horizons - Flipbook - Page 67
Life Sciences and Health Care Horizons 2021
67
“Buy American” response to the pandemic
As the COVID-19 pandemic has progressed,
legitimate concerns have been raised about U.S.
dependency on drugs, devices, raw materials,
and supplies manufactured abroad. While
the need for vaccines, treatments, tests, and
PPE has come into sharp focus, and has been
addressed in the short term through Operation
Warp Speed contracting and emergency
procurement under the DPA, the broader
need to enhance U.S. manufacturing
infrastructure to support domestic availability
of all critical medicines and inputs has become
increasingly clear.
In 2020, the Trump Administration took
steps toward “onshoring” U.S. manufacturing
of drugs and medical devices with a focus on
strengthening preferences for U.S. products
in government procurements. Trump issued a
much-anticipated “Buy American” Executive
Order in August 2020, intended to increase
and support domestic manufacture and
federal government procurement of “essential
medicines,” “medical countermeasures,” and
“critical inputs” (including API, raw materials,
and medical device components), and decrease
dependency on non-domestic sources.
Legislation has also been introduced to enable
the government to take stock of existing supply
chains for essential medicines and enhance
domestic production.
For its part, just days after the January 2021
inauguration, the Biden Administration
directed contracting agencies to focus on
strengthening preferences for U.S. products
in government procurement, and to consider
products to be identified as domestic based
on value-add manufacture and job creation
in the United States. President Biden is also
expected to issue an executive order calling
for a review of critical supply chains to reduce
U.S. dependence on imports of materials
and equipment.
We expect key government initiatives this
year to include continued orders under the
DPA, amendment of existing procurement
regulations (and possibly statutory changes)
to extend stronger domestic preferences in
federal procurements, and federal funding
and financing initiatives to support domestic
manufacturing and capacity development. We
can expect the Departments of Health and
Human Services (HHS) and Defense (DoD) as
well as the White House COVID-19 Response
Team to be actively involved in these efforts.
In sum, 2021 will likely bring a steady flow of
contracting, rulemaking, and legislative activity
aimed at supporting and expanding domestic
manufacture of pharmaceuticals and devices.
Joy Sturm
Partner, Washington, D.C.
joy.sturm@hoganlovells.com
Allison Pugsley
Partner, Washington, D.C.
allison.pugsley@hoganlovells.com
