2021 LS&HC Horizons - Flipbook - Page 7
Life Sciences and Health Care Horizons 2021
7
COVID-19
Emergency use authorizations
At the beginning of 2020, no one would have
predicted the COVID-19 pandemic and the global
health crisis it would create. Nor would they have
predicted the way industry stepped up to confront
the pandemic head-on through development and
innovation, or how regulators would find creative
ways to speed products to market while balancing
the risks and benefits to public health.
In the U.S., the Food and Drug Administration
(FDA) quickly started issuing emergency use
authorizations (EUA) for ventilators, COVID-19
tests, and personal protective equipment (PPE)
and issued the EUAs for the vaccines faster
than has ever been seen before. We believe that
FDA will continue to issue EUAs well into 2021,
but these new products will need to address
FDA’s evolving understanding of what product
characteristics should be prioritized during the
public health crisis. Clearly FDA will continue
to authorize vaccines and diagnostic/screening
tests, but as FDA has limited resources and must
prioritize its EUA review based on the agency’s
perception of need, this will mean that many EUA
applications will not be accepted by FDA, and
some will never even be reviewed.
In addition, as the COVID-19 response initiatives
bring the pandemic under control, companies
will need to plan for the end of the public
health emergency and the lapsing of their
EUAs –in terms of capital equipment that has
been distributed (e.g., ventilators, temperature
sensors, remote patient monitoring software
and equipment), transitioning to normal
market authorizations (or not), and preparing
for regulatory enforcement for products that
were released without following the appropriate
regulatory channels (e.g., securing the necessary
EUAs or authorizations in the EU).
In the EU and the UK, the pandemic also forced
competent authorities to adapt their regulatory
frameworks governing essential products,
including COVID-19 tests, surgical face masks,
and PPEs. Due to the emergency, some of these
products have been temporarily authorized
while not being CE marked. These special
authorizations are becoming more difficult to
obtain as the epidemic situation normalizes.
Most recently, the competent authorities also
granted marketing authorizations to the first
COVID-19 vaccines with the aim to definitively
putting an end to the pandemic. We have been at
the forefront with our clients as they respond to
the public health need for tests, equipment, PPEs,
and therapeutics, and we will continue to lead
as we offer guidance while we emerge from this
pandemic together.
Jodi Scott
Partner, Denver
jodi.scott@hoganlovells.com
Fabien Roy
Partner, Brussels
fabien.roy@hoganlovells.com
Blake Wilson
Counsel, Philadelphia
blake.wilson@hoganlovells.com
