LS&HC Horizons 2022 - Flipbook - Page 32
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
32
Covid-19 and Pandemic Preparedness
Emergency Use Authorization rollback
The Covid-19 Pandemic has impacted the world in a way that no
one could have predicted and required all stakeholders to step up to
confront the many challenges that emerged, including manufacturers,
health care providers, government agencies and entities who never
envisioned themselves as life sciences companies.
Manufacturers from many industry sectors responded and developed
products to contribute to the pandemic response and the FDA
leveraged rarely used emergency use authorization (EUA) and
enforcement discretion policies across technologies to bring much
needed personal protective equipment (PPE) and medical devices to
the market. Now that we are trying to return to normal, how do we
handle the impressive number of products that were released under
emergency use pathways?
Companies were permitted to market products under EUAs and
enforcement discretion for the duration of the public health emergency
without obtaining the premarket clearances or approvals that are
typically required. Because they are not marketed under a full approval,
their market authorizations are limited in scope and duration. In
general, an EUA product’s special status terminates upon the public
health emergency coming to an end, a change in the approval status of
the product, or if there are other circumstances that make revocation
appropriate. Such “other” circumstances may include:
FDA is supposed to work with manufacturers to figure out the
appropriate disposition of products that were released under
emergency use. FDA has started the process of revoking some
authorizations for example due to how ubiquitous they now are in
the marketplace (e.g., Non-NIOSH-Approved or Decontaminated
Disposable Respirators) and the launch of other authorized products
with superior performance as is the case with some Covid-19 tests.
FDA’s guidance indicates that products must be cleared or approved
to be marketed after the emergency declaration terminates and
companies will need to be prepared for that day to come . . . and
come it will. For those companies who have already submitted their
application for full marketing authorization, FDA has indicated
informally that it will not require companies to withdraw products
that have already been released while the application is pending. For
those companies that have not yet submitted and/or do not have
plans to submit, they should be prepared for the possibility that FDA
may well demand that products released during the pandemic be
withdrawn once the public health emergency comes to an end. Either
way, as we are emerging from the pandemic, now is the time for
companies to start to plan for the next phase of operations.
• S
ignificant adverse inspectional findings;
• R
eports of adverse events (number or severity) linked to,
or suspected of being caused by, the EUA product;
• P
roduct failure; or product ineffectiveness (such as newly emerging
data that may contribute to revision of the FDA's initial conclusion
that the product “may be effective” for its intended purpose under
the EUA), among other things;
• C
ompany proactively requests that FDA withdraw the EUA;
• U
mbrella revocation; and
• F
ailure to follow requirements mandated in the Emergency Use
Authorization letter.
Mike Heyl
Partner, Washington, D.C.
Jodi Scott
Partner, Denver
