SILVER SPRING, Md.,
March 28, 2020 /PRNewswire/ -- During
this COVID-19 pandemic, the FDA is working around the clock to make
sure that Americans have access to safe food and medical products.
The agency is continuously examining the global supply chain to
identify any concerns and assess the availability of the products
Americans need most. We are also partnering with the Federal
Emergency Management Agency (FEMA) on supply chain issues,
including importation of needed medical products to support the
U.S. response. Here is a status update and details on some of the
latest actions we have taken:
Medical Devices
As a doctor, the situation with personal protective equipment
(PPE) is very concerning. We are taking every possible action we
can, but we know the situation is dire for many health care
facilities. We want to share that the FDA, along with the private
sector, FEMA and all of the U.S. Government, are working around the
clock to address this issue as quickly as possible.
We are aware of shortages of respirators and have issued
Emergency Use Authorizations (EUA) covering certain respirators to
enable them to be used in health care settings. Via the EUA and the
shortages mailbox, the team has directed stakeholders to CDC's
strategies for optimizing respirator supply and recommendations on
the use of expired respirators.
Most recently, the FDA issued an EUA to help increase the supply
of filtering facepiece respirators by authorizing the use of
certain imported disposable respirators that are not National
Institute for Occupational Safety and Health (NIOSH)-approved for
use by health care professionals. We are continuing to work on
strategies to increase the availability of these devices.
We are also working on mitigation strategies for other types of
personal protective equipment including surgical masks, gowns, and
gloves. We have issued information to health care providers and
have provided recommended conservation strategies for these
important PPE.
We are working with textile manufacturers, including clothing
designers, about how we can repurpose their manufacturing product
lines to put them to use to make masks. These masks can be used for
surgical or other isolation procedures, as the benefits of using
them outweigh the risks under current circumstances.
We are providing maximum regulatory flexibility where we
can.
We are also open to importing PPE and other devices and have
provided instructions to manufacturers to help us implement this
necessity appropriately. The agency is taking steps to
facilitate importation of PPE into the U.S. and we are ready and
available to engage with importers to minimize disruptions during
the importing process. This means that when products come in
from overseas, their authorization via our EUA authority allows
them to quickly enter the country. These products aren't hindered
from entry and we've already determined, among other criteria, that
the known and potential benefits of these products being used in
health care settings outweigh the known and potential risks.
The FDA has reached out to more than 1,000 device manufacturing
sites worldwide, focusing on essential devices. The outreach
thus far has focused on two main types of essential devices: those
that are in high demand due to the pandemic outbreak, such as PPE
and ventilators, and devices that may be prone to potential
shortage if there is a supply disruption.
We further recognize the need for ventilators, ventilator
accessories, and other respiratory devices may outpace the supply
available to health care facilities. We have issued an immediately
in effect guidance outlining a policy intended to help increase
availability of ventilators and their accessories as well as other
respiratory devices. In addition to the guidance, the FDA has
issued an EUA that authorizes the emergency use of ventilators,
anesthesia gas machines modified for use as ventilators, and
positive pressure breathing devices modified for use as ventilators
(collectively referred to as "ventilators"), ventilator tubing
connectors, and ventilator accessories, that FDA determines meet
the specified criteria for safety, performance and labeling. We
anticipate this action will increase the number of patients who can
have access to ventilators or similar machines for respiratory
distress, which is important for critically ill COVID-19
patients
As with prior emergencies, the FDA has taken proactive steps to
establish and remain in contact with medical device manufacturers
and others in the supply chain, including hospitals and group
purchasing organizations. The agency also encourages manufacturers
and healthcare facilities to report any supply disruptions to the
device shortages mailbox, deviceshortages@fda.hhs.gov. This mailbox
is closely monitored and has proven to be a valuable surveillance
resource to augment FDA efforts to detect and mitigate potential
supply chain disruption.
Human Drugs & Biologics and Animal Drugs
We continue to work closely with manufacturers to make sure that
they continue to notify the FDA, as early as possible, of a
permanent discontinuance or any interruption in manufacturing that
is likely to lead to a disruption in supply. This communication and
the full cooperation of companies providing specific and necessary
information is imperative in order for us to have an accurate
understanding of the supply landscape and work to take proactive
steps to mitigate shortages. To help human drug manufacturers
submit timely and informative notifications, the agency is
publishing a guidance for immediate implementation about the
importance of these notifications, the timelines for manufacturers
to follow when notifying the FDA, and the details for them to
provide about the discontinuance or interruption of manufacturing.
We recognize that while some supply disruptions and shortages
cannot be predicted or prevented, early communication and detailed
notifications from manufacturers to the agency play a significant
role in decreasing their incidence, impact, and duration.
Our efforts with federal partners and pharmacy groups continue
to establish mitigation strategies and prevent long-term supply
shortages. At this time, where there is an acute demand for certain
products and disruption in the supply chain, we are taking
proactive steps to make sure that patients can access the
medications that are medically appropriate and necessary. Some
retail pharmacies have begun implementing policies designed to
limit the overprescribing and overdispensing of certain medications
in order to preserve the supply nationally. We are also aware that
a number of states have taken action to limit the dispensing of
certain drugs, including chloroquine and
hydroxychlorquine.
Our public drug shortages lists are up-to-date with human and
animal drugs and biological products that we have determined to be
in shortage. These shortages are not all results of COVID-19, with
many existing prior to the pandemic as results of market changes
and supply challenges. We are updating these lists regularly and
communicating in real-time so that patients and healthcare
providers have the most current information on product shortages in
the U.S.
The agency has decided it does not intend to object to
registered outsourcing facilities using hydroxychloroquine. Despite
this action, it is important to note that there are currently no
FDA-approved therapeutics or drugs to treat, cure or prevent
COVID-19; however, there are FDA-approved treatments that may help
ease the symptoms of COVID-19.
Lastly, we appreciate industry's willingness to help supply hand
sanitizer to the market to meet the increasing demand for
alcohol-based hand sanitizers during the COVID-19 pandemic.
As part of our commitment to providing timely guidance to support
continuity and response efforts during this pandemic, the
agency has published guidances to provide flexibility to
help meet the demand for hand sanitizer.
Blood Supply
Blood supplies have been dramatically reduced due to the
implementation of social distancing and the cancellation of blood
drives. Maintaining adequate levels of our nation's blood
supply is critical. People who donate blood are equivalent to
those who work in critical infrastructure industries. We
continue to encourage individuals who are healthy and able to
donate blood. Donating is safe and takes only a little of
your time. At many blood donations centers, those who are
interested in donating can make an appointment to minimize the time
it takes to donate blood. Contact information for local blood
collection sites and for scheduling appointments can be found on
FDA's website.
Human and Animal Food
Overall, retail supply chains remain strong, and we are working
with food manufacturers and grocery stores to closely monitor the
human and animal food supply chain for any shortages. The agency is
in close contact with industry and its trade associations, which
are in touch with their members about supply chain issues.
Food production and manufacturing – for both people and animals
– are dispersed throughout the U.S., and we are pleased to report
there are currently no widespread disruptions reported in the
supply chain. Empty grocery shelves are largely due to
unprecedented demand – not a lack of capacity to produce, process
and deliver. Manufacturers and retailers are working around
the clock to replenish shelves.
The same is true for animal food. The FDA is monitoring the
availability of foods for livestock and pets. There are no
shortages, and no current disruptions in the pet and livestock food
supply chain.
I am grateful to workers in the food and agriculture sector
filling critical and essential roles within communities. Their
ability to continue to work during periods of community
restrictions, social distancing, and closure orders, among others,
is crucial to community continuity and community resilience. This
was reinforced by DHS in its Guidance on the Essential Critical
Infrastructure Workforce: Ensuring Community and National
Resilience in COVID-19.
Veterinary Medicine
Our Center for Veterinary Medicine is working with veterinary
stakeholder groups to alert veterinary professionals to adopt PPE
conservation strategies to make the most of their current supply of
items, such as masks and gloves. We're also encouraging the
postponement of non-urgent/routine veterinary medical procedures
during this pandemic. In addition, we have been coordinating with
veterinary medical supply manufacturers and distributors to explore
how certain veterinary medical supplies, such as sterile swabs, and
devices, such as ventilators, could be redirected to address
critical shortages in human health care.
Additional Resources:
- FDA: Coronavirus Disease 2019 (COVID-19)
- Drug Shortages
- Biologics Shortages
- FAQs on Diagnostic Testing for SARS-CoV 2
Media Contact: Jeremy
Kahn, 301-796-8671
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
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SOURCE U.S. Food and Drug Administration