Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration (FDA), released an update regarding the supply chain of medical products and food and the FDA’s work 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. They 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.
The latest actions include:
Medical Devices
The situation with personal protective equipment (PPE) is very concerning. The FDA is taking every possible action they can, and the situation is dire for many healthcare facilities. The agency, 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.
There are shortages of respirators and the FDA has issued Emergency Use Authorizations (EUA) covering certain respirators to enable them to be used in healthcare 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 healthcare professionals.
The FDA is working on mitigation strategies for other types of personal protective equipment including surgical masks, gowns, and gloves. The agency is working with textile manufacturers, including clothing designers, about how to 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.
The FDA is 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 they 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 they’ve already determined, among other criteria, that the known and potential benefits of these products being used in healthcare 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.
The FDA further recognizes the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to healthcare facilities and have issued 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. The FDA anticipates 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, [email protected]. 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
The FDA continues 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. They 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.
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, they 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. They are also aware that a number of states have taken action to limit the dispensing of certain drugs, including chloroquine and hydroxychlorquine.
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.
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. The FDA continues 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.
Human and Animal Food
Overall, retail supply chains remain strong, and the FDA is 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.
