How healthcare organizations need to plan for the expiration of EUAs
On Jan. 31, 2020, then Secretary of Health and Human Services (HHS) Alex Azar declared the coronavirus a public health emergency, and on March 27, there was a second declaration that authorized the emergency use of drugs and biological products during the pandemic.* By law, these declarations enabled the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) of an unapproved product or use of an approved product, provided that certain criteria were met. This lifesaving strategy allowed the U.S. to quickly develop solutions for product shortages and new methods for lab testing, treatments and vaccines.
Since the start of the pandemic, the FDA issued EUAs or granted full marketing authorization to almost 1,300 medical devices for COVID-19. These EUAs offered a way forward that has been much faster than the typical, historically years-long process for standard FDA approvals. But something else sets them apart: EUAs are only temporary.
While health experts can’t be sure when we’ll be on the other side of the COVID-19 pandemic, they say the time to think about life after the pandemic is now.
In March 2020, the Centers for Disease Control and Prevention (CDC) was first to apply for an EUA for in vitro COVID-19 testing. “Initially, we only had one test that was given to the Department of Health from the CDC, which took three or four days to get results. We would sit there paralyzed with fear while the patient was in isolation,” says HealthTrust Physician Advisor S. Shaefer Spires, M.D., Assistant Professor of Medicine and Infectious Disease Specialist at Duke University School of Medicine. “Once companies were able to get EUAs for testing, the supply was no longer limited. The EUA process really shows that the FDA did its best to become versatile in this pandemic when we needed to think fast.”
With new vaccines, the FDA typically requires at least six months of safety data produced from clinical trials. With the EUA for the COVID-19 vaccines, only two months of safety data was required. “History shows that regarding vaccine trials, the overwhelming majority of adverse effects occur within the first two months of administration. Therefore, the FDA felt that only two months was needed for this particular scenario,” explains Dr. Spires.
EUAs also cost a lot less to pursue. “Following patients for six months after they get their trial vaccines costs significantly more money and takes a lot more resources and time,” Dr. Spires adds.
A fluid situation
However, while EUAs were a quick and efficient way to battle a raging pandemic, they also required that healthcare organizations remain nimble. “As with everything surrounding the pandemic, expertise is developed as experts research and learn,” says Karen Bush, MSN, FNP, BC, NCRP, Director of Clinical Research & Education at HealthTrust. As the pandemic has continued, clinicians learned more about the virus, its variants and patient reactions to care. This requires the constant evaluation and reevaluation of products that have EUA approval.
For example, not all EUA-approved facemasks are approved by the National Institute for Occupational Safety and Health (NIOSH), the regulatory body that typically authorizes them, so they will ultimately need to be reassessed.
In addition, some masks were taken off the EUA-approved list due to potential safety risks.
“We’ve also seen a lot of changes with decontamination products,” adds Bush. The FDA created a broad EUA for some disinfection and air purifiers, and as long as products met specific criteria, they were considered approved under this umbrella. But the details are important. “With N95 masks, for example, there are specific decontamination instructions. Some masks need to go back to the same user, while others can be used by anyone after decontaminating them. It’s not the same for every mask and decontamination system.”
In addition, some lab diagnostics, specifically antibody tests, were approved for EUA use early in the pandemic and had to be revoked—underscoring the need for clinicians to be diligent when using these products. “It’s important to understand the efficacy data behind these tests when it comes to a true positive and a false positive, and how to interpret the technology that you’re using,” says Dr. Spires. “When it comes to EUA products, healthcare facilities should ensure that they’re evaluating their options with intention and diligence and talking to their experts before spending any money on tests.”
Post-pandemic prep starts now
EUAs will end once the pandemic ends. However, the government is not required to give health systems a heads up that the state of emergency is over. In 2010, when HHS declared H1N1 over, the CDC sent notice that, effective immediately, the drug Peramivir, which was being used to treat H1N1 patients under an EUA, was to be destroyed, and no new doses would be created. There was no grace period.
COVID-19 is much more wide-ranging than H1N1 was, so the hope is there will be some forewarning. “So much of our healthcare infrastructure is based on EUAs at this point for COVID patients,” explains Dr. Spires. Either way, there’s reason to plan ahead. “Now is the time to start thinking about what products we can plan to substitute,” he adds.
Bush agrees. “Health systems should be asking themselves if they have a process for monitoring EUA products, and if not, they need to start planning,” she says.
In fact, the FDA is starting to show signs that it is scaling back on EUAs. In March 2021, the FDA sent notice that it would no longer be reviewing requests and adding new respirator models, which are the non-NIOSH-approved N95 masks. “This is a signal that we probably have enough and don’t need to add any more to the list,” says Bush. “It makes you wonder if this is a sign of a pivot—that perhaps moving forward, we aren’t seeing as much need for N95 masks and have adequate supply.”
Making the switch
Products with expiring EUAs are wide-ranging and could have a huge impact, starting with the most basic personal protective equipment (PPE). “Hospitals will likely have a challenge dealing with EUAs for PPE,” Dr. Spires notes. “Early in the pandemic, there was an urgent need for decontamination devices for masks, so people were cranking these things out using hydrogen peroxide vapor, UV light and homegrown innovations. Hospitals will have to figure out how to decontaminate products moving forward or ramp up their supply of PPE.”
Dr. Spires notes that some organizations that purchased EUA equipment will also have to consider what to do with expensive items that will no longer be approved for use. “Some companies will choose to pursue full FDA licensure for their products, but many won’t because of the intensive costs and resources needed,” he explains.
For example, “Early on, hospitals asked car companies to make ventilators,” Dr. Spires adds. “It’s good that the FDA had this EUA process to get products authorized quickly, but Toyota is not going to apply for the full approval of licensure. A ventilator is a class 3 risk because it supports human life, so I don’t expect the FDA to soften the approval process for that. The hope is that hospitals won’t have to waste the ventilators they’ve purchased.”
Where should healthcare organizations start? First, consider converting to FDA-approved products. “If you’re using a UV light device to decontaminate patient rooms and it was previously FDA approved, then continue using it,” explains Bush. “If not, think about what you’ll do with that device once the EUA goes away and what you’ll use to replace it.”
Then, proactively reach out to the manufacturers. “Contact them to see if they’re going to go for full approval,” says Dr. Spires. “If we have a lab-developed test and have to purchase the reagents, for example, we need to determine if the manufacturer will continue to make those reagents. At some point, manufacturers will stop creating them because the demand will die down. We need to be aware of this.”
Still, there is one EUA that is top of mind for all healthcare workers. “The biggest concern for clinicians is the vaccine receiving full licensure. We all know that’s the answer to getting this over with,” says Dr. Spires, who is optimistic that it’s not far off. “I think we’re going to see the vaccine manufacturers for the three approved vaccines all go for full approval in 2021. I imagine that HHS will give them a heads up that they are thinking of declaring the pandemic over, and then we will see these companies start flooding resources toward getting full FDA approval.”
- Assemble your team. Karen Bush, MSN, FNP, BC, NCRP, Director of Clinical Research & Education at HealthTrust, recommends creating a multidisciplinary team that includes supply chain, environmental services, nursing, respiratory therapy, physician, pharmacy and executive membership.
- Take inventory. Create a process for how you will inventory and keep track of all EUA-approved products in use at your facility, and how often they are used.
- Monitor the FDA for updates. The FDA regularly sends out and posts updates to EUAs on its website and via e-newsletters to a listserv. Assign an individual or team to check and track changes to EUA products and communicate these changes to the appropriate people in your health system.
- Look at each product’s use and what might need to change. Ask questions such as:
- If a product is previously FDA-approved, can it be used in the capacity that you are currently using it?
- Does it need to be reconfigured to function as previously approved?
- What resources are needed for this conversion?
- If a product is EUA-approved, is the capacity in which you were using it still necessary?
- If the product will be retired from service, will it be disposed of or stored for future use?
- Are there any environmental or expiration concerns?
- Spread the word. If you’re part of a larger organization with lots of resources to track updates, reach out to your community partners who may not have the same bandwidth. Add them to your communications so they can be in the know about product updates, for the greater good.
- Call on your manufacturers and suppliers. Ask if they plan to pursue full FDA approval for their products or devices. Also, know that sometimes manufacturers may not fully understand what EUAs mean and the nuances of the regulations.
- Take advantage of subject matter experts. Call on your infectious disease specialists and other experts to review and investigate how you are using a product to ensure it is safe, acceptable and within regulation.
* UPDATE: On April 15, 2021, HHS Secretary Xavier Becerra renewed the federal Public Health Emergency for another 90-day period. The current PHE is scheduled to expire on July 19, 2021. However, on Jan. 22, 2021, the acting HHS secretary sent a letter to governors that indicated the Biden administration would continue renewing the federal PHE at least through the end of the year. The administration can choose to let it expire early but has said it will provide 60 days’ notice before it does so.Share Email CDC, COVID-19, EUA, FDA Updates, Q3 2021, Regulations