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The changing landscape for FDA EUAs

Posted on by Congenius

An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) as required during public health emergencies. 

Over the last two decades, the public has faced major health threats spanning anthrax attacks, Zika virus, Ebola virus, MERS, H1N1 and most recently, COVID-19, all of which have impacted the evolution of EUAs.

Our Head of Regulatory Corinne Larke looks at the history behind EUAs, the current FDA requirements for EUA applications and ultimately, how COVID-19 has changed the landscape for FDA EUAs moving forward…

The history behind EUAs

Whilst EUAs are a lot more prevalent during the COVID-19 pandemic, they were also used for devices and drugs combatting the Zika epidemic in 2016, the Ebola epidemic of 2013-14, the 2012 MERS Coronavirus, the H1N1 Swine Flu pandemic in 2009, as well as for the Anthrax Vaccine following the anthrax attacks of September 2001.

Before the implementation of EUAs, the only way to use an unapproved or off label device or drug in the US was via an Investigational Device Exemption (IDE) or Investigational New Drug Application (IND). This process can prove both lengthy and burdensome however, and its use is limited to drug or device investigations.

Thoughts on the need for a parallel track to the more formal FDA approval process actually emerged long before EUAs were established – potentially as far back as the 1950’s Thalidomide crisis, where a morning sickness drug was found to cause severe birth defects in over 10,000 babies.

The AIDS crisis in the 1980s sparked a call for investigational Drug-Drug Interaction (DDI) studies to be used on eligible patients while the treatment was still at clinical study stage, which elevated the discussion on creating a different pathway for emergency use authorisation to higher political levels in the US.

The anthrax attacks that followed the terrorist acts of September 11, 2001, gave new urgency to the need for a faster authorisation process in case of an emergency. After several US media offices and two Democratic Senators were targeted with anthrax, the Department of Health and Human Services started working on a less burdensome process for authorising the use of medical devices during a national emergency.

This resulted in the inclusion of the EUA into Section 546 of the Federal Food, Drug and Cosmetic Act (FD&C) in 2004. In 2013 it was incorporated into the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) which allows the off label use or expedited authorisation of an already approved or cleared device, biologic or drug, in the case of a declared emergency.

What are the FDA requirements for EUAs?

Since EUAs are specifically tied to emergencies, generally, a public health emergency must first be determined and declared by the Department of Health and Human Services. After this declaration, companies can start working with the FDA to prepare and submit an EUA request. However, if there is significant potential of an emergency, based on a requisite EUA declaration by the HHS, the FDA could issue EUAs in preparation for such an emergency.

Once a request is submitted, the FDA undergo their review and approval. Unlike a 510(k) submission, the FDA is not bound to specific review timelines for an EUA, and furthermore,  EUAs will no longer be granted once the declared emergency ends. The FDA may even decide to revoke an EUA before the official emergency end should they deem this necessary.  

Therefore, depending on the situation, a manufacturer may decide to pursue a 510(k) at the same time as their EUA request, or shortly after the EUA is granted, to ensure that their device can continue to be marketed after a public health emergency concludes. Due to the lack of specificity regarding EUA review timelines, a manufacturer may also decide to pursue a 510(k) instead of an EUA in case of public health emergency.

To be able to qualify for an EUA during a public health emergency, a device must be considered by the FDA as safe and effective based on the available scientific evidence, and there must not be any sufficient adequate alternatives available which have been cleared or approved by the FDA through normal channels.

Preparing an EUA

In preparation of an EUA, FDA strongly recommends that:

  • Manufacturers submit their data for a pre-EUA submission, in the style of medical device pre-submissions and that;
  • EUA requests include a summary of available scientific evidence regarding the safety and effectiveness of the device, as well as the risks and benefits and any approved alternatives to the device

The structure for an EUA is less prescriptive than for a 510(k) or PMA. The key information to incorporate into an EUA application includes:

  • A description of the need for the product, how the EUA would address unmet needs, and what alternative products are already available
  • A device and it’s intended use description
  • The device’s FDA approval status
  • Available safety and effectiveness data
  • A risks and benefits discussion
  • Material, manufacturing, and labelling information

How COVID-19 changed the EUA process

During the first years of its existence, the EUA was rarely used. It wasn’t until the H1N1 Swine Flu outbreak in 2009 that an increase in use frequency became apparent.

But in February 2020, the HHS’ declaration of the COVID-19 pandemic as a national health emergency paved the way for a huge boost in EUA requests. Whilst it felt like a pause button was pressed on so many aspects of our lives in March 2020, a proverbial storm of activity swept through many healthcare manufacturers as well as the FDA.

Since the beginning of the pandemic, the FDA has granted more than 600 EUAs, to ensure access to ventilators, tests, vaccines, therapeutics or personal protective equipment for US patients and healthcare personnel. By comparison, approximately just 20 EUAs were issued during the 2009 H1N1 outbreak.

To combat the shortage of resources to tackle the pandemic, the FDA even issued several so-called “Umbrella EUAs”, which allowed tests and personal protective equipment of certain categories to be brought to the market before they were reviewed case by case.

Whilst faster access to life-saving treatment and equipment is largely positive, the significant increase in EUAs was not without controversy. Given that the FDA Commissioner is appointed by the President of the United States, the Agency is answerable to a political body. There was criticism relating to the influence of Donald Trump and his administration regarding FDA decisions to grant certain EUAs, and political or personal motives of the President and his administration were suspected. This poses the broader question of how political officials are influencing FDA decisions, and whether the line between political interests and technical expertise and science is becoming increasingly blurred.

Interestingly, in recent months the FDA has been revisiting some of its decisions, including withdrawing several Umbrella EUAs and some EUAs which may have been issued under pressure from the Trump administration. EUAs for some imported respirators, PPE devices, and PPE decontamination systems were revoked in July, and a number of COVID-19 IVD tests had their EUA status revoked in August. You can read the FDA’s review of its lessons learned here.

Looking ahead: What does the future look like for FDA EUAs?

Whilst evaluating the impact of the vast number of EUAs issued during the COVID-19 pandemic, some experts contemplate whether this approach has set a precedent that may challenge the FDA to uphold evidence-based approvals in future emergency situations. Others examine the implications of quicker access for patients and clinicians to devices and drugs for the US healthcare and economy, taking the FDA’s response to COVID-19 as an enlightening case study.

What we can be sure of though, is that the FDA will continue to evolve and adapt their approach as the pandemic enters into its next stages.  

Do you have an EUA-related challenge? Our Regulatory team is ready and happy to help. Simply get in touch to start a conversation.

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