Emergency Use Authorization: Benefits and Risks

Over the last few months, The Food and Drug Administration (FDA) has spent more time than usual approving Emergency Use Authorization (EUA) authority for medical organizations across the U.S. Fast-approving more than 100 medical device and testing kits in such a short amount of time is hardly standard practice for the FDA. Yet these FDA approvals during COVID-19 are essential to protecting public health and safety.

 

EUAs come with their own set of benefits and risks, as well as a detailed process to determine whether the devices in question are fit for use in emergency situations. As a result, it’s important to understand what this process is and how the regulatory standards apply during unprecedented times.


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What Is Emergency Use Authorization?

Emergency Use Authorization is a program that allows health professionals to temporarily use an unapproved medication, medical device or medical procedure to save people’s lives. This law exists under section 564 of the Food, Drug and Cosmetic Act and is designed to protect medical patients with life-threatening illnesses who lack access to alternative treatment.

 

Right now, the EUA authority is prevalent thanks to the widespread threat of COVID-19, which has infected almost 10 million people worldwide and claimed more than 400,000 lives to date. The FDA has granted EUA approvals for a variety of items, including remdesivir, hydroxychloroquine, new testing methods and more.

 

Before a company can receive approval for the EUA of a treatment, certain criteria must be met. First, there needs to be a state of emergency, such as a threat to public health like COVID-19. The secretary of homeland security often makes this decision if there is a military threat, while the secretary of health and human services can declare a public health emergency.

 

Once the proper officials have declared a state of emergency, the FDA can decide whether or not to approve a drug, device or procedure based on:

  • The effectiveness of the unapproved product
  • The availability of alternatives
  • Risk to benefit analyses

For example, if a device is still being tested as a test kit for COVID-19 and it’s the only option to maintain supply, it can receive temporary approval from the FDA. This condition can apply if no other successful options are available or if product shortages are preventing care to patients in need.

 

What Are the Benefits and Risks of Emergency Use Authorization?

The main benefit of an EUA is that it has the potential to save lives during public health emergencies by easing some of the restrictions under 510(k) submissions. It’s a temporary measure, giving health professionals the ability to administer unconventional treatment and go through the steps to have it long-term approved later.

 

Before approving a treatment for the EUA program, the FDA needs to conduct an analysis of the benefits and risks of Emergency Use Authorization. This process is a challenging one because of the discrepancies between cases. For example, one device might be in a different stage of approval than another, while the information companies send in can vary based on the device.

 

Weighing the positive effects of the device against the possible risks to patients can be difficult too. Healthcare manufacturers may be working with minimal or inconclusive data while seeking fast approval for their products. This situation puts heavy pressure on officials to make smart, informed decisions that will save as many people as possible.

 

The FDA is currently working to update and address new policies so that manufacturers can continue to roll out life-saving assets and maximize availability. Some of the guidelines available are those that were left over after Ebola and the SARS epidemic years ago. For instance, the FDA offers guidance for absenteeism to account for people on sick leave. Guidelines also cover ways to handle social distancing while still adhering to regulations and maintaining productivity.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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