Emergency Use Authorization: What We’ve Learned Bringing COVID-19 Therapies to Market

In one year, the United States surpassed 29 million infections from COVID-19, and more than 538,000 deaths. In less than 365 days, we lost more American lives from the Coronavirus than the number of US soldiers lost during the four years of World War II. It has been a year of grief, pain, loss, and lockdown. It has been a year of lessons learned.

When COVID-19 was declared a public health emergency last March, the United States had to act promptly as hospitalization rates skyrocketed nearly 800 percent in a matter of weeks.¹ In response, the global pharmaceutical supply chain quickly developed and delivered much-needed COVID-19 therapies for patients. After the appropriate research period, the United States Food and Drug Administration (FDA) began issuing Emergency Use Authorizations (EUA) for select pharmaceutical products. The EUA pathway, established in 2004, allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases like COVID-19, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. This process was a critical lever that the federal government was able to pull to provide immediate relief to patients suffering from COVID-19, especially in the hospital setting. Without the EUA pathway, the approval process for drugs to help COVID-19 patients could have taken a lot longer, if not years. And it’s still a pathway that manufacturers are evaluating to bring COVID-19 therapies to market today.

Because of this unique authorization process, eight COVID-19 therapies were reviewed and cleared to support patients in record time and there are even more in the pipeline today. In fact, according to numbers from the FDA’s Coronavirus Treatment Acceleration Program (CTAP), there are more than 610 COVID-19 drugs in the development planning stages and more than 450 in review with the FDA. With so many new COVID therapies awaiting approval, EUAs will continue to be a critical pathway for making new treatment options available to providers and patients as we continue to operate under this state of emergency. CTAP will remain an important program even once the state of emergency is lifted, positioning the industry to more efficiently address public health needs in the future.

With the advent of COVID-19 vaccines and more than 40 percent of Americans now fully vaccinated, there’s clearly a push to end the pandemic. However, the unfortunate truth is that COVID-19 will continue to loom over communities and the need for therapies will remain relevant. According to many pandemic experts, reaching herd immunity in the U.S. will continue to be an uphill battle. As new variants continue to emerge, we could anticipate COVID-19 outbreaks for years to come. Fortunately, we’ve learned a lot during the past year through EUA approvals and programs like CTAP about how to address global crises, giving us a better pathway to meet future needs.

Manufacturers looking to explore EUA for treatments of COVID-19, or generally looking to expedite launch once they receive approval, can apply lessons learned from the last year to set themselves, the supply chain, and, most importantly, patients up for success. Specifically, manufacturers should focus on: developing deep relationships with regulatory bodies and working closely with authorities on initial distribution and allocation plans; educating providers on product attributes and proper handling prior to approval; as well as, establishing open dialogue across the supply chain.

Partnering with the government

The United States government has become one of the most important stakeholders in the availability of COVID-19 therapies under EUA. When a therapy is authorized for emergency use, the government provides a higher level of oversight around these products, having a hand in decisions around distribution and allocation. This was particularly true for the initial therapies that received EUAs for COVID-19. As an example, Remdesivir (developed by Gilead and now known as Veklury) was one of the first COVID-19 products to become available. Veklury is indicated for the treatment of adults and children (at least 12 years of age) who are hospitalized with COVID-19. The federal government, through the U.S. Department of Health and Human Services, initially led decisions regarding distribution and allocation. This was because the government purchased a large portion of inventory and needed it to be shared equitably across the United States. Once the supply stabilized, the government transitioned the responsibilities back to the traditional commercial supply chain.

Manufacturers seeking EUA or expedited approval for COVID-related products and therapies in future crises should work closely with regulatory bodies early in the development process and clinical review stages to understand the role the government will play in the launch of each new product and engage with them accordingly. The critical questions manufacturers should ask and understand include: whether the government is purchasing the initial product inventory, if the government will own that inventory, and if so, what are the implications? Once manufacturers understand the government’s role, they will have a better idea of how to support their product’s launch and plan for future commercialization.

Educating sites of care

With typical product launches, it takes years of preparation. Manufacturers and pharmaceutical distributors have ample time to plan channel strategies and develop commercialization plans, while providers review and digest the therapy’s clinical trial, efficacy data, and other important information. With emergency-use authorizations, the pharmaceutical supply chain must do two to three years’ worth of work in only a few months to ensure innovative products can quickly get to the patients who need them.

Health systems and other sites of care are nimble, and they have long adapted to evolving treatment recommendations and the use of emerging therapies. However, even with the significant demand for new COVID-19 products, providers still need time to learn about the therapy, gain confidence in its safety and efficacy and understand how it should be implemented into their treatment plans and protocols. With an expedited process, it’s more important than ever that manufacturers’ education plans begin in tandem with the therapeutic development process. This ensures that, by the time a manufacturer is ready to truly launch and distribute its COVID-19 product, the sites of care that will administer it are familiar with it, understand its product attributes, and know how to correctly handle or store it.

Manufacturers are already finding success by providing regular, ongoing pipeline updates to providers or by developing educational one-pagers for new therapies. These one-pagers often contain answers to a providers’ most frequently asked questions about the product and how it should be used to treat patients. Hospitals, doctors' offices, clinics, and other care facilities feel more confident in implementing a product when they have been kept in the loop on clinical studies and patient outcomes from the very beginning and have the information they need at their fingertips. The early notice also gives providers more time to plan for implementing a product and understanding how it fits into established workflows.

Consistent & open communication

The most important key to success is creating a consistent and open forum for communication across all partners in the supply chain. This is the first time the EUA pathway has been used to address a national crisis of this scale and as expected, EUA guidance has and will continue to undergo updates. In fact, the latest update allows the FDA to decline EUA requests for COVID-19 vaccines from developers that have not yet met with the agency to discuss their product.As manufacturers, distributors, government officials, and providers continue optimizing how they work together, they’ve quickly realized that multi-directional communication is critical. Health systems and other sites of care must be able to communicate, in real-time, their concerns, evolving needs, and questions to manufacturers, government agencies, and distribution partners.

One thing the supply chain learned early in the pandemic was the need for manufacturers to establish weekly town halls and one-on-one calls with hospitals and doctors. These calls gave providers opportunities to ask questions and share inventory issues and concerns. They also helped manufacturers of EUA products and distributors understand the mindset of each site of care and shape certain distribution factors, such as allocation programs. For example, prior to COVID-19, allocation—which is used to cap orders of high-demand products that are in short supply to ensure proper access for all sites of care—was traditionally based on providers’ historical purchasing records. It was through open dialogue with hospitals and pharmacies, however, that AmerisourceBergen and its partners realized there was a need to develop a new allocation approach that took into account current stress on the site of care, the number of ICU patients, and its location in or out of a “hot zone.”

Ultimately, we know there will be more evolution required as the entire healthcare community and pharmaceutical supply chain continue to support patients in response to COVID-19 and beyond. But, so far, the supply chain has learned a lot from refining the process of bringing products to market through the EUA pathway. The pandemic has forced pharmaceutical companies of all sizes to work faster, smarter, more efficiently, and more collaboratively than ever before to meet hard deadlines. We expect manufacturers to launch COVID-19 products even faster than they did in 2020, working hand in hand with the FDA’s CTAP. If we apply the lessons we have learned, we can continue to make substantial progress in caring for COVID-19 patients, responding to new COVID outbreaks, and addressing future health emergencies—whatever they may be.

Reference

1. “Past Weekly Surveillance Reports.” COVID Data Tracker Weekly Review: Past Weekly Surveillance Reports, Centers for Disease Control and Prevention, www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/covid-view-past-summaries.html?Sort=Posted+Date%3A%3Adesc&Page=4.