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How FDA Ramped Up COVID-19 Treatment Approvals

Leaders across the Center for Drug Evaluation and Research are applying lessons learned from the pandemic on its response to therapies for emerging variants.

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When COVID-19 was declared a national emergency, the Food and Drug Administration had to act quickly on its oversight responsibilities around the sudden need for new testing, equipment and, ultimately, vaccines. Especially in the face of new variants, the Center for Drug Evaluation and Research (CDER) is taking lessons learned during the pandemic to prioritize upcoming needs and areas of improvement.

One major way the department was able to scale up its processes was through its Coronavirus Treatment Acceleration Program (CTAP) launched in April 2020 to accelerate the development of therapeutics in collaboration with the Center for Biologics Evaluation and Research (CBER).

“As part of this program, we used all available tools to engage with developers and also to exercise regulatory flexibility to the full extent that we could,” CDER Director Patrizia Cavazzoni said during FDA’s annual conference for industry regulatory education. “Early engagement and communication with our developers as well as regulatory flexibility” was essential to the launch and success of CTAP, she added.

To date, CDER has authorized 10 COVID-19 treatments for emergency use under the program, with more than 620 drug development programs in planning stages and more than 460 trials of potential therapies reviewed.

“These are novel treatments, so this gives you an idea of how fast the development played itself out, and we are really talking about developing drugs in a matter of months rather than years,” Cavazzoni said.

While the regulatory and decision-making processes did not change to accommodate that timeline, Cavazzoni noted that CDER still relied on science and data to make those faster decisions. Plus, the “work horse” of the COVID-19 therapeutics have been the monoclonal antibody (mAb) therapies.

“We now have three drugs that are authorized for mild to moderate COVID-19 early in the disease stage before hospitalization. These drugs have shown a substantial decrease in hospitalization in patients with COVID-19,” Cavazzoni said.

CDER also expedited the development of medical countermeasures (MCMs), said Regulatory Affairs, Counter-Terrorism and Emergency Coordination Staff Associate Director Andrea Gormley, whose office falls under CDER.

Gormley’s office often collaborates with other departments and agencies like the Defense Department, Centers for Disease Control and Prevention, and the National Institutes of Health to support national emergency preparedness and response. The office has also served as a consultant for MCM developers and CDER to facilitate the development of new tools to diagnose, prevent and treat conditions associated with COVID-19.

“In any kind of public health emergency, our main goal at CDER is to assemble the right people to make decisions [and] work with our U.S. government partners to collect information … to really develop a data-driven strategic response on how to address a pandemic when there is a threat to public health,” said Kelly Ngan, team leader of project management and emergency coordination in the office.

Immediately following the onset of COVID-19, CDER honed in on supply chain security and shortages. The center took a proactive approach to managing shortages and collaborated with other health agencies like CDC to tackle supply chain issues and prevent drug shortages.

“We really did not wait for companies to notify us of potential problems with supplies we actually reached out to all manufacturers in February of 2020 as part of our forward-leaning approach to identify potential disruptions or shortages,” Ngan said.

Throughout its pandemic response, CDER said that there are new takeaways that the center has learned and can apply to future public health emergencies. Cavazzoni said that partners should engage early and often with CDER’s scientific staff to develop investigational programs, and they should also begin early discussions about chemistry, manufacturing and controls.

“Obviously when we’re trying to accelerate the availability of therapeutics, having to deal with facilities that we have never seen before … have in some instances been limiting our ability,” Cavazzoni said.

CDER is applying similar approaches amid emerging COVID-19 variants. FDA has already seen utility decreases in current COVID-19 treatments when they are applied to some of the existing variants, but there is still work to be done.

“The issue of emerging variants is very relevant, not only to diagnostics and to vaccines, but also to therapeutics,” Cavazzoni said. “We really have to take a dynamic approach to continuing to do surveillance of these mAbs against emerging variants to determine if some of these variants may be resistant to mAbs.”

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