FDA Commissioner Stephen Hahn, M.D., has vowed to permanently adopt COVID-19-driven changes that make reviews and authorizations faster. Hahn made the commitment in a speech that called on the FDA to learn from the crisis to enact lasting policies that accelerate drug development.
Fresh from a 14-day quarantine necessitated by contact with someone infected with COVID-19, Hahn set out how the FDA responded to the crisis and how it will shape the future of the agency. While acknowledging that the FDA’s response to the pandemic encountered some “hiccups,” Hahn sees positives that support the accelerated transformation of the agency under his leadership.
“To the extent that innovations and adaptations we implemented during the pandemic crisis worked and would be appropriate to implement outside of a pandemic situation, we will incorporate them into standard FDA procedures. And to the extent that we identified unnecessary barriers, we will remove them. This is one of my top priorities. Permanent change, where needed, will take place,” Hahn said.
The commitment is partly a reflection of Hahn’s belief that the crisis exposed processes and policies that need changing. Hahn has tasked his staff with identifying changes the FDA can make to prepare for future pandemics and improve the overall efficiency of its operations. Drug developers stand to benefit from the changes.
“In facilitating the development of new treatments, we streamlined some of our processes. Anything that enables quicker reviews and authorizations, we will seek to make permanent,” Hahn said.
The pandemic could also lead to lasting changes in how drug developers gather evidence to support submissions to the FDA. Hahn identified decentralized clinical trials and real-world data as two areas that could be turbocharged by the pandemic.
In each case, the FDA and industry were moving toward greater use of the approaches prior to the coronavirus outbreak. COVID-19 has driven greater use of each approach to enable clinical trials to take place at a time of social distancing and accelerate the process of learning about interventions and the diseases they address. In doing so, the crisis is helping validate the approaches.
“The more experience we have with real-world evidence, the more confidence we will have in using it for product decisions,” Hahn said.
Hahn also picked out the FDA’s work with the National Institutes of Health and industry to implement a master protocol that supports the simultaneous clinical testing of multiple COVID-19 drugs as an idea that could take off after the pandemic.