The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn.
Hahn noted that the agency streamlined some of its processes to spur the development of potential COVID-19 treatments, including taking a fresh look at the design and running of clinical trials. For example, the FDA, the National Institutes of Health (NIH) and pharma developed a master protocol that could be used for multiple trials to enable research on more than one treatment at a time. The agency has also used expanded access to serve patients that cannot take part in trials, he said.
“Many of the permanent changes that we will implement really represent an acceleration of where we were headed before,” he said at a virtual event hosted by the Alliance for a Stronger FDA.
For example, decentralized trials — which use telemedicine and local healthcare providers — were crucial for some COVID-19 product studies, Hahn said. Researchers have largely been forced to use them in some form to continue trials during the health crisis. Experts in the research industry have expressed hope throughout the pandemic that remote methods will become more widely adopted in the future clinical landscape, he said.
The FDA’s response to the pandemic has also embraced the use of real-world evidence, which it has worked for years to incorporate into evaluations of drug and device safety and effectiveness. Hahn said that confidence in using real-world evidence in product decisions will grow as the agency gains more experience with it.
“I am committed to making sure that some of the lessons learned from managing this pandemic will lead to permanent improvements at the FDA in processes and policies,” he said. “And to the extent that we identified unnecessary barriers, we will remove them,” he said.
The commissioner said that he has directed agency staff to evaluate what has been learned so far in handling the outbreak and to pinpoint what changes may be required for greater regulatory efficiency going forward.
“To the extent that the 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,” he said.
Hahn also addressed Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Center for Biologics Evaluation and Research (CBER) Director Peter Marks’ involvement in the administration’s Operation Warp Speed project, which some worried posed conflict of interest risks. The commissioner said that Woodcock has temporarily stepped down as the head of CDER to focus on running the therapeutics initiative for Operation Warp Speed, while Marks remains at the helm of CBER and has departed Operation Warp Speed.
The commissioner explained that both Marks, Woodcock and he “will maintain our regulatory independence.”
“Janet [Woodcock] will not participate in the regulatory decisions around therapeutics and Peter and I will stay outside of any decision-making that Operation Warp Speed has to make with respect to medical products so that we can maintain our independence," Hahn said. — James Miessler