The United States Food and Drug Administration (FDA) made several changes in response to the COVID-19 pandemic, and now FDA Commissioner Stephen Hahn has indicated that some of those changes can be expected to be made permanent. In a video uploaded to the FDA’s YouTube account, Dr. Hahn made the announcement, stating, “As this pandemic has evolved, it was clear to all of us that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic and I think the entire FDA team has now seen first-hand that we need to take a critical look at some of our processes and policies.”
Hahn started the video out by praising the staff and scientists at the FDA for all their hard work and adjustments they had to make. He noted that very quickly into realizing the pandemic was upon us, the FDA “immediately committed to facilitating efforts to develop diagnostic tests, treatments, and vaccines for the disease” and also highlighted efforts to “ensure continued access to necessary medical products” and seeking to prevent the sale of fraudulent products.
He also cited the fact that the agency was able to review and issue emergency use authorizations from medical devices for COVID-19 at an “incredibly fast pace” and work closely with companies that don’t often make medical devices but wanted to pitch in and help produce hand sanitizer, ventilators, or PPE. He further acknowledged that early in the crisis, the FDA “provided regulatory flexibility” for developers as outlined in agency policies as public health dictated increased testing capability.
Dr. Hahn said that many of the changes permanently implemented by the agency will “represent an acceleration of where we were headed before COVID-19,” with a focus on decentralized clinical trials, greater use of telemedicine in clinical trials, and work related to laboratory-developed tests. To determine which policies should be made permanent, Hahn has directed FDA staff to “identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but how to permanently make FDA more efficient in carrying out regulatory responsibilities.”
In the video, Hahn also highlighted the real-world evidence being used by the FDA to monitor the use of medical products during the pandemic. “We very much used real-world evidence and our Sentinel system and other resources to look back at the real-world use of diagnostic tests and medical products and then adjust our authorizations based on that,” he also noted that real-world evidence can help “to better understand disease, describe and measure immunity [and] understand the operating characteristics of tests.”
In the video, Hahn also references a pledge he made to himself and emphasized to his colleagues at the FDA to always base decisions on science and to renew their commitment to good data and sound science.