Pandemic Actions Taken ... and Lessons Learned

On June 2, the Alliance for a Stronger FDA was pleased to host Dr. Stephen Hahn, Commissioner of the US Food and Drug Administration. About 120 members and more than 20 reporters heard Dr. Hahn talk about the FDA’s role in combating COVID-19 and related issues. A shorter, pre-recorded version of his remarks are on video here, including a transcript. Commissioner Hahn thanked the Alliance for supporting FDA and its critical public health mission.Dr. Hahn began by expressing his appreciation for the hard work and commitment of FDA staff in dealing with the current pandemic. He also thanked former FDA leaders, Alliance members, and his colleagues in the medical community.He pledged (and emphasized) his continuing commitment to decisions based on good data and sound science.Dr. Hahn reviewed a number of aspects of the FDA’s COVID-19 response:

• Food Safety. The agency has worked through Deputy Commissioner Yiannas’ office to ensure an adequate food supply during the crisis. In particular, they were effective in supporting adjustments in the food supply chain caused by the abrupt change to a market dominated by retail outlets. The agency is continually working to protect against outbreaks of foodborne disease. FDA has worked with CDC and USDA to provide guidance for food workers and consumers.
• Medical Products. The agency is working to develop diagnostic tests, vaccines, and therapeutics. FDA is working with companies that have converted their production lines to manufacture PPE and ventilators. The agency is continuing to ensure access to medical products and remove counterfeit medical devices from the market. To date, the agency has issued 100 Emergency Use Authorizations for medical devices and reviewed studies on  more than 90 drugs for their potential impact on COVID-19.
• Data-Sharing. FDA is working with NIH and CDC to gather coronavirus diagnostic testing data.
• Vaccine Development. “Operation Warp Speed” will be working with researchers and manufacturers to develop a vaccine by the end of this calendar year or early next year. When that produces candidates for review, FDA will not shirk its responsibility to assure vaccines are safe and effective. CDER Director Woodcock has temporarily stepped down from her role and is working with “Operation Warp Speed.” CBER Director Marks is continuing to lead FDA’s review of vaccines.
• Health Education. Dr. Hahn talked about the agency’s role and commitment to providing consumer education during the pandemic. He noted opportunities to help individuals shop safely, protect themselves fully, and understand when to call their physician and be tested. He also drew attention to the role telehealth is playing in ensuring safety during the pandemic.
• Policy and Regulation. Commissioner Hahn said

I have instructed my staff to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but to make FDA itself more efficient in carrying out our regulatory responsibilities.

He pointed to decentralized clinical trials as a direction the agency was working on that will be accelerated by the pandemic and continue afterward.

Commissioner Hahn closed by again praising FDA staff -- both for their commitment to addressing COVID-19 and for maintaining the agency’s other responsibilities. He encouraged participants to stay safe and healthy during the public health emergency.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA. Special thanks to Reed Diskey for sharing his meeting notes.