The Alliance for Health Policy https://allhealthpolicy.org held a press briefing with Dr. Stephen M. Hahn Commissioner of the FDA, https://www.fda.gov on January 8, 2021. The briefing was moderated by Dr. Reed Tuckson, Founder and Managing Director, Tuckson Health Connections https://www.tucksonhealthconnections.com.
Dr. Hahn started the conversation by saying, “The FDA as a science-based agency, states that their highest priority is to ensure the quality, safety, and effectiveness of vaccines. The agency is committed to making decisions guided by science and data regarding the authorization or approval of COVID-19 vaccines.”
An important issue under discussion concerns the Clinical Trials used to test COVID-19 vaccines. When considering clinical trial participants, it is very important to achieve diversity. That is why FDA strongly encourages enrollment in Clinical Trials to include racial and ethnic minorities, older adults, pregnant women and women of childbearing age, and as appropriate children.
He explained, “The one important tool used during the pandemic is the EUA. Since the start of the emergency, FDA has been able to use the EUA to provide a speedy response to the nation’s unprecedented demand for diagnostic tests, PPE, and other medical products.
Overall, during the pandemic, FDA has authorized more than 300 EUAs covering more than 600 products. That is more than ten times the amount of EUAs issued for all previous public health emergencies combined.
As Dr. Kahn reports, “The availability of digital health data and the use of real world data is very important as it can help accelerate the understanding of how COVID-19 is affecting patients and has the potential to provide a wealth of rapid, actionable information. This can be used to help scientists better understand disease symptoms, describe and measure immunity, and anticipate potential shortages of medical products.”
As noted in the FDA guidance, the temporary policies issued for certain digital health products during the COVID-19 pandemic are limited to select devices with low risk profiles that can offer benefits to patients. Digital health devices are key during EUA drug tests.
Other topics discussed concern how FDA is working hard in an ongoing effort to prevent fraud in the marketplace regarding products that are needed related to COVID-19, plus FDA is working hard to restrain cigarette and e-cigarette use by children.
Mention was made of the launch of the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) to help support collaboration and to increase the coordination of scientific leadership, agency operations, communications, and programming for regulated products.
Go to https://allhealthpolicy.org/a-conversation-with-dr-stephen-m-hahn-of-the-u-s-food-and-drug-administration for the video on the press briefing with Dr. Hahn.