FDA Leader Gives Agency Low Marks On COVID Data Assessment
FDA GIVES ITSELF FAILING MARKS FOR USING REAL-WORLD DATA TO BETTER UNDERSTAND THE CORONAVIRUS PANDEMIC
(CNN) – The Food and Drug Administration has given itself a failing grade on using data to better understand the coronavirus pandemic.
During an agency briefing, FDA Principal Deputy Commissioner Dr. Amy Abernethy gave her agency a “two out of ten” when it comes to understanding data for COVID-19.
The FDA is compelled to use real-world data to study new indications for existing drugs under the the 21st century cures act.
That was signed by president Donald Trump in 2016.
Abernethy says the FDA started looking at sources like patient records and billing claims to learn about the natural history of coronavirus in March.
The exercise showed the network of peer reviewers who can assess the data is limited.
The FDA ended up turning to the private sector in a partnership called “evidence accelerator,” which helped determine hydroxycholoroquine was not an effective COVID-19 treatment.
Abernethy gives her agency a nine of out ten for its vision to do better in the future.