Senator Braun Introduces Bill to Accelerate FDA Approval for COVID Therapeutics

WASHINGTON - Senator Mike Braun, on Thursday, introduced the ADAPT for COVID (Accelerated Drug Approval for Prescription Therapies for Coronavirus) Act to accelerate drug approval for treatments for COVID-19.

Several countries have launched efforts to develop vaccines and treatments for COVID-19, but any treatment developed in another developed country will still need to go through FDA's burdensome approval process. That means that even when new treatments for COVID-19 developed abroad are safe, clinically effective, and can be manufactured safely and consistently, it will still be up to a full year before Americans can access them. 

This bill authorizes the FDA to create an expedited approval process to approve an application of a drug that is intended to treat or prevent the coronavirus or another disease of epidemic potential that is currently authorized to be marketed in other developed countries (such as Israel, Australia, Canada, South Korea, and Japan). This legislation requires FDA to review and make a determination on an approval application within 6 months of receiving the application. 

Senator Braun has called for increased investment in and rapid approval of COVID therapeutics since May of 2020.

"Operation Warp Speed was a incredible success, and considering that this virus will not be eradicated, we need to apply the same accelerated approval mindset to treatments and therapeutics for COVID-19 as we did for the vaccines." - Senator Mike Braun