Senator Braun introduces bill to accelerate FDA approval for COVID therapeutics

WASHINGTON – Senator Mike Braun today 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,” said Senator Mike Braun.

Senator Mike Braun

BACKGROUND 

Throughout the COVID-19 pandemic, several countries launched efforts to develop vaccines and treatments for COVID-19. However, treatments and vaccines approved in these developed countries, which have regulatory systems similar to the U.S., will not be available to Americans unless the drug is approved by the FDA. Unfortunately, the burdensome FDA regulatory process threatens to delay vaccines or treatments from being accessible to Americans for up to a full year even after a successful vaccine or treatment has been developed.

This legislation would authorize 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. Additionally, the drug sponsor would have to demonstrate that the drug is safe and clinically effective, the manufacturer is capable of manufacturing the drug safely and consistently outside of the United States, and that the drug is intended for the treatment or prevention of the coronavirus or another disease of epidemic potential. Under this legislation, the FDA may request the drug sponsor conduct post-approval studies to verify the predicted effect or clinical benefit of the drug, or for copies of all promotional materials related to the product during the pre-approval review period and following approval, at least 30 days prior to dissemination of the materials.

This legislation retains all of FDA’s safety and efficacy standards but creates an expedited approval pathway for treatments approved in other countries focused on quality control, supply chain safety, and manufacturing process. Additionally, this would also address the list of drug shortages facing this country. This legislation would ensure that if other countries develop important vaccines or treatments before the U.S., those treatments will be quickly approved by the FDA and available to Americans.

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