Ebola Treatments Bill Passes in Both Houses Unanimously

Bill strengthens FDA tropical disease priority review voucher program to incentivize new cures

Charles J. Arntzen, PhD Arizona Bioscience Researcher of the Year

Charles J. Arntzen, PhD, Arizona Bioscience Researcher of the Year, was a key contributor in research that lead to the development of ZMapp, the ebola drug, developed by Mapp Biopharmaceutical Inc. The experimental treatment that may have saved the lives of two Americans infected with the ebola virus grew from the pioneering efforts of researchers at Arizona State University’s Biodesign Institute, led by Charles Arntzen. An ASU Regents’ Professor, Arntzen has spent more than two decades working on ways to better deliver and produce vaccines for human consumption.

 

The Adding Ebola to the FDA Priority Review Voucher Program Act has passed both Houses of Congress and is on its way to President Obama. The Act would add Ebola to the Food and Drug Administration’s (FDA) tropical disease priority review voucher program, under which developers of a vaccine or treatment for a qualifying tropical disease receive a voucher for FDA priority review for another product of its choice.

The Act would make several other important changes to the program, allowing the Secretary of Health and Human Services to more easily add to the list of diseases which qualify for the program. The Act would also allow the vouchers to be sold and transferred multiple times by manufacturers, increasing their value. In addition, the Act would shorten the timeline for notifying FDA of the intention to submit a priority review voucher, providing companies with greater flexibility. These changes would help harmonize the tropical disease priority review voucher program with the rare pediatric disease priority review voucher program.

“Every day, countless men and woman at biotechnology companies across the globe are hard at work to develop preventative vaccines and therapeutic treatments which could help curb the Ebola crisis and prevent future outbreaks,” shared BIO President and CEO Jim Greenwood.  “The Adding Ebola to the FDA Priority Review Voucher Program Act would further encourage these efforts, not only for Ebola, but also for other devastating diseases. The Act strengthens the tropical disease priority review voucher program in several important respects, increasing the value of the vouchers and spurring the development of products to treat or prevent qualifying diseases.”

 

Posted in AZBio News.