WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) applauds the unanimous House passage late Wednesday of the Adding Ebola to the FDA Priority Review Voucher Program Act. 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.
The following statement may be attributed to BIO President and CEO Jim Greenwood:
“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. 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.
“I thank Energy and Commerce Committee Chairman Fred Upton and Vice Chairman Marsha Blackburn for their championship of this critical legislation. Their leadership will help to advance the development of new cures and treatments for Ebola as well as other deadly diseases.
“I urge President Obama to act swiftly to sign into law this important legislation, which has now passed both chambers of Congress with unanimous bipartisan support.”
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.
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