U.S. Reps. Susan W. Brooks (R-IN) and G. K. Butterfield (D-N.C.) introduced a bipartisan bill – H.R. 4400 – on Tuesday that would add the Zika virus to the Food and Drug Administration’s (FDA) Tropical Disease Priority Review Voucher Program.
“Just yesterday, the World Health Organization (WHO) declared the Zika virus outbreak in the Americas a global health emergency, and we must act to ensure that the United States is protected from an outbreak,” Brooks said on Tuesday. “Work is already underway to create a vaccine, but without a Priority Review Voucher in place, a vaccine may not be available for years. We do not have the luxury of time, and I strongly urge my colleagues to join this effort and encourage the rapid development of a vaccine or treatment for this disease.
“As a country, we are unprepared to meet the challenges of an epidemic, and part of the solution is incentivizing researchers and manufacturers to develop and test vaccines and treatments before an epidemic or outbreak occurs. In this case, we need to do everything we can to make sure that we eliminate any roadblocks to the development, testing and ultimate distribution of a vaccine or therapy for Zika virus.”
Zika virus is transmitted to humans by mosquitoes. Pregnant women infected with the virus face a higher rate of birth defects, including microcephaly and neurological disorders. In adults, the virus can lead to skin rashes, conjunctivitis, muscle and joint pain, and headaches.
Brazil reported its first case of Zika virus in May. The disease has since spread to 28 other countries and territories in the region and is believed to be linked to a sharp increase in the number of babies born with abnormally small heads and underdeveloped brains.
“Zika virus is an emerging public health crisis that demands an immediate and urgent response,” Butterfield said. “Zika has spread from Asia and Africa to the Caribbean, South and Central America, and now has appeared in Mexico and Puerto Rico. There should be an intensive effort to develop and approve a treatment for Zika or prevent it entirely.”
Authorized by Congress in 2007, the Priority Review Voucher Program incentivizes the development of treatments, including vaccines and cures, for neglected tropical diseases. Companies receiving approval for a tropical disease treatment as part of the program are eligible for a voucher allowing the bearer to receive priority review status for any future product. Priority review products generally receive an approval decision within six months.