U.S. Representatives G. K. Butterfield (NC-01) and Susan Brooks (IN-05) have introduced H.R. 4400, a bipartisan bill that seeks to add the Zika virus to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the FDA. The Zika virus, which is transmitted to humans by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. The World Health Organization has labeled Zika a global public health emergency.
“Zika virus is an emerging public health crisis that demands an immediate and urgent response,” said Butterfield. “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.”
“We must act to ensure that the U.S. is protected from an outbreak,” Brooks said. “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.”
In May 2015, Brazil reported its first case of Zika virus. Since then, the disease has spread within Brazil and to 28 other countries and territories in the region. The spread of the Zika virus is widely thought to be linked to the steep increase of babies born with abnormally small heads and underdeveloped brains known as microcephaly. The pandemic is so concerning that some governments are urging women to delay pregnancy altogether until a treatment or vaccine is created.
“Zika is impacting people across the world and must be eliminated using a comprehensive strategy that includes the development of a treatment options,” said Butterfield. “Researchers in my state of North Carolina and across the country have the talent, experience, and expertise to develop a treatment or cure. The right incentives made available through the Priority Review Voucher program encourage private sector development of innovative treatments and cures.”
“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,” Brooks continued. “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.”
The Priority Review Voucher Program was authorized by Congress in 2007 to incentivize the development of treatments, including vaccines and cures, for neglected tropical diseases. Under the program, a company that receives approval for a tropical disease treatment is eligible to receive a voucher that allows the bearer to receive priority review status for any future product. Products undergoing priority review are generally provided with an approval decision within six months.