This bill seeks to add Zika virus to a list of diseases included in the Tropical Disease Priority Review Voucher Program, operated by the Food and Drug Administration (FDA). This program offers incentives and speeds up the review process for medications that treat "neglected diseases" prevalent in the developing world.
Zika has affected more than one million people in Brazil and spread to at least 30 countries and territories. The virus is passed to humans by mosquitoes, although the Centers for Disease Control and Prevention (CDC) confirmed the first known sexually transmitted case in Dallas, TX on February 2, 2016. Florida has also confirmed 9 cases of Zika and consequently issued a state of emergency.
Zika can cause fever, rash, joint pain, and red eyes, although most infected people display no symptoms.
There are currently no vaccines or treatments to prevent or cure Zika. Rep. Butterfield’s bill would make it easier for the FDA to reward companies that develop vaccines or treatments for the virus, using the Priority Review Voucher Program, which was created by Congress as part of the 2007 FDA Amendments Act.
Under the voucher program, a company that develops an FDA-approved treatment for a neglected tropical disease is eligible to receive a special voucher that can be redeemed for a fast-tracked FDA review of another product in the future. The company may use the voucher itself, or sell it to another development company for up to hundreds of millions of dollars. Products undergoing this fast-tracked review are usually approved or denied within six months (as opposed to the standard review process, which averages more than a year).
The neglected disease voucher program currently lists 21 qualifying diseases like tuberculosis, malaria, cholera, dengue fever, and leprosy. Congress added Ebola to the qualifying list in December 2014. Vouchers may also be awarded for the development of a medication for any other infectious disease that primarily affects poor and marginalized populations.