WASHINGTON, D.C.— Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member Lamar Alexander (R-TN) today applauded HELP Committee approval of the Adding Ebola to the FDA Priority Review Voucher Program Act.
“As the U.S. continues to respond to Ebola, it is critical that we are doing all we can to get life-saving treatments to those impacted by the disease," Harkin said. "The bill approved today will help to accomplish that by allowing FDA to incentivize the development of new Ebola treatments and vaccines.
Alexander said: “The world desperately needs an approved therapy to treat Ebola and a vaccine to prevent it. With this bill, we hope to spur the development of these drugs, which will be game changers in our fight against the disease.”
The Adding Ebola to the FDA Priority Review Voucher Program Act would add Ebola to FDA’s priority review voucher program, which Congress first authorized in 2007 to promote the development of new treatments and vaccines for neglected tropical diseases. Under the program, a developer of a treatment for a qualifying tropical disease receives a voucher for FDA priority review to be used with a second product of its choice, or this voucher can be sold.
However, because Ebola is not considered a qualifying disease under current law, developers of Ebola treatments and vaccines currently do not qualify for the program. This bill would change that and immediately add Ebola to the program – a step that would add another tool to help fight Ebola. The bill also makes changes to improve the functioning of the program and allow FDA to respond more efficiently to infectious disease threats in the future.