Posted on October 28, 2014
WASHINGTON, D.C., Oct. 28 —Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member Lamar Alexander (R-TN) announced their intention to introduce a bill to speed the development of treatments and vaccines for Ebola by adding Ebola to FDA’s priority review “voucher” program, a program at the Food and Drug Administration (FDA) designed to incentivize the development of new drugs for neglected tropical diseases. Currently Ebola is not listed as a qualifying tropical disease. The Harkin-Alexander bill, which will be introduced when Congress reconvenes, will seek to add Ebola as a qualifying disease under the program.
“In Iowa and around the country, families are counting on their leaders to ensure the U.S. is taking every step possible to contain Ebola and keep Americans healthy and safe. To help accomplish this, I plan to introduce a bill that will help FDA incentivize the development of new Ebola treatments,” Harkin said. “When enacted, as I hope it will be, this legislation will strengthen our response to Ebola and help innovators to continue their work to develop Ebola treatments and vaccines. I urge my colleagues to join me in passing this bill and continuing to invest in the public health agencies on the frontlines of the U.S. response to Ebola.”
“The world is in desperate need of a vaccine to prevent Ebola and a drug to treat it,” Alexander said. “This bill will help fight Ebola with a tool that encourages the development of necessary but unprofitable drugs—offering a reward for drug makers who invest the time and resources to develop drugs to treat, and hopefully cure, Ebola.”
The bill 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, Ebola is not considered a qualifying disease under current law, so 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 should be taken given that we need our full arsenal of tools at work.
On September 16, Senator Harkin convened a joint hearing entitled “Ebola in West Africa: A Global Challenge and Public Health Threat,” as chair of both the HELP Committee and the Labor-HHS Appropriations Subcommittee. This joint hearing was the first hearing in the U.S. Senate regarding Ebola.
Alexander has hosted two Ebola fact-finding roundtables in Memphis and Nashville and will hold a third event Friday in Chattanooga to learn more about the threat of the epidemic and Tennessee preparedness.