WASHINGTON, D.C. —Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member Lamar Alexander (R-TN), along with several other HELP Committee cosponsors introduced a bill to incentivize the development of treatments and vaccines for Ebola by adding the disease to the Food and Drug Administration’s (FDA) priority review voucher program, an initiative designed to help speed the development of new drugs for neglected tropical diseases. Currently Ebola is not listed as a qualifying tropical disease. The Harkin-Alexander bill introduced today would add Ebola as a qualifying disease under the FDA priority review voucher program.
“With the release this week of Dr. Craig Spencer, the doctor who contracted Ebola in West Africa before returning to New York City and who is now Ebola-free, Americans are seeing real progress in the U.S. response to this deadly virus. But we know we must do more in the weeks and months ahead to help keep Americans safe and deliver much-needed vaccines and treatments to those who need them,” Harkin said. “To help with our response, today I am introducing a bill that allows FDA to incentivize the development of new Ebola treatments and vaccines. Once signed into law, this bill will strengthen our response to Ebola and help innovators continue their work to develop these critical products. I urge my colleagues to join me in passing this bill as we work to continue our investment in the public health agencies on the frontlines of the U.S. response to Ebola and other infectious diseases.”
“Ebola is one of the most explosive, deadly epidemics in modern times—and it continues to kill men, women, and children in West Africa at alarming rates. 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 vaccines and drugs with little to no market in the United States —offering a reward to innovators who invest the time and resources to develop vaccines and 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, 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.
The co-sponsors of the bill include Senators Barbara Mikulski (D-MD), Mike Enzi (R-WY), Patty Murray (D-WA), Richard Burr (R-NC), Bob Casey (D-PA), Johnny Isakson (R-GA), Kay Hagan (D-NC), Orrin Hatch (R-UT), Al Franken (D-MN), Pat Roberts (R-KS), Michael Bennet (D-CO), Mark Kirk (R-IL), Sheldon Whitehouse (D-RI), Tim Scott (R-SC), Tammy Baldwin (D-WI), Chris Murphy (D-CT), and Elizabeth Warren (D-MA).
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 three Ebola fact-finding roundtables in Memphis, Nashville, and Chattanooga to learn more about the threat of the epidemic and Tennessee preparedness.