Reps. Blackburn, Green, Butterfield, McCaul & Fleischmann Introduce Legislation as Part of Effort to Combat Ebola Virus
Representatives Marsha Blackburn (TN-07), Gene Green (TX-29), G. K. Butterfield (NC-01), Michael McCaul (TX-10), and Chuck Fleischmann (TN-03) have introduced H.R.5729, which would add filoviruses to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the Food and Drug Administration (FDA). The filovirus family includes all known strains of Ebola as well as the related Marburg virus.
“With nearly 15,000 cases and over 5,000 deaths, the 2014 Ebola epidemic is the worst since the discovery of the virus in 1976,” Blackburn said. “In light of this global outbreak there should be an intensive effort to find and approve a treatment or better yet, a vaccine to prevent Ebola. I want to thank my colleagues – Reps. Green, Butterfield, McCaul, and Fleischmann – for joining me in this important effort with the introduction of H.R. 5729. Decreasing the time it takes for a company to bring a drug safely through the FDA to approval provides a great incentive for the development of other drugs, particularly those that have historically been neglected.”
Rep. Gene Green: “In 2007, Congress took action to break down economic barriers for developing treatments and vaccines effective against tropical diseases by establishing the tropical disease priority review voucher program. Now it’s time for Congress to act again, and respond to the Ebola outbreak by making therapies and vaccines to treat the deadly virus eligible for the program. The Ebola outbreak is the worst in history, and this crisis demands swift actions to combat the epidemic. This legislation will help fight Ebola by rewarding investments and efforts to find effective vaccines and cures.”
Rep. Butterfield: “I am pleased to join my colleagues in introducing this important legislation.I was excited to learn that two North Carolina companies have been pursuing Ebola vaccines – one to treat the virus and another to prevent it entirely. I am hopeful that this bill – if passed – will encourage quick action so that lives can be spared and the disease stopped for good.”
Rep. McCaul: “Ebola has garnered the attention of the world and must be combated with a comprehensive strategy including the development of a cure. U.S. companies have the unique talents and ingenuity to develop a vaccine but they need the right incentives to justify the extraordinary up front investment necessary to bring a drug to market. I am proud to support Rep. Blackburn's bill which builds on the innovate priority review voucher program for tropical diseases and ensures that Ebola is not neglected.”
Rep. Fleischmann: “Ensuring the timely development and availability of lifesaving treatments and vaccines is vital to thwarting the spread of deadly diseases. In order to protect our nation from the current Ebola outbreak and future threats, we must cut out the red tape that is prohibiting the prompt approval of these critical treatments and create incentives for developers of new drugs and therapies.”
The Priority Review Voucher Program was authorized by Congress in 2007 to incentivize the development for neglected tropical diseases. Under this 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 given an approval decision within six months instead of the usual ten months.