Harkin Applauds Passage of Bipartisan Bills Aimed at Speeding Development of Ebola Treatments and Improving Infant Health
Bipartisan Health Legislation Will Be 22nd and 23rd HELP Committee Bills Signed Into Law Under Harkin’s Leadership as Chairman
Thursday, December 04, 2014
WASHINGTON, D.C.—Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded Congressional passage of two bipartisan health bills: the Adding Ebola to the FDA Priority Review Voucher Program Act and the Sudden Unexpected Death Data Enhancement and Awareness Act.
Led by Harkin as chairman, both bipartisan bills were passed by the HELP Committee in November and cleared the Senate in recent weeks. With House passage this week, both bills now head to the President’s desk for his signature and are set to become the 22nd and 23rd HELP Committee bills to be signed into law this Congress under Harkin’s leadership as chairman.
“Today I am pleased to see the continued success of the HELP Committee’s bipartisan work as we send these critical bills to the President’s desk. Strengthening investments in public health has been one of my top priorities and these bills will continue that work,” Harkin said. “The Adding Ebola to the FDA Priority Review Voucher Program Act will incentivize the development of much-needed Ebola treatments and vaccines. The Sudden Unexpected Death Data Enhancement and Awareness Act will strengthen lifesaving outreach efforts, enhance surveillance and data collection, and help us to better understand and eventually prevent these tragic deaths. The passage of these important bills is a testament to the true bipartisan spirit of the HELP Committee. I thank my colleagues on both sides of the aisle and in both chambers and urge the President to sign them as soon as possible.”
The Adding Ebola to the FDA Priority Review Voucher Program Act would add Ebola to the Food and Drug Administration’s (FDA) 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 vaccine or 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.
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 Sudden Unexpected Death Data Enhancement and Awareness Act will continue activities related to data collection on stillbirth, sudden unexpected infant death (SUID), and sudden unexplained death in childhood (SUDC). The bill also promotes the dissemination of information on stillbirth, sudden unexpected infant death, and sudden unexplained death in childhood to the public and stakeholders as well as fostering collaboration with the Attorney General and others to provide consistent information for medical examiners and coroners, law enforcement personnel, and health care providers related to death scene investigations and autopsies.
Additionally, the bill calls on the Secretary of Health and Human Services (HHS) to submit a report to Congress on HHS activities on stillbirth, SUID, and SUDC.
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