Adding Ebola to the FDA Priority Review Voucher Program Act became law 34 days after introduction, with cosponsors split almost evenly between the parties
Written by the Congressional Research Service [2]. 188 words.
(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.) Adding Ebola to the FDA Priority Review Voucher Program Act -
(Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.) Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS). Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times. Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.
- Committees
- Senate Health, Education, Labor, and Pensions Committee
- Policy area
- Health: 122 of 9,357 bills became law, 113th–118th (1.3%)
- Sponsor
- 3 of 52 bills enacted since 2013
- Text versions
- 5, from enrolled bill to public law · 330 words
- Subjects
- Drug safety, medical device, and laboratory regulationDrug therapyInfectious and parasitic diseases
- Latest action
- Dec 16, 2014: Became Public Law No: 113-233.
- Records
- Congress.gov · Bill text
Each bill appears once, under its strongest link. 1 in all.
Identical or companion · 1
- 113th H.R. 5729 Adding Ebola to the FDA Priority Review Voucher Program Act R · Introduced