Adding Ebola to the FDA Priority Review Voucher Program Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Nov 18, 2014)
Adding Ebola to the FDA Priority Review Voucher Program Act - 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.What just happenedNov 21, 2014
Referred to the Subcommittee on Health.
Who’s behind it
- Introduced in HouseNov 18, 2014
- Nov 21, 2014Committee
Referred to the Subcommittee on Health.
- Nov 18, 2014IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
- Nov 18, 2014IntroReferralIntro-H
Introduced in House
- Nov 18, 2014IntroReferral1000
Introduced in House