Adding Ebola to the FDA Priority Review Voucher Program Act

Bill: 113-s-2917
Sponsor: Sen. Harkin, Tom [D-IA]
Introduced: 2014-11-12 in the Senate
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation
Drug therapy
Infectious and parasitic diseases

Summary:
action_date: 2014-11-12
text: 
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.
action_date: 2014-11-19
text: 

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

 
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.
action_date: 2014-12-02
text: 

(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.
action_date: 2014-12-03
text: 

(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.
action_date: 2014-12-16
text: 

(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.

Legislative actions:
action_date: 2014-12-16
text: Became Public Law No: 113-233.
action_date: 2014-12-16
text: Became Public Law No: 113-233.
action_date: 2014-12-16
text: Signed by President.
action_date: 2014-12-16
text: Signed by President.
action_date: 2014-12-10
text: Presented to President.
action_date: 2014-12-10
text: Presented to President.
action_date: 2014-12-03
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2014-12-03
text: On passage Passed without objection. (text: CR H8344)
action_date: 2014-12-03
text: Passed/agreed to in House: On passage Passed without objection.(text: CR H8344)
action_date: 2014-12-03
text: Considered by unanimous consent. (consideration: CR H8344)
action_date: 2014-12-03
text: Mr. Bilirakis asked unanimous consent to take from the Speaker's table and consider.
action_date: 2014-12-03
text: Held at the desk.
action_date: 2014-12-03
text: Message on Senate action sent to the House.
action_date: 2014-12-03
text: Received in the House.
action_date: 2014-12-02
text: Passed Senate without amendment by Unanimous Consent. (consideration: CR S6271; text as passed Senate: CR S6271)
action_date: 2014-12-02
text: Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S6271; text as passed Senate: CR S6271)
action_date: 2014-11-19
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 602.
action_date: 2014-11-19
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin without amendment. Without written report.
action_date: 2014-11-19
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin without amendment. Without written report.
action_date: 2014-11-19
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
action_date: 2014-11-12
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2014-11-12
text: Introduced in Senate

Enacted as: number: 113-233