Advancing Hope Act of 2016

Bill: 114-s-1878
Sponsor: Sen. Casey, Robert P., Jr. [D-PA]
Introduced: 2015-07-28 in the Senate
Policy area: Health
Subjects: Blood and blood diseases
Cancer
Child health
Drug safety, medical device, and laboratory regulation
Drug therapy
Hereditary and development disorders
Infectious and parasitic diseases
World health

Summary:
action_date: 2015-07-28
text: 

Advancing Hope Act of 2015

 
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. 
 
The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration's (FDA's) issuance of three rare pediatric disease vouchers.
 
A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product.
 
A drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of that intent upon submission of the new drug application.

action_date: 2016-09-27
text: 

Advancing Hope Act of 2016

 
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for rare pediatric disease medications. (A priority review voucher is a transferable voucher that entitles the holder to have a new drug or biological product application acted upon by the Food and Drug Administration (FDA) within six months.) The program is restricted to treatments for serious diseases and is terminated at the end of 2016.
 
Beginning 90 days after enactment of the bill, a medication sponsor who intends to request a voucher for a rare pediatric disease medication must notify the FDA of that intent upon submission of the application for the medication.
 
 The bill applies to applications submitted to the FDA before enactment of the bill that have not been approved. Applications submitted before October 7, 2012, are not eligible for a voucher.
 
A voucher may not be issued for a rare pediatric disease product if a voucher was already issued for the medication under another program.
 (Sec. 3) The Government Accountability Office must study the effectiveness of awarding priority review vouchers as an incentive for the development of medications for rare pediatric diseases that would not otherwise have been developed.
action_date: 2016-09-30
text: 
(This measure has not been amended since it was passed by the Senate on September 22, 2016. The summary of that version is repeated here.)
 

Advancing Hope Act of 2016

 
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for rare pediatric disease medications. (A priority review voucher is a transferable voucher that entitles the holder to have a new drug or biological product application acted upon by the Food and Drug Administration (FDA) within six months.) The program is restricted to treatments for serious diseases and is terminated at the end of 2016.
 
Beginning 90 days after enactment of the bill, a medication sponsor who intends to request a voucher for a rare pediatric disease medication must notify the FDA of that intent upon submission of the application for the medication.
 
 The bill applies to applications submitted to the FDA before enactment of the bill that have not been approved. Applications submitted before October 7, 2012, are not eligible for a voucher.
 
A voucher may not be issued for a rare pediatric disease product if a voucher was already issued for the medication under another program.
 (Sec. 3) The Government Accountability Office must study the effectiveness of awarding priority review vouchers as an incentive for the development of medications for rare pediatric diseases that would not otherwise have been developed.

Legislative actions:
action_date: 2016-09-30
text: Became Public Law No: 114-229.
action_date: 2016-09-30
text: Became Public Law No: 114-229.
action_date: 2016-09-30
text: Signed by President.
action_date: 2016-09-30
text: Signed by President.
action_date: 2016-09-29
text: Presented to President.
action_date: 2016-09-29
text: Presented to President.
action_date: 2016-09-27
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2016-09-27
text: On passage Passed without objection. (text: CR H5945-5946)
action_date: 2016-09-27
text: Passed/agreed to in House: On passage Passed without objection.(text: CR H5945-5946)
action_date: 2016-09-27
text: Considered by unanimous consent. (consideration: CR H5945-5946)
action_date: 2016-09-27
text: Committee on Energy and Commerce discharged.
action_date: 2016-09-27
text: Committee on Energy and Commerce discharged.
action_date: 2016-09-27
text: Mr. Walden asked unanimous consent to discharge from committee and consider.
action_date: 2016-09-22
text: Referred to the House Committee on Energy and Commerce.
action_date: 2016-09-22
text: Message on Senate action sent to the House.
action_date: 2016-09-22
text: Received in the House.
action_date: 2016-09-22
text: Passed Senate with an amendment by Unanimous Consent.
action_date: 2016-09-22
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
action_date: 2016-09-22
text: The committee substitute as amended agreed to by Unanimous Consent.
action_date: 2016-09-22
text: Measure laid before Senate by unanimous consent. (consideration: CR S6062-6064)
action_date: 2016-04-05
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 415.
action_date: 2016-04-05
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-04-05
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-03-09
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2015-07-28
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2015-07-28
text: Introduced in Senate

Enacted as: number: 114-229