Array
(
[actionDate] => 2016-04-05
[displayText] => Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
[externalActionCode] => 14000
[description] => Introduced
[chamberOfAction] => Senate
)
Passed Senate
Array
(
[actionDate] => 2016-09-22
[displayText] => Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
[externalActionCode] => 17000
[description] => Passed Senate
[chamberOfAction] => Senate
)
Passed House
Array
(
[actionDate] => 2016-09-27
[displayText] => Passed/agreed to in House: On passage Passed without objection.(text: CR H5945-5946)
[externalActionCode] => 8000
[description] => Passed House
[chamberOfAction] => House
)
To President
Array
(
[actionDate] => 2016-09-29
[displayText] => Presented to President.
[externalActionCode] => 28000
[description] => To President
[chamberOfAction] =>
)
Became Law
Array
(
[actionDate] => 2016-09-30
[displayText] => Became Public Law No: 114-229.
[externalActionCode] => 36000
[description] => Became Law
[chamberOfAction] =>
)
Passed/agreed to in House: On passage Passed without objection.(text: CR H5945-5946)
09/27/2016
Committee on Energy and Commerce discharged.
09/22/2016
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
04/05/2016
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
07/28/2015
Introduced in Senate
09/30/2016 Became Public Law No: 114-229.
09/30/2016 Signed by President.
09/29/2016 Presented to President.
09/27/2016 Passed/agreed to in House: On passage Passed without objection.(text: CR H5945-5946)
09/27/2016 Committee on Energy and Commerce discharged.
09/22/2016 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
04/05/2016 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
S.Amdt.5090 Amendment SA 5090 proposed by Senator Coats for Senator Sanders. (consideration: CR S6063: text: CR S6063) To improve the bill.
09/22/2016
Senate
Measure laid before Senate by unanimous consent. (consideration: CR S6062-6064)
04/05/2016
Senate
Placed on Senate Legislative Calendar under General Orders. Calendar No. 415.
04/05/2016
Senate
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
03/09/2016
Senate
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
07/28/2015
Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
09/30/2016 Became Public Law No: 114-229.
09/30/2016 Signed by President.
09/29/2016 Presented to President.
09/27/2016 Motion to reconsider laid on the table Agreed to without objection.
09/27/2016 On passage Passed without objection. (text: CR H5945-5946)
09/27/2016 Considered by unanimous consent. (consideration: CR H5945-5946)
09/27/2016 Committee on Energy and Commerce discharged.
09/27/2016 Mr. Walden asked unanimous consent to discharge from committee and consider.
09/22/2016 Referred to the House Committee on Energy and Commerce.
09/22/2016 Message on Senate action sent to the House.
09/22/2016 Received in the House.
09/22/2016 Passed Senate with an amendment by Unanimous Consent.
09/22/2016 The committee substitute as amended agreed to by Unanimous Consent.
09/22/2016 S.Amdt.5090 Amendment SA 5090 agreed to in Senate by Unanimous Consent.
09/22/2016 S.Amdt.5090 Amendment SA 5090 proposed by Senator Coats for Senator Sanders. (consideration: CR S6063: text: CR S6063) To improve the bill.
09/22/2016 Measure laid before Senate by unanimous consent. (consideration: CR S6062-6064)
04/05/2016 Placed on Senate Legislative Calendar under General Orders. Calendar No. 415.
04/05/2016 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
03/09/2016 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
07/28/2015 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.
(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.
(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.
Shown Here: Passed House without amendment (09/27/2016)
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.
Shown Here: Introduced in Senate (07/28/2015)
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.
