Creating Hope Act of 2011
Latest action · Mar 17, 2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 17, 2011
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Creating Hope Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for tropical diseases to: (1) include rare pediatric diseases; (2) allow unlimited transfers of vouchers under the program; and (3) require a sponsor intending to use a voucher to notify the Secretary of Health and Human Services (HHS) at least 90 days (currently, 365 days) before submission of the application.
Revises provisions regarding the priority review user fee, including to make it payable upon notification of the Secretary of intent to use the voucher.
Authorizes the Secretary, upon request of the manufacturer or sponsor of a new drug, to designate that a new drug is: (1) for a rare pediatric disease, and (2) an innovative treatment.
Requires the Secretary to deem a rare pediatric disease product application to be incomplete if it does not contain a description of the sponsor's plan to market the product in the United States. Authorizes the Secretary to refuse to issue a priority review voucher upon the approval of a rare pediatric disease application if the Secretary finds that the sponsor lacks a good faith intention to market the product in the United States. Directs the Secretary to issue a guidance document setting forth the evidentiary support necessary to demonstrate such a good faith intention.
Requires sponsors of applications under the priority review voucher program to report to the Secretary within five years after the approval of the application on the demand and distribution of the product within the United States.
Cosponsors 11
Members who signed on, in the order they did. Signatures ran from Mar 17, 2011 to Jun 5, 2012; 4 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MN | Al Franken | Original | Mar 17, 2011 |
| R-GA | Johnny Isakson | Original | Mar 17, 2011 |
| R-MA | Scott P. Brown | Original | Mar 17, 2011 |
| D-OH | Sherrod Brown | Original | Mar 17, 2011 |
| D-NY | Kirsten E. Gillibrand | May 17, 2011 | |
| D-CT | Richard Blumenthal | Jun 23, 2011 | |
| R-MO | Roy Blunt | Sep 26, 2011 | |
| R-ID | Mike Crapo | Oct 3, 2011 | |
| R-LA | David Vitter | Dec 1, 2011 | |
| D-NY | Charles E. Schumer | Mar 28, 2012 | |
| D-NJ | Frank R. Lautenberg | Jun 5, 2012 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Mar 17, 2011 |
Actions 2
Everything that happened, newest first.
- Mar 17, 2011Introduced in Senate
- Mar 17, 2011Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 3059 | Creating Hope Act of 2011 | Related bill | Sep 26, 2011 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the priority review voucher incentive program relating to tropical and rare pediatric diseases.
- Short Titles as Introduced
- Creating Hope Act of 2011
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 17, 2011Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
