EXPERRT Act of 2012
Latest action · Mar 9, 2012 Referred to the Subcommittee on Health.
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 7, 2012
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.
Requires, under such program, each review division within the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include: (1) rare diseases; (2) the severity of rare diseases; (3) the unmet medical need associated with rare diseases; (4) the willingness and ability of individuals with a rare disease to participate in clinical trials; (5) an assessment of the benefits and risks, including side effects, of current and investigational therapies; (6) the design of clinical trials for rare disease populations and subpopulations; and (7) demographics and the clinical description of patient populations. Allows external experts to request the opportunity to meet with a review division regarding any such topic. Authorizes the Secretary to determine the timing of each consultation, which may occur prior to, or following, the filing of an investigational new drug application, a new drug application, or a biologies license application.
Requires the experts consulted to be considered special government employees.
Cosponsors 22
Members who signed on, in the order they did. Signatures ran from Mar 7, 2012 to Nov 29, 2012; 2 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-FL | Cliff Stearns | Original | Mar 7, 2012 |
| R-PA | Tom Marino | Original | Mar 7, 2012 |
| D-NJ | Bill Pascrell, Jr. | Mar 28, 2012 | |
| R-PA | Charles W. Dent | Mar 28, 2012 | |
| D-AZ | Ed Pastor | Mar 28, 2012 | |
| R-LA | John Fleming | Mar 28, 2012 | |
| R-AL | Spencer Bachus | Mar 28, 2012 | |
| R-NC | Sue Wilkins Myrick | Mar 28, 2012 | |
| R-PA | Tim Murphy | Mar 28, 2012 | |
| R-LA | Bill Cassidy | May 8, 2012 | |
| D-CA | Bob Filner | May 8, 2012 | |
| R-NC | Howard Coble | May 8, 2012 | |
| D-MA | James P. McGovern | May 8, 2012 | |
| D-PA | Michael F. Doyle | May 8, 2012 | |
| R-SC | Mick Mulvaney | May 8, 2012 | |
| D-NY | Paul Tonko | May 8, 2012 | |
| R-NY | Peter T. King | May 8, 2012 | |
| D-VT | Peter Welch | May 8, 2012 | |
| R-VA | Frank R. Wolf | May 10, 2012 | |
| R-OR | Greg Walden | Jun 21, 2012 | |
| D-CA | Zoe Lofgren | Jun 21, 2012 | |
| D-FL | Kathy Castor | Nov 29, 2012 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 7, 2012 |
| Health Subcommittee | Referred Mar 9, 2012 |
Actions 3
Everything that happened, newest first.
- Mar 9, 2012Referred to the Subcommittee on Health.
- Mar 7, 2012Introduced in House
- Mar 7, 2012Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the page H1273.
Printed hearings 2
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| — | AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2013105 pages | Appropriations Committee | Mar 30, 2012 |
| S. Hrg. 112-853 | AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2013273 pages | Appropriations Committee | Mar 29, 2012–Apr 19, 2012 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 2281 | ExPERT Act | Related bill | Mar 29, 2012 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases.
- Short Titles as Introduced
- EXPERRT Act of 2012
- Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 7, 2012Introduced in House
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.
