BPCA and PREA Reauthorization Act of 2012
Latest action · Mar 30, 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 28, 2012
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA).
Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity.
Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change.
Requires a product sponsor to submit an Initial Pediatric Plan as part of the drug application process and sets forth the process for such submission.
Authorizes the Secretary of Health and Human Services (HHS) to: (1) grant a deferral extension, and sets forth the conditions for such deferral; and (2) issue a non-compliance letter to a product sponsor failing to meet post-marketing requirements, and requires the product sponsor to respond in writing.
Authorizes the Pediatric Review Committee to review deferral extensions.
Requires the Office of Pediatric Therapeutics to include a neonatologist and pediatric epidemiologist.
Reauthorizes the Pediatric Advisory Committee and the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.
Cosponsors 2
Members who signed on, in the order they did. All signed on Mar 28, 2012.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Anna G. Eshoo | Original | Mar 28, 2012 |
| D-MA | Edward J. Markey | Original | Mar 28, 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 28, 2012 |
| Health Subcommittee | Referred Mar 30, 2012 |
Actions 3
Everything that happened, newest first.
- Mar 30, 2012Referred to the Subcommittee on Health.
- Mar 28, 2012Introduced in House
- Mar 28, 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 H1740.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 5651 | Food and Drug Administration Reform Act of 2012 | Related bill | Jun 4, 2012 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003.
- Short Titles as Introduced
- BPCA and PREA Reauthorization Act of 2012
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Advisory bodies
- Cancer
- Child health
- Congressional oversight
- Consumer affairs
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Food and Drug Administration (FDA)
- Government information and archives
- Health
- Intellectual property
- Medical research
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Mar 28, 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.
