Food and Drug Administration Safety Act of 2005
Latest action · Apr 27, 2005 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.
- IntroducedApr 27, 2005
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Food and Drug Administration Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Drug Evaluation and Research within the Food and Drug Administration (FDA).
Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international surveillance databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the general public; (5) taking corrective action if such an unreasonable risk may exist; and (6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner.
Requires the Drug Safety and Risk Management Drug Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions.
Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act.
Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances.
Transfers to the Center the functions and duties of the Office of Drug Safety.
Cosponsors 7
Members who signed on, in the order they did. Signatures ran from Apr 27, 2005 to Sep 20, 2006; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CT | Christopher J. Dodd | Original | Apr 27, 2005 |
| R-MS | Thad Cochran | Apr 28, 2005 | |
| R-RI | Lincoln Chafee | May 25, 2005 | |
| D-NM | Jeff Bingaman | Jul 19, 2005 | |
| D-MD | Barbara A. Mikulski | May 4, 2006 | |
| D-WV | John D. Rockefeller IV | Jun 16, 2006 | |
| D-SD | Tim Johnson | Sep 20, 2006 |
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 Apr 27, 2005 |
Actions 3
Everything that happened, newest first.
- Apr 27, 2005Introduced in Senate
- Apr 27, 2005Sponsor introductory remarks on measure. (CR S4426-4427)
- Apr 27, 2005Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In the Congressional Record 2
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S13095 | Chuck Grassley R-IA | Nov 17, 2005 |
| Senate | Debate and remarks S4426, S4427 | Christopher J. Dodd D-CT, Chuck Grassley R-IA | Apr 27, 2005 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 4429 | Food and Drug Administration Safety Act of 2005 | Identical bill | Dec 2, 2005 |
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 with respect to drug safety, and for other purposes.
- Short Titles as Introduced
- Food and Drug Administration Safety Act of 2005
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative remedies
- Advertising
- Biomedical engineering
- Clinical trials
- Commerce
- Congress
- Congressional reporting requirements
- Consumer education
- Cost effectiveness
- Data banks
- Department of Health and Human Services
- Drug adulteration
- Drug approvals
- Drug industry
- Epidemiology
- Executive reorganization
- Federal advisory bodies
- Finance and Financial Sector
- Fines (Penalties)
- Food and Drug Administration (FDA)
- Government Operations and Politics
- Government paperwork
- Government publicity
- Health
- Health information systems
- Law
- Licenses
- Medical supplies
- Pharmaceutical research
- Product safety
- Risk
- Sales promotion
- Science, Technology, Communications
Text 1
Each version as it was printed, newest first.
- Apr 27, 2005Introduced 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.