Food and Drug Administration Safety Act of 2007
Latest action · Jan 31, 2007 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1455-1457)
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.
- IntroducedJan 31, 2007
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics 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 patient 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 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 Surveillance and Epidemiology.
Cosponsors 4
Members who signed on, in the order they did. Signatures ran from Jan 31, 2007 to Jun 14, 2007, with 3 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MD | Barbara A. Mikulski | Original | Jan 31, 2007 |
| D-CT | Christopher J. Dodd | Original | Jan 31, 2007 |
| D-NM | Jeff Bingaman | Original | Jan 31, 2007 |
| D-SD | Tim Johnson | Jun 14, 2007 |
Actions 3
Everything that happened, newest first.
- Jan 31, 2007Introduced in Senate
- Jan 31, 2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1455-1457)
- Jan 31, 2007Sponsor introductory remarks on measure. (CR S1454-1455)
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 788 | Food and Drug Administration Safety Act of 2007 | Identical bill | Feb 2, 2007 |
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.
- Jan 31, 2007Introduced 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.