Enhancing Drug Safety and Innovation Act of 2007
Latest action · Mar 14, 2007 Committee on Health, Education, Labor, and Pensions. Hearings held.
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.
- IntroducedFeb 1, 2007
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug.
Establishes a Drug Safety Oversight Board.
Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs.
Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases.
Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.
Cosponsors 1
Members who signed on, in the order they did. All signed on Feb 1, 2007.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MA | Edward M. Kennedy | Original | Feb 1, 2007 |
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 Feb 1, 2007Hearings Mar 14, 2007 |
Actions 4
Everything that happened, newest first.
- Mar 14, 2007Committee on Health, Education, Labor, and Pensions. Hearings held.
- Feb 1, 2007Introduced in Senate
- Feb 1, 2007Sponsor introductory remarks on measure. (CR S1530-1532)
- Feb 1, 2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In the Congressional Record 1
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 S1530–S1532 | Edward M. Kennedy D-MA, Michael B. Enzi R-WY | Feb 1, 2007 |
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.
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 |
|---|---|---|---|
| S. Hrg. 110-543 | ENSURING SAFE MEDICINES AND MEDICAL DEVICES FOR CHILDREN64 pages | Health, Education, Labor, and Pensions Committee | Mar 27, 2007 |
| S. Hrg. 110-384 | S. Hrg. 110-384 DRUG USER FEES: ENHANCING PATIENT ACCESS AND DRUG SAFETY89 pages | Health, Education, Labor, and Pensions Committee | Mar 14, 2007 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 1561 | Enhancing Drug Safety and Innovation Act of 2007 | Related bill | Mar 20, 2007 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes.
- Short Titles as Introduced
- Enhancing Drug Safety and Innovation Act of 2007
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Biomedical engineering
- Clinical trials
- Commerce
- Conflict of interests
- Congress
- Congressional reporting requirements
- Corporations
- Data banks
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Drug interactions
- Drug utilization
- Drugs
- Executive reorganization
- Federal advisory bodies
- Finance and Financial Sector
- Financial disclosure
- Food and Drug Administration (FDA)
- Generic drugs
- Government Operations and Politics
- Government paperwork
- Government publicity
- Health
- Health information systems
- Labeling
- Medical supplies
- Medical technology
- Nonprofit organizations
- Pharmaceutical research
- Product development
- Product safety
- Research centers
- Risk
- Science, Technology, Communications
- Social Welfare
- Technological innovations
Text 1
Each version as it was printed, newest first.
- Feb 1, 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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
