Access to Life-Saving Medicine Act
Latest action · Feb 27, 2007 Star Print ordered on S. 623.
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 15, 2007
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product.
Sets forth conditions for approval of such an application by the Secretary.
Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product.
Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications.
Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.
Cosponsors 7
Members who signed on, in the order they did. Signatures ran from Feb 15, 2007 to Mar 19, 2007, with 5 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-LA | David Vitter | Original | Feb 15, 2007 |
| D-MI | Debbie Stabenow | Original | Feb 15, 2007 |
| D-NY | Hillary Rodham Clinton | Original | Feb 15, 2007 |
| D-VT | Patrick J. Leahy | Original | Feb 15, 2007 |
| R-ME | Susan M. Collins | Original | Feb 15, 2007 |
| R-MN | Norm Coleman | Mar 6, 2007 | |
| D-OH | Sherrod Brown | Mar 19, 2007 |
Actions 4
Everything that happened, newest first.
- Feb 27, 2007Star Print ordered on S. 623.
- Feb 15, 2007Introduced in Senate
- Feb 15, 2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2054-2058)
- Feb 15, 2007Sponsor introductory remarks on measure. (CR S2053-2054)
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 1038 | Access to Life-Saving Medicine Act | Identical bill | Feb 15, 2007 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative remedies
- Civil actions and liability
- Clinical trials
- Commerce
- Congressional reporting requirements
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Food and Drug Administration (FDA)
- Government Operations and Politics
- Health
- Injunctions
- Intellectual property
- Judicial opinions
- Judicial review
- Labeling
- Law
- Licenses
- Patent infringement
- Patents
- Pharmaceutical research
- Product safety
- Science, Technology, Communications
Text 1
Each version as it was printed, newest first.
- Feb 15, 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.