H.R. 6257 · 109th Congress
Access to Life-Saving Medicine Act
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Never voted on. It didn't reach a floor vote before the 109th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
WaxmanSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of a comparable biological product based on its similarity to a previously licensed biological product (the reference product).
What it does: CRS summary · Introduced in House · Sep 29, 2006
Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of a comparable biological product based on its similarity to a previously licensed biological product (the reference product). Allows a person to file an abbreviated comparable product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the comparable 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 comparable 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. Provides market exclusivity to such an interchangeable product.
Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable product applications.
Sets forth provisions governing patent infringement claims against the license holder of a comparable product.
Amends the Internal Review Code to allow a tax credit for qualified clinical testing expenses.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Access to Life-Saving Medicine Act
Latest action (Oct 2, 2006): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Sep 29, 2006
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.