HR 1038 · 110th Congress · Health

Access to Life-Saving Medicine Act

Introduced 2007-02-14· Sponsored by Rep. Waxman, Henry A. [D-CA-30]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2007-02-15)

Plain Language Summary

[AI summary unavailable — showing source text] 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 …

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (20)

16 Democrats4 Republicans