Access to Life-Saving Medicine Act

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 15 February 2007

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2054-2058)

   Source: IntroReferral

2. 15 February 2007

   Introduced

   Sponsor introductory remarks on measure. (CR S2053-2054)

   Source: IntroReferral

3. 15 February 2007

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 27 February 2007

   Floor

   Star Print ordered on S. 623.

   Source: Floor

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 15 February 2007 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 15 February 2007

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 February 2007

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in Senate

  summary · EN · 15 February 2007

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Schumer, Charles E. [D-NY] · D · Sponsor
• Sen. Clinton, Hillary Rodham [D-NY] · D · Sponsor
• Sen. Vitter, David [R-LA] · R · Sponsor
• Sen. Collins, Susan M. [R-ME] · R · Sponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Sponsor
• Sen. Stabenow, Debbie [D-MI] · D · Sponsor
• Sen. Coleman, Norm [R-MN] · R · Cosponsor
• Sen. Brown, Sherrod [D-OH] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to → Access to Life-Saving Medicine Act