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 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.

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Timeline

1. 29 September 2006

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

2. 29 September 2006

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

3. 29 September 2006

   Introduced

   Introduced in House

   Source: IntroReferral

4. 29 September 2006

   Introduced

   Introduced in House

   Source: IntroReferral

5. 2 October 2006

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 29 September 2006 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 29 September 2006

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 29 September 2006

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 29 September 2006

  Open at official source

Sponsors

• Rep. Waxman, Henry A. [D-CA-24] · D · Sponsor
• Sen. Brown, Sherrod [D-OH] · D · Sponsor
• · hsif00 · Standing
• · hswm00 · Standing
• · hsju00 · Standing

Related records

• related to ← Access to Life-Saving Medicine Act