H.R. 1427 (111th): Promoting Innovation and Access to Life-Saving Medicine Act

Mar 11, 2009 (111th Congress, 2009–2010)
Died (Referred to Committee)
See Instead:

S. 726 (same title)
Referred to Committee — Mar 26, 2009

Henry Waxman
Representative for California's 30th congressional district
Read Text »
Last Updated
Mar 11, 2009
52 pages
Related Bills
S. 726 (identical)

Referred to Committee
Last Action: Mar 26, 2009


This bill was introduced on March 11, 2009, in a previous session of Congress, but was not enacted.

Introduced Mar 11, 2009
Referred to Committee Mar 11, 2009
Full Title

To amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes.


No summaries available.

16 cosponsors (8D, 8R) (show)

House Energy and Commerce


House Judiciary

The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act.
Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product).
Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.
Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period.
Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes.
Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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