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HR 1427 111th Congress House Health Administrative remedies Child health Civil actions and liability Department of Health and Human Services Drug safety, medical device, and laboratory regulation Intellectual property Judicial procedure and administration Licensing and registrations Medical research

Promoting Innovation and Access to Life-Saving Medicine Act

Introduced: March 11, 2009 See on congress.gov
This bill died when the 111th Congress ended
It never became law before the 111th Congress (2009–2010) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 12, 2009
Referred to the Subcommittee on Health.
Mar 11, 2009
Referred to House Judiciary
Mar 11, 2009
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
Mar 11, 2009
Referred to House Energy and Commerce
Mar 11, 2009
Introduced in House
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 Plain-English summary Congressional Research Service

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.

What's happening now March 12, 2009

Referred to the Subcommittee on Health.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 1427: Promoting Innovation and Access to Life-Saving Medicine Act. 111th Congress. Open America. https://openamerica.io/bill/111-HR-1427/
MLA
"H.R. 1427: Promoting Innovation and Access to Life-Saving Medicine Act." 111th Congress, 2026, Open America, https://openamerica.io/bill/111-HR-1427/.
Bluebook (legal)
H.R. 1427, 111th Cong. (2026), https://openamerica.io/bill/111-HR-1427/.
Markdown link
[H.R. 1427: Promoting Innovation and Access to Life-Saving Medicine Act](https://openamerica.io/bill/111-HR-1427/)
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