Promoting Innovation and Access to Life-Saving Medicine Act

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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

D SchumerSponsor

9 cosponsors · 6 D, 3 R

6 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

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.

What it does: CRS summary · Introduced in Senate · Mar 26, 2009

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Promoting Innovation and Access to Life-Saving Medicine Act

Latest action (Mar 26, 2009): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Policy area: Health · Origin: Senate · Introduced: Mar 26, 2009

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.