3.0.0 623 2023-01-11T19:57:55Z 2023-01-11T19:57:55Z Senate S S 2007-02-15 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-02-15T20:05:41Z Access to Life-Saving Medicine Act 110 1038 HR 2007-02-15 Referred to the Subcommittee on Health. Identical bill CRS 2007-02-27 Senate Star Print ordered on S. 623. Floor 2007-02-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2054-2058) IntroReferral 2007-02-15 Sponsor introductory remarks on measure. (CR S2053-2054) IntroReferral B00100 9 Library of Congress 2007-02-15 Introduced in Senate IntroReferral 10000 9 Library of Congress S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. N C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2007-02-15 True V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2007-02-15 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2007-02-15 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2007-02-15 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2007-02-15 True C001057 Sen. Coleman, Norm [R-MN] Norm Coleman R MN 2007-03-06 False B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2007-03-19 False Health Administrative remedies Civil actions and liability Clinical trials Commerce Congressional reporting requirements Department of Health and Human Services Drug approvals Drug industry Food and Drug Administration (FDA) Government Operations and Politics Injunctions Intellectual property Judicial opinions Judicial review Labeling Law Licenses Patent infringement Patents Pharmaceutical research Product safety Science, Technology, Communications Health 00 2007-02-15 Introduced in Senate 2007-04-09T20:44:22Z 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.

]]> Access to Life-Saving Medicine Act Official Title as Introduced A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. Introduced in Senate IS Display Title Access to Life-Saving Medicine Act Short Titles as Introduced Access to Life-Saving Medicine Act Introduced in Senate 2007-02-15T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s623is/xml/BILLS-110s623is.xml 2007-02-27 Star Print ordered on S. 623. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.