3.0.0 4016 2023-01-12T17:52:02Z 2023-01-12T17:52:02Z Senate S S 2006-09-29 109 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2006-09-29T21:56:37Z Access to Life-Saving Medicine Act 109 6257 HR 2006-10-02 Referred to the Subcommittee on Health. Related bill CRS 2006-09-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2006-09-29 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 2006-09-29 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2006-09-29 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2006-09-29 True Health Administrative remedies Civil actions and liability 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 Product safety Health 00 2006-09-29 Introduced in Senate 2007-01-12T19:18:17Z 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 biological product applications.

Sets forth provisions governing patent infringement claims against the license holder of a comparable product.

]]> Access to Life-Saving Medicine Act Display Title Access to Life-Saving Medicine Act Official Title as Introduced A bill to amend the Public Health Service Act to provide the licensing of comparable biological products, and for other purposes. Introduced in Senate IS Short Titles as Introduced Access to Life-Saving Medicine Act Introduced in Senate 2006-09-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s4016is/xml/BILLS-109s4016is.xml 2006-09-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.