GovTrack’s Bill Summary
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H.R. 1548 (111th): Pathway for Biosimilars Act
- Introduced:
- Mar 17, 2009 (111th Congress, 2009–2010)
- Sponsor:
- Rep. Anna Eshoo [D-CA14]
- Status:
- Died (Referred to Committee)
The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.
Library of Congress Summary
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
3/17/2009--Introduced.
Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).
Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.
Prohibits a biological product from being evaluated against more than one reference product. Prohibits licensure under this Act of a biological product containing specified agents or toxins or a schedule I or II controlled substance unless the Secretary determines there would be no increased risk to the security or health of the public from licensing such a biological product. Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.
Provides for confidentiality of information received pursuant to this Act.
Sets forth provisions governing patent infringement actions related to this Act.
Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.
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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So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.
We’ll be looking for a source of summaries from the other side in the meanwhile.
The bill contains the following citations to other parts of U.S. law:
United States Code
The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)
- Title 21: FOOD AND DRUGS
- Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT
- Subchapter V: DRUGS AND DEVICES
- Part A: Drugs and Devices
- Section 355: New drugs
- Subchapter VII: GENERAL AUTHORITY
- Part C: Fees
- Subpart 2: fees relating to drugs
- Section 379g: Definitions
- Title 28: JUDICIARY AND JUDICIAL PROCEDURE
- Part VI: PARTICULAR PROCEEDINGS
- Chapter 151: DECLARATORY JUDGMENTS
- Section 2201: Creation of remedy
- Title 35: PATENTS
- Part III: PATENTS AND PROTECTION OF PATENT RIGHTS
- Chapter 28: INFRINGEMENT OF PATENTS
- Section 271: Infringement of patent
- Title 42: THE PUBLIC HEALTH AND WELFARE
- Chapter 6A: PUBLIC HEALTH SERVICE
- Subchapter II: GENERAL POWERS AND DUTIES
- Part F: Licensing of Biological Products and Clinical Laboratories
- Subpart 1: biological products
- Section 262: Regulation of biological products