H.R. 1956 · 110th Congress
Patient Protection and Innovative Biologic Medicines Act of 2007
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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InsleeSponsor25 cosponsors · 24 D, 1 R
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Davis
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Kind
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Smith
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Crowley
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Tauscher
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Hooley
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Richardson
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Sestak
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Hinojosa2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was…
What it does: CRS summary · Introduced in House · Apr 19, 2007
Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.
Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.
Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.
Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.
Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.
Requires the Secretary to establish a Similar Biological Products Advisory Committee.
Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Patient Protection and Innovative Biologic Medicines Act of 2007
Latest action (Apr 20, 2007): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 19, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.