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HR 1956 110th Congress House Health Biotechnology Commerce Congressional reporting requirements Deceptive advertising Drug approvals Drug industry Drugs Federal advisory bodies Government Operations and Politics Labeling Licenses Proteins Science, Technology, Communications

Patient Protection and Innovative Biologic Medicines Act of 2007

Introduced: April 19, 2007 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 20, 2007
Referred to the Subcommittee on Health.
Apr 19, 2007
Referred to the House Committee on Energy and Commerce.
Apr 19, 2007
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now April 20, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2