To express the sense of the Senate with respect to follow-on biologics.
What it does: Adds SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS at the end of the bill
Sen. Charles E. Schumer (D-NY)What it changes
1 change to S. 1082 · shown in the bill's text
Adds SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS at the end of the bill
Adds a sectionIn S. 1082 · Reported to Senate
If any provision of this Act, an amendment made this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstances shall not be affected thereby. Amend the title so as to read: "To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.".
Inserted: SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS.
Inserted: (a) Findings.--The Senate finds the following:
Inserted: (1) The Food and Drug Administration has stated that it requires legislative authority to review follow-on biologics.
Inserted: (2) Business, consumer, and government purchasers require competition and choice to ensure more affordable prescription drug options.
Inserted: (3) Well-constructed policies that balance the needs of innovation and affordability have broad bipartisan support.
Inserted: (b) Sense of the Senate.--It is the sense of the Senate that--
Inserted: (1) legislation should be enacted to--
Inserted: (A) provide the Food and Drug Administration with the authority and flexibility to approve biopharmaceuticals subject to an abbreviated approval pathway;
Inserted: (B) ensure that patient safety remains paramount in the system;
Inserted: (C) establish a regulatory pathway that is efficient, effective, and scientifically-grounded and that also includes measures to ensure timely resolution of patent disputes; and
Inserted: (D) provide appropriate incentives to facilitate the research and development of innovative biopharmaceuticals.
Original wording
At the end of the bill, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 1025. Mr. SCHUMER (for himself, Mrs. Clinton, Mr. Enzi, Mr. Hatch, and Mr. Kennedy) proposed an amendment to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows:
At the end of the bill, add the following:
SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS.
(a) Findings.--The Senate finds the following:
(1) The Food and Drug Administration has stated that it requires legislative authority to review follow-on biologics.
(2) Business, consumer, and government purchasers require competition and choice to ensure more affordable prescription drug options.
(3) Well-constructed policies that balance the needs of innovation and affordability have broad bipartisan support.
(b) Sense of the Senate.--It is the sense of the Senate that--
(1) legislation should be enacted to--
(A) provide the Food and Drug Administration with the authority and flexibility to approve biopharmaceuticals subject to an abbreviated approval pathway;
(B) ensure that patient safety remains paramount in the system;
(C) establish a regulatory pathway that is efficient, effective, and scientifically-grounded and that also includes measures to ensure timely resolution of patent disputes; and
(D) provide appropriate incentives to facilitate the research and development of innovative biopharmaceuticals.
Legislative Activity
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Senate amendment submitted
May 2, 2007
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Senate amendment submitted
May 2, 2007
Senate amendment proposed (on the floor): Amendment SA 1025 proposed by Senator Schumer.(consideration: CR S5485; text: CR S5485)
May 2, 2007
Senate amendment agreed to: Amendment SA 1025 agreed to in Senate by Voice Vote.
May 2, 2007
Amendment SA 1025 proposed by Senator Schumer. (consideration: CR S5485; text: CR S5485) To express the sense of the Senate with respect to follow-on biologics.
May 2, 2007
Amendment SA 1025 agreed to in Senate by Voice Vote.
May 2, 2007