May 2, 2007, 12:00 am ET - Amendment SA 1025 proposed by Senator Schumer.
May 2, 2007, 12:00 am ET - Amendment SA 1025 agreed to in Senate by Voice Vote.
Full Text of this Amendment
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.
(As printed in the Congressional Record for the Senate on May 2, 2007.)