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.


(As printed in the Congressional Record for the Senate on May 2, 2007.)