On the recordMay 2, 2007
I agree with my friend Senator Schumer, and note with gratitude that the HELP Committee began bipartisan discussions on how to accomplish this goal. And while I was disappointed that follow-on biologic legislation was not included during committee consideration of S. 1082, it was in good faith that I did not offer an amendment with the understanding that our bipartisan efforts would continue. As my colleagues and I move forward on this important effort, I think it is important to identify the key principles that must be contained in the legislation: We must provide the FDA with the authority and flexibility to approve biopharmaceuticals subject to a workable, abbreviated approval pathway that is efficient, effective and scientifically grounded. We must also include measures to ensure timely resolution of patent disputes, as well as adequate incentives for continued innovation.
Source
govinfo.gov




