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Public Statements

Prescription Drug User Fee Amendments of 2007

Floor Speech

Location: Washington, DC



Mrs. CLINTON. I thank the Senator for his leadership on generic drugs and for his presence here today. In 1984 when the Hatch-Waxman generic drug law was written, very few biologic drugs existed and there was no need to empower the FDA to approve lower cost versions of existing biologic drugs. This is no longer the case and it is time to enact legislation that will allow the FDA to approve safe and effective follow-on versions of biotech drugs.

Mr. KENNEDY. I thank my colleagues and I agree that creating a pathway for follow-on biologics is an important issue worthy of our consideration.

Mr. SCHUMER. I say to Chairman KENNEDY, the junior Senator from New York and I stand ready to offer a bipartisan amendment to this bill that would establish a pathway for follow-on biologic drugs. We would prefer to work with you, and with the distinguished Senators from Wyoming and Utah. To that end, we would like to work together to discuss a pathway that protects patient safety, enables consumer access to more affordable biologic drugs, and provides appropriate incentives for continued innovation of lifesaving drugs.

Mrs. CLINTON. 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.

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