Prescription Drug User Fee Amendments Of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

Mr. SCHUMER. Mr. President, I rise to engage in a colloquy with my colleagues from Utah, New York, Massachusetts, and Wyoming on biologics. I thank every one of them for their cooperation and help as we move forward.

Mr. President, I rise today with my colleagues to speak about biologic drugs, a large and growing sector of the drug market. Biologic drugs can cost tens of thousands of dollars a year for a single patient, and treat devastating diseases such as cancer and its complications. There is currently no clear pathway for lower cost competitors to biologic drugs to enter the market, as there is for generic versions of traditional chemical drugs. I have introduced a bill to create such a pathway. I am glad to see my friends Senator Kennedy, Senator Enzi, and Senator Hatch on the floor to discuss this issue with us. I yield to my colleague from Utah.

Mr. HATCH. I am happy to discuss this issue with my colleagues. As they are aware, this has been my high priority for a number of years, given that I am the author with Representative Henry Waxman of the Drug Price Competition and Patent Term Restoration Act--or ``Hatch-Waxman''. The Schumer-Clinton bill, which I know has been introduced by Representative Waxman in the House, is an important contribution to this dialogue. I want to work to reach an acceptable compromise on an expedited basis, and it is clear to me it must be a bipartisan effort.

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.

Mr. KENNEDY. I assure the Senators from New York that the conference report on the FDA Revitalization Act will include a pathway to follow-on biologics that has been reported out of the HELP Committee and that is acceptable to the Senators from New York. I plan to hold a markup on this issue on June 13.

Mr. ENZI. The heart of the debate is how to construct a regulatory framework so that biologic drugs can be safely available under an accelerated pathway. It is more difficult to approve biosimilars than to approve generic versions of typical drugs. The balance we are trying to find is a compromise that promotes access with innovation, while also maintaining the high standards of safety at the Food and Drug Administration.

Biologics are complex molecules modeled after key processes occurring daily within the human body. One analogy is that if a typical drug was a 3 bedroom, 2 bath starter home, a biologic would be a skyscraper. The size, scope and complexity are completely different. The nomenclature is, too. As key scientists stated at our HELP Committee hearing on this topic, these are not generic biologics but biosimilars.

With many drugs, we can describe their structure with a high degree of precision--but not with follow-on biologics. You can't make an exact ``copy'' of a biologic, like you can for most typical generic drugs. For example, if I was to try to build the skyscraper of a biologic without the blueprints, as any generic company would need to do to create a follow-on biologic, I would have to ensure that every copy was identical or there could be fatal results.

Because of this, science must be an essential part of any safety standard. One piece out of place would cause the entire structure to fall.

But to be clear, a safe pathway for an accelerated approval process for biologics, that also preserves innovation, is possible. It is not just me who believes it--the FDA, generic and pharmaceutical industries have all said so as well. I have been working across party lines with Senators Hatch, Kennedy and Clinton to develop legislation that does just that. Our staffs have been working tirelessly on this topic: individually meeting with experts and stakeholders; and as a group, talking with experts from the United States and global leaders. After all, we want the same end result--legislation that ensures medicines are safe and affordable, and that medical innovation continues to flourish.

I have a track record of working across party lines to build consensus and find common ground on tricky legislative issues. I know that with a little more time, and through regular order, we will develop a bipartisan package that accomplishes our common goals.

I concur with the chairman and am committed to moving a bipartisan bill through the HELP Committee in the near future with the goal that it can be joined with the conference on the FDA Revitalization Act.

Mr. HATCH. I look forward to working with my colleagues to include bipartisan follow-on biologics legislation in the conference agreement on the FDA Revitalization Act. It is clear that consumers would benefit tremendously from an abbreviated pathway for consideration of biosimilar products. Any effort, though, must be based on a sound understanding of the science involved and it must contain incentives for development of the innovator products which will be copied.

Mr. SCHUMER. I thank my colleagues for these commitments. I look forward to working together with Chairman Kennedy, Senator Enzi, Senator Clinton, and Senator Hatch to develop workable legislative language that can be scheduled for a June 13 markup in the HELP Committee and included in the FDA Revitalization Act conference report.

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