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Prescription Drug User Fee Amendments Of 2007--Continued

Floor Speech

Location: Washington, DC

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007--Continued -- (Senate - May 01, 2007)


Mr. KENNEDY. Mr. President, this basically incorporates a number of the adjustments and changes that we had indicated during the course of our markup. We had a number of amendments that were offered. We indicated to the members we would try to work through some of the points that were raised. I commend our staffs on both sides who have been diligent in doing so.

These are alterations, changes that are known to the majority and the minority and all the staff members. Later on in the discussion and debate we can go into some in greater detail. Most of them are clarifications. Some of them are simplifications. I think all of them are worthy and justified, and I think they help to strengthen the legislation. So we are very grateful to all of our colleagues on our committee who offered the amendments, and, most particularly, we are very grateful for their willingness to work with us to try to work through these alterations and changes.

Mr. President, this legislation, as was pointed out in the excellent statement made by our friend and colleague from Rhode Island, Mr. Reed, and others, is complex, but it is incredibly important in terms of American families, most precisely with regard to drug safety. We have reviewed those provisions. Senator Enzi made an excellent presentation yesterday. We tried to go through those in some detail yesterday afternoon. I might go through some of those again this afternoon.

But we want our Members to know we are ready to consider amendments. We know there are several that are just about ready to be offered. We urge those who are considering bringing them to the floor, let's begin the debate and discussion. We have one or two that are still being worked on. So even though it does not appear like we are making progress on this legislation at the moment, progress is being made in making sure we are going to have strong FDA reauthorization legislation. But we do hope we can get to the amendments very soon, and we expect to be able to do so.


Mr. KENNEDY. Mr. President, I am pleased to continue working with my colleague from Kansas, Senator Roberts, and my colleague from Iowa, Senator Harkin, on the important issue of direct-to-consumer advertising.

We have to strike an important balance between seeing that consumers get accurate information on drug safety and seeing that we do not improperly restrain free speech.

Senator Harkin has a proposal to add safety information to drug ads. Senator Roberts has an idea to allow FDA to impose fines for inaccurate ads. Our bill includes a moratorium--only to be used in rare cases--on DTC ads. The IOM went further and recommended a moratorium on DTC for all new drugs. We rejected that recommendation due to the first amendment concerns but included more limited authority that we believe meets the constitutional test.

Still, some have raised concerns about our current proposal, and we take those concerns seriously. We will continue to work on this important issue with our colleagues and constitutional experts. I think we are making progress through the afternoon and, hopefully, by tomorrow we will have some recommendation.


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