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Public Statements

Prescription Drug User Fee Amendments Of 2007

Floor Speech

Location: Washington, DC



Mr. KENNEDY. Mr. President, we now have an agreement that we are going to vote on cloture on the Dorgan amendment. The Senator from North Dakota will be here to speak on that. He has a half hour. To bring our colleagues up to date, we have made very good progress during the evening, clearing matters with the Members. There are still a number of items that we will want to accept. We will indicate to the Members the topical areas so they will be familiar with the areas that we are moving ahead on. But we have narrowed the areas of controversy to probably four or five important areas where we may very well have votes during the day. The rest we will announce the agreements that have been made with the particular Senators on these issues.

We want to thank all of our colleagues. This has been very constructive. A number of these suggestions and ideas are extremely valuable. We will tell our colleagues the areas and the content of these agreements as we move on through the day.

We are in touch with a couple of Senators so we will be able to make a judgment decision at the conclusion of this vote on the cloture. We will be ready to go so we will not miss any opportunity to make progress on the bill.

I thank the Senator. The Senate will now debate the underlying cloture motion.


Mr. KENNEDY. Mr. President, the Kohl amendment seeks to end abuse of the system for bringing generic drugs to the market. Under Hatch-Waxman, there is a sensible and balanced system for rewarding generic drug makers who enter the market first, but some companies have subverted this balanced system.

Instead of allowing market forces to bring medicines to consumers at lower prices, companies collude to deny consumers the benefit of the lower cost drugs through ``reverse payments.'' Essentially, there is a payoff from the brand drug companies to the generic companies to split the benefits of the incentives provided under Hatch-Waxman.

Everyone benefits under these arrangements, except consumers. Brand drug companies get further protection from competition, generics get payoffs and a guaranteed market. Only consumers get left behind, stuck with high prices and lesser competition.

The Judiciary Committee reported legislation on this important issue. I commend Senator Kohl for his leadership. I know Senator Specter and Senator Hatch have important recommendations. I am sure we can work these matters out in a proposal to include the best ideas.

We understand there are members of the Judiciary Committee who may want to speak to this amendment. I would hope the Senator would withhold further comments until we can see if there are members of the Judiciary Committee who want to address this amendment. I hope we will be able to include it and adopt it.


Mr. KENNEDY. Mr. President, to review where we are in this debate and discussion, we will be meeting again on Monday next, making critical choices and decisions about the way we are going to proceed. We have made good progress over the course of this week. Some of us were hopeful that we would be able to move toward the completion of this legislation. But this legislation is enormously complex and enormously important.

We have made, as I say, good progress. We have a number of different areas we have worked through over the period of these past days. We will propose a managers' package and we will make the final judgments about the determination of this legislation on Monday next.

Again, we thank all of our colleagues who have worked with us on the legislation. Very quickly, to say again why this legislation is important, and that is because, as we know, the FDA effectively protects the prescription drug supply and our pharmaceutical supplies, medical devices, vaccines, food supply and cosmetics; about 25, almost 30 percent of all of the consumer products. So, it is enormously important that we have the FDA be the gold standard to protect American families, particularly with regard to prescription drugs and with regard to food and other items as well.

So very quickly, and finally, to review exactly what this legislation does and why it is so important, why it is so urgent, why it is so necessary--and this legislation falls in that category--that is why we are urging that we reach conclusion on Monday next.

One of the notorious recent examples of fear that took place in many households this past year, over the period of the last year, was the Vioxx scare, the whole issue and question about those whose lives may very well have been shortened because of Vioxx.

The best way to illustrate what we are talking about in terms of patient safety is how this legislation would deal with a future kind of a Vioxx that might endanger the health of our fellow citizens.

First, can the FDA quickly detect a safety problem with a drug? With the Vioxx situation, the answer was no. Now we have a completely new system, a sort of an information technology system with regard to post-marketing surveillance. We draw on all of the public as well as private systems--the Mayo system, the veterans system, the myriad different systems that will be collecting information. It will be collected in one central place--the FDA--so the Food and Drug Administration can demonstrate that there is a safety problem. There will be notice for the Agency.

Can the FDA require the label changes to warn of safety problems? Under the existing circumstances, there was a negotiation for some 14 months before they were able to resolve that issue. Finally, the drug was withdrawn by the company. If the company doesn't deal with the Agency, the Food and Drug Administration has the authority and power to withdraw the approval and effectively repeal the drug. But that has very important safety considerations because there may be certain populations where this particular drug may be suitable. That is probably true with Vioxx. It is not suitable for the general population but suitable for a particular population. What this does is give the FDA the kind of opportunity for labeling changes to warn of safety problems. It has other alternatives which I will refer to lower in the chart.

Are companies stopped from hiding safety problems? It is extremely difficult because we include the publication of clinical trials so they will be available to the public. This transparency included in this legislation is enormously important. The value of clinical trials is not only important from a safety point of view but also for individuals who are affected by disease and illness. They may make a judgment that they want to enroll in a particular clinical trial and try to remedy their particular health challenge. There will be the registry and the opportunity for them to do that. That has not existed in the way we have done this. That opens up enormous kinds of opportunities for many people who have many of the illnesses and sicknesses we know affect so many of our families. So, we have the safety provision and also the opportunity for people who have those illnesses and diseases to take advantage of this program.

Does the FDA have flexible tools to enforce safety decisions? The answer is yes. This was described well by my friend from Wyoming, Senator Enzi. He talked about the toolbox available to the FDA. It can be included in labeling. It can be included in terms of training of various personnel to administer the drug. It can be included in terms of specialized targeting, particularly groups in the medical profession who have the skills to dispense those drugs. There are a variety of different tools that are in there that do not exist today.

Finally, is the FDA the gold standard for protecting the public health and assuring access? We believe the answer is yes. These are practical examples of how we protect families.

We have another chart which makes this point as well. We had an excellent study done by the Institute of Medicine, an extraordinary group of individuals who reviewed the powers of the FDA and made recommendations. This chart shows we have incorporated in this legislation, by and large, the recommendations made by the Institute of Medicine, with respect to drug safety. We built in the epidemiology and the informatics capacity to improve post-marketing assessment, using information technology; to make public the results of the post-clinical trial; to regularly analyze post-market study results; to give FDA clear authority to require post-marketing risk assessment and management. If there are additional kinds of requirements in terms of the drug itself, the FDA will have that authority and give better enforcement tools. We also include some civil penalties to make sure this is going to be enforced--that is important--and conduct regular evaluation of a new drug's safety profile. We will continue with post-marketing surveillance. This will be a continuing process to protect the American consumer. It is an enormously important concept to implement this. We will also increase drug safety resources available to the FDA. We have done all of these in this legislation.

We have enhanced the Office of Science, and we have improved significantly the conflict of interest and other provisions.

This gives you some idea. We have an excellent statement from groups who represent 30 million patients: This legislation gives the FDA the ability to continue to study the safety of drugs after approval, flexible enforcement tools necessary to ensure compliance with these new safety protections, and additional funding to support these new activities. Allowing the Agency to act on clear safety signals could actually allow the FDA to approve drugs more quickly, knowing it will have the ability to respond on behalf of patients if safety concerns appear post-market.

That is important. With breakthroughs in the life sciences and different opportunities that are now available, the Agency will feel more comfortable in approving drugs which they may have a speck of doubt about, but they will know that with the kind of review processes we have insisted on in this legislation, they can get on the market quicker and that it can improve the quality of health and safe lives. This is very important: ``knowing it will have the ability to respond on behalf of patients if safety concerns appear post-market.''

This is from the Alliance for Drug Safety that represents 30 million patients, a very solid endorsement of what this legislation is all about.

We have done a similar protocol with regard to food safety as well, of the importance of surveillance. As we would with some bioterrorist threat, it is enormously important that we understand what is happening in a number of these countries around the world, early survey labs, and the follow-on provisions that we have included.

A final point, we have had a debate with regard to the differential that has taken place in the different countries. The presentation has been made. There has now been the pending Dorgan amendment which recognizes this disparity to make some adjustments on this issue in terms of the medicines.

We will move ahead on this. We have other items which have been proposed by our colleagues and on which we are prepared to make some recommendations. We have worked very closely during the evening, early morning with Senator Enzi and our colleagues. We are hopeful we will be able to see a conclusion of this legislation, which is so vitally important to the American people during the early part of next week.

Again, we are enormously thankful to all and extremely grateful to my friend and colleague, Senator Enzi. We look forward to a good discussion and debate and continued progress on this very important bill at the beginning of the week.


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