PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)
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Mr. DODD. Mr. President, let me first begin by thanking Senator Kennedy and Senator Enzi for including the Best Pharmaceuticals for Children Act and the Pediatric Medical Device Safety and Improvement Act in the bill before us. I congratulate them, particularly Senator Kennedy for his efforts of putting all this together, this major legislation which is going to be so important for the health and well-being of all our citizenry. I am very grateful to him, and to Senator Enzi as well, for leading the minority on this issue and making it possible for us to be here today to discuss these issues.
My friend from Colorado and I worked together on this issue. I appreciate the comments about the effort we made over the past decade or more to try to do what this bill was designed to do and has done, and that is to increase the clinical trials and testing of products used in our younger Americans--children.
In too many cases, prescription drugs were being tested for adults, and there was an assumption that a smaller dosage of that product would be all that was necessary to take care of children. Obviously, that was not the case, as we heard in significant testimony over the years.
Countless hours have gone into the work on this legislation. The Presiding Officer has been a tremendous help. I thank him for his efforts, along with others on this committee helping us put this together.
It must be an Ohio tradition. As he has heard me say on occasion, Senator Brown has been tremendously supportive, working on this issue. He was active on the issue when he served in the other body, and he brought his talents and knowledge to the issue when he arrived here recently. His predecessor, Senator DeWine, was my cosponsor on this bill for a decade, on a bipartisan basis putting the legislation together that has produced the results which have been identified by Senator Allard and Senator Enzi already this morning.
We find ourselves here having worked very carefully together on a bipartisan basis for more than a decade to craft legislation. None of us are claiming perfection here. The idea was to try to induce the industry to step forward and do something they had not done before--to test their products in children. We were not certain when we started out how this would actually work. Ten years ago, we saw a situation where the majority of drugs being used in children were not being tested for their use.
Children are not simply little adults. The results of drug studies conducted under the Best Pharmaceuticals for Children Act have shown they should not be treated as such. The initiative contained in the bill before us on pediatric medical devices is a similar effort to ensure children are not left behind as cutting-edge research and revolutionary technologies for medical devices advance.
Senator DeWine, as I mentioned, and I authored this bill more than a decade ago, at a time when only 11 drugs on the market that were being used for children had actually been tested and studied for that use. Prior to the enactment of this legislation a decade ago, pediatricians were essentially flying blind because they lacked information regarding the safety and effectiveness of drugs they were prescribing. It was often the children who suffered the most.
What we have learned over this past decade after 10 years of experience is that children have been exposed to ineffective drugs, ineffective dosing, overdosing, or drug side effects that were previously unknown. In 10 years, nearly 800 studies involving more than 45,000 children in clinical trials have been completed as a result of this legislation. Useful new pediatric information is now part of product labeling for more than 119 drugs.
In sum, there has been a 20-fold increase in drugs studied in infants, children, and adolescents as a result of the legislation I authored 10 years ago. Children with a wide range of diseases such as HIV/AIDS, cancer, allergies, asthma, neurological and psychological disorders, and obesity can now lead healthier and more productive lives as a result of new information about the safety and efficacy of drugs they use to treat and manage their diseases when previously there was none. This successful program for children will expire on the 30th of September unless we reauthorize it.
I have spent months crafting a proposal to reauthorize this legislation, which is now reflected in the underlying bill. It had been my hope that this initiative would continue in that bipartisan tradition that began more than a decade ago. Fashioning legislation when there are 100 of us here, trying to come up with ideas, and yet balance disparate views and opinions. There are some, frankly, who would have no periods of exclusivity and believe the industry ought to be doing this as a matter of obligation to one out of four Americans. You have heard from others who think we ought to provide extended periods of exclusivity, longer than 6 months. It is not easy to fashion these compromises here, where you can put something together that does what we want to do, all the while ensuring that the program can continue to generate more benefits than were originally contemplated. There has to be some limitation in terms of how we deal with all this.
I thank Senators Kennedy, Harkin, Bingaman, Murray, Reed, Clinton, and Brown, who all cosponsored the legislation I introduced which, as I previously mentioned, has been incorporated on this bill.
Mr. President, I will ask unanimous consent that these letters be printed in the Record so my colleagues will know the bill we are considering is not something we threw together haphazardly. This was major, extensive work with major organizations in this country that spend every waking hour working on children's diseases and issues that affect their health. I am grateful to the AIDS Alliance for Children, Youth & Families; the American Academy of Child and Adolescent Psychiatry; American Academy of Pediatrics; the American Brain Coalition; American Pediatric Society; the American Psychiatric Association; the American Thoracic Society; the Arthritis Foundation; the Association of Medical School Pediatric Department Chairs; Children's Cause for Cancer Advocacy; Elizabeth Glaser Pediatric AIDS Foundation; National Association of Children's Hospitals; National Organization for Rare Disorders; Society for Pediatric Research--the list goes on.
I ask unanimous consent to have printed in the Record two letters from this myriad of organizations which every day are involved with children's health and are strong advocates of what we are doing here and respectfully disagree with the amendment offered by Senator Allard today.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
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Mr. DODD. To anyone offering to flyspeck this proposal and offer variations to it, I would say that months and months have gone into this legislation which we think has had the dual effect of ensuring that the ramifications of expanding the length of exclusivity, as some have proposed, have been carefully considered along with proposals to limit the length of exclusivity to 3 months for all drugs, as others have proposed. The bill before us balances many viewpoints on this program and is a proposal that 15 major organizations involved with the effort strongly support.
Throughout the 10-year history of the Best Pharmaceuticals for Children Act, Congress has recognized the need to ensure it strikes the appropriate balance between the cost to consumers and benefits to children. By instituting a 5-year sunset in both the original legislation in 1997 and the first reauthorization in 2002, Congress was acknowledging the ongoing need to evaluate the cost of the incentive under this act to consumers in relation to the benefit of having medications properly studied and labeled for children.
The 6-month incentive of exclusivity has been very successful in generating pediatric studies. Yet after 10 years, experience and data have shown us that for a small number of drugs, pediatric exclusivity has far exceeded the carrot that was designed to encourage people to move forward.
In February of this year, the Journal of the American Medical Association published a study of the profits drug manufacturers received from the additional 6 months of pediatric exclusivity.
The study found that most of the drugs studied under the Best Pharmaceuticals for Children Act in recent years received relatively modest returns. In fact, data shows that many drugs came close to breaking even with respect to financial returns on investment for conducting pediatric trials. In one place they may have had a negative return.
However, the study also found, and I quote them here, that ``the pediatric exclusivity program overcompensates blockbuster products from performing clinical trials in children.''
S. 1082 contains a very reasonable, workable mechanism to address cost concerns. By adjusting exclusivity from 6 months to 3 months only for those products with U.S. sales over $1 billion, I think S. 1082 can address consumer concerns about excessive profits without jeopardizing the extraordinary benefits of this legislation.
I don't think it is too much to ask. That is why we have the sunset provisions in this program, to be able to go back and analyze how this is working every 5 years. So for those products in excess of a $1 billion, we shorten exclusivity. I am satisfied.
Pfizer, a leading drug company in this country, supports this proposal. The producer of the largest blockbuster drug in the world says this is a good compromise. Why are my colleagues having a hard time? If a major drug company who has benefitted under this exclusivity and manufactured blockbuster drugs says this bill is a sound compromise, what is the problem my colleagues have with this proposal?
If Pfizer, a company that has benefitted from this program says this balance is a healthy one, why can't my colleagues be happy with it?
This bill is a good bill. It has done a good job for people. But let's remind ourselves that we also have a responsibility to consumers. And when consumers find themselves in a situation where they can't afford lifesaving medicines, then it is time for us to strike a balance. This bill has a sunset provision in it. I am for the sunset provision. I am for it because we need to come back again in 5 years and assess where we are on this issue rather than make a determination that in perpetuity this is a program and a balance that makes sense forever.
According to the Congressional Budget Office, eliminating the exclusivity adjustment, as the amendment offered by my colleague from Colorado would do, would increase the cost of exclusivity to the Federal Government by $50 million over 10 years. So in addition to the consumers, taxpayers are going to be asked to pay an additional $50 million under the Allard amendment.
Again, if we have drug companies saying they think this proposal is a good balance, why are we adding a $50 million pricetag to the taxpayers with the Allard amendment, not to mention the cost of these drugs increasing as a result of extending exclusivity from 3 months to 6 months for products with sales in excess of $1 billion?
As I said, this is something I have worked on for a long time in a bipartisan fashion: to strike a balance as we've tried to do for 10 years between benefits to children and cost to consumers. To now say all of us who have worked on this program are wrong, all of the organizations involved with children's health are wrong, and drug companies that have benefitted from this program are wrong--but we know best. We know best. We think those billion-dollar products deserve to be protected. We think the taxpayers should foot the $50 million bill and the cost of these drugs are irrelevant in this debate. Well, they are not irrelevant.
We may do great damage to something we are trying to achieve after a decade of hard work on a bipartisan basis to put this together. I say respectfully to my friend from Colorado and the Senator from Wyoming, we have worked hard to strike these balances. It is not easy. These are complicated issues. It requires cooperation on both sides of the aisle to get the job done. That is what I have done for a decade with Members of that side of the aisle to see to it that we have a good, strong bill. The result is a program which has gone far beyond what we anticipated might happen.
The slight adjustment we have made after analyzing this bill after 10 years is little to ask. If one of the largest beneficiaries of the program is satisfied, and if the organizations who support this program believe it is all right, why are we adding a $50 million pricetag and asking consumers to pay more?
I urge my colleagues to reject the Allard amendment when the vote occurs. I thank Senator Kennedy and others who have worked so hard to make this possible. This is a very important piece of legislation, and one that can do an awful lot of good. The amendment offered by my colleague from Colorado puts that at risk. Our children in this country deserve better than what he is offering, which is to try to break up the delicate balance I have tried to put together for a decade.
Mr. President, I yield the floor.
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Mr. DODD. Mr. President, if I may, I would like to divide my 10 minutes, and I would like to spend a few minutes on another part of the bill, the Pediatric Medical Device Safety and Improvement Act.
I thank Senator Kennedy and Senator Enzi for including this bill which I authored in the underlying legislation.
The pediatric medical devices provision of the underlying bill is not subject to an amendment, but I want my colleagues to know what we have done with this provision, which is a complementary piece of legislation dealing with a similar set of issues as under the Best Pharmaceuticals for Children Act. That is, ensuring that medical devices used in children are safe and designed specifically for children. One of the fundamental hurdles with respect to children is that the market for products designed for them is relatively small. However, I believe the proposals in the underlying bill will make a huge difference in the lives of children.
This initiative provides a very comprehensive approach to ensuring that children are not left behind as cutting-edge research and revolutionary technologies for medical devices advance.
Like drugs, where for too long children were treated like small adults and were just given reduced dosages, many essential medical devices used by pediatricians are not designed or sized for children, and that has been the case for many years. Pediatric providers have had to resort to jury-rigging or fashioning makeshift device solutions for pediatric use. When that is not an option, providers may be forced to use more invasive treatments or less effective therapies. This legislation addresses the need to promote pediatric device development by providing incentives to manufacturers while at the same time equipping the Food and Drug Administration with appropriate authority to monitor and ensure the postmarket safety of medical devices used significantly in children.
One such example which highlights the need for this legislation is a device known as the Vertical Expandable Prosthetic Titanium Rib, a device invented, developed, and brought to market by Dr. Robert Campbell, Professor of Orthopaedics at the University of Texas Health Science Center. Dr. Campbell appeared before the Health, Education, Labor and Pensions Committee in late March and testified about the arduous 14 years it took to bring the titanium rib to market. Dr. Robert Campbell made remarkable breakthroughs with this technology but the hurdles he faced were, at times, seemingly insurmountable.
I want to put up a photograph of a boy named Devin Alvarez, of Hialeah Gardens, Florida, which shows the remarkable difference this device has made for him. Devin was born with six ribs missing and a very small left lung and kidney. At birth, the doctors did not believe he was going to survive his first night. In May 2002, Devin underwent titanium rib implant surgery and the curve of his spine was reduced to 45 degrees. Devin stood straight for the first time in his life and, at present, Devin is a very typical 9-year-old boy who enjoys playing sports such as golf and baseball.
Again, remarkable ideas for pediatric medical devices happen regularly, but the incentives to transform ideas into new FDA-approved devices simply don't exist. So the motivation for the Best Pharmaceuticals for Children Act legislation 10 years ago dealing with pharmaceutical products for children is the same motivation behind this legislation--to encourage the medical device industry to develop and to engage in the kind of research to allow these technologies to emerge.
In describing the pediatric medical devices bill which is now included in this legislation, Dr. Campbell, who has been so instrumental in all of this, said:
This bill represents an historic step forward for children's medical and surgical devices similar to those steps taken on drugs. It will help future medical inventors of pediatric devices to avoid my mistakes and my frustrations so that they can get their devices ``off the napkin,'' if you will, and into the pediatric patients who need them, in a safe and timely fashion.
I thank my colleagues from Massachusetts and Wyoming for working hard to make sure this will be a part of the underlying bill. I am grateful to them. It is my understanding that concerns have been raised by some in the medical device industry regarding a particular provision of the bill related to equipping the Food and Drug Administration with authority to ensure the safety of medical devices in children once they are already on the market.
The provisions in the bill mirror the recommendations made by the Institute of Medicine in its 2005 report on pediatric medical device safety. The Institute of Medicine found serious flaws in the current postmarket safety surveillance of these devices and the provisions in my bill correct those serious flaws. I am disheartened by those who would attempt to deprive children and physicians with information that pertains to device safety.
I think we have made some tremendous advances for children and their families in this legislation.
Mr. President, I ask unanimous consent that relevant material relating to the medical device provision of this legislation be printed in the Record.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
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Mr. DODD. Mr. President, let me go back, if I can, to my proposal on the Best Pharmaceuticals for Children Act and the objections raised by my colleague from Colorado to it. Just for the record and so we understand what we are talking about, according to a study recently published in the Journal of the American Medical Association that looked at the costs and benefits of these pediatric trials. It showed that the overwhelming majority of drugs studied under this incentive program are not blockbusters.
In fact, the study found that less than 20 percent were. That leaves 80 percent of drugs completely unaffected by the underlying bill which the Allard amendment seeks to amend. To be clear, the proposal in the underlying bill that would adjust exclusivity from 6 months to 3 months affects less than about 20 percent of drugs studied under this program. Using data from this recent study, 80 percent of drugs studied under BPCA--those which do not fall into the blockbuster category--the 6 months' exclusivity would remain unchanged. It doesn't change that at all; only in cases where there has been over $1 billion in prior year drug sales will the underlying bill change the exclusivity to 3 months.
This is to strike a balance. Obviously, I feel very strongly, having authored this legislation, about ensuring that appropriate clinical trials occur to protect children's health. Our notion was, when we wrote the legislation 10 years ago, that the 6 months of exclusivity would be the carrot that would incentivize the industry to go forward. There were some concerns expressed at the time that 6 months wasn't going to be anywhere near enough and that we would need more exclusivity. Some in the industry suggested a year or even 3 years of exclusivity. We settled on 6 months as the appropriate balance at the time.
What happened, of course, is we had this wonderful explosion of work that occurred. It resulted in nearly 800 clinical trials involving more than 45,000 children, with new pediatric labeling information on more than 119 drugs where previously there was none. I recall the debate on this program ten years ago very well, the industry said: Six months is never going to be enough; none of us will step up to the plate on this. And they really argued very strenuously for something longer than the 6 months. In fact, the 6 months has worked well, and almost all requests issued to drug companies to conduct pediatric trials under this program have been accepted.
What I have had growing concern about is the 20 percent of drugs receiving exclusivity where the profit realized as far exceeded the carrot intended to provide to drug companies. So to strike that balance between the cost to taxpayers and the benefits to children, we are saying that where sales of a drug being studied under this program exceed $1 billion in prior years, the company can get 3 months' exclusivity.
I don't know what the right answer will be on this issue. Neither me nor my colleague from Oklahoma can say with absolute certainty. But I recall the debate 10 years ago when many said 6 months will never be enough. Six months has done very well by the industry, as it turned out.
So by striking this balance and having the sunset provision which I strongly support in this legislation--and I have from the beginning--it will allow us to review periodically how we are doing with all of this.
There is an increase in Federal spending of $50 million over 10 years as a result of the Allard amendment. I can't invoke a point of order because the impact on federal spending is outside our current budget window, but the Allard amendment comes with a $50 million pricetag to taxpayers.
I believe this program is working well. We think by adjusting the length of exclusivity from 6 months to 3 months for a limited number of drugs, we are striking the right balance. The 5-year sunset will give us a chance to assess the program again and make a judgment: How are we doing here? Are we getting more or less of what we thought we would in the process? At that time, we will make a judgment again as to how we ought to go forward.
It is not easy to strike these balances. I know my colleagues who have engaged in these debates, try to come up with answers that will satisfy the various elements and concerns various Members have. That is what Mike DeWine and I did 10 years ago and why I had such a good partner in this where we struck that balance. Mike was under a lot of pressure to have a lot more than 6 months of exclusivity. I was under pressure in saying: Why do we give them any exclusivity? So we compromised on 6 months to see what happened. We got great results.
I would love to predict with absolute certainty that what we craft here will produce those same results. I can't say that absolutely. But based on the analyses of others who have looked at this, their conclusion is this is a pretty healthy balance between consumer interests, taxpayer interests, and the needs of children. We will see what happens over the next 4 or 5 years as to whether this is continuing to produce the desired results. I believe it will. I think we will get that.
Here again, based on recent data, under my proposal, 80 percent of drugs studied under this program will see no change in the exclusivity award of 6 months. Again, for the 20 percent of drugs in the blockbuster category, they can receive 3 months of exclusivity. I still believe many will go forward, given that incentive.
So respectfully I say to my friend from Colorado--we serve on two committees together and we work well together on a lot of issues here. I respect him immensely. I do not question at all his motivations in offering this amendment. This disagreement is over the impact of his language versus the language I have crafted in this legislation as part of the committee print.
So I urge my colleagues to reject the Allard amendment and to stick what with what we put together in the underlying bill. It is a good balance between taxpayer interests, consumer interests, and the interests of children and their families.
Mr. President, I yield the floor.