[Congressional Record Volume 147, Number 141 (Thursday, October 18, 2001)]
[Senate]
[Pages S10826-S10829]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 BEST PHARMACEUTICALS FOR CHILDREN ACT

  Mr. DODD. Mr. President, earlier today this body passed, by unanimous 
vote, the Best Pharmaceuticals for Children Act. This is a bill I 
authored a number of years ago with my good friend from Ohio, Senator 
Mike DeWine. He is presently occupied at a Judiciary Committee hearing, 
and he will come to the floor and offer his own statement. I ask 
unanimous consent that whatever time he seeks, the Chair would provide 
him with an opportunity to be heard on this bill.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DODD. Mr. President, I thank my friend from Ohio. He has been a 
great partner in numerous efforts we have made together on behalf of 
children. S. 838 is something for which both of us are tremendously 
proud, the Best Pharmaceuticals for Children Act.
  Let me briefly describe the bill, why it is a bit different than the 
bill we passed 3 years ago, and why it is important.
  This bill would reauthorize the pediatric testing incentive 
legislation we passed in 1997 as part of the Food and Drug 
Administration Modernization Act. This important program has gone a 
long way toward ensuring that doctors and parents have the most up-to-
date and critical information on medications for our children. It has 
been an important achievement.
  According to the American Academy of Pediatrics, about 20 percent--I 
think a little less--of the drugs on the market have been tested and 
labeled specifically for their safety and effectiveness for children. 
Children are simply not smaller versions of adults, as I hope most 
people are aware.
  The bodies of infants, toddlers, and adolescents are very different 
and react very differently to drugs than adults do. The absence of 
pediatric labeling poses some very significant risks for children. 
Without adequate information about how a drug works in children of 
different ages and sizes, they are more likely to be either underdosed 
or overdosed or to experience dangerous side effects.
  Mr. President, again, years ago--in fact, in fairly recent history--
there were a lot of products out there for adults and children, but for 
many years there were just the basics, and parents, over the years, 
would take the old family aspirin and the children's dosage was to cut 
it into quarters or halves and take it. It was pretty safe. Nobody 
suffered terribly. Trying to calculate a child's dosage of traditional 
medicines in times past was not that difficult. There were some 
hazards. But we have seen a wonderful explosion of new products.
  I note the Senator from New Jersey is presiding. Both in his State 
and mine, we have literally thousands of constituents who have 
dedicated their lives to the research and development of products to 
make us all healthier, live better lives, and live longer.
  In the process, however, only about 20 percent, as I mentioned--a 
little less--have actually been tested and designed to serve children's 
needs. Despite the fact that children represent in excess of one-
quarter of the population of this country--25 percent--only a tiny 
fraction of the products on the shelves to be prescribed by doctors are 
actually labeled and designed to meet their needs. It seems sort of 
staggering to me that we have waited so long to do this. We have labels 
on the food that children can eat. We now have labels on the music to 
which they listen. We have labels that will tell you what movies you 
ought not to let your child go to. But when it comes to pharmaceutical 
products, we have very little of that.
  With that as a background, Senator DeWine and I, in 1997, as part of 
the Food and Drug Administration modernization bill, crafted this 
legislation as a way to see if we could not induce --there was a debate 
on whether we should mandate it and say you have to do it whether you 
like it or not, which is one approach, or should we say we will give 
you a chance to prove to us you can do it by providing 6 months of 
exclusivity in the marketplace. There was a debate about that.
  I had my own doubts about whether or not this was going to work very 
well. I must say the success of this legislation has been beyond 
anyone's wildest imagination. If I can, I will share some of the 
comments made about the success of the 1997 act, which would go out of 
existence, by the way.
  Why did we need to pass this legislation, and why am I so 
appreciative of

[[Page S10827]]

the Members who helped make this happen? It didn't happen just with 
Senator DeWine and I. A lot of people were involved, and I am grateful 
to them all.
  The bill would have gone out of existence; it expires at the end of 
December. The period of exclusivity would be over and the question of 
whether or not we would be able to see the continued development of 
children's products in the area of pharmaceuticals would become less 
attractive.
  Look at some of the comments. This is from the Food and Drug 
Administration status report to Congress in January of this year:

       The pediatric exclusivity provision has done more to 
     generate clinical studies and is more useful in 
     prescribing information for the pediatric population than 
     any other regulatory or legislative process to date.

  That is a pretty remarkable statement. I am grateful for that. 
Further down here, this is from the National Association of Children's 
Hospitals:

       This is a remarkable achievement for children's health. We 
     know from talking with pediatric researchers at children's 
     hospitals across the country that the effect of the pediatric 
     exclusivity provision has been very positive for children and 
     their families and their providers of care.

  Further down is a letter from the American Academy of Pediatrics. 
These are the pediatricians across the country:

       We cannot overstate how important this legislation has been 
     in advancing children's therapeutics. It is allowing children 
     to have the same kind of drug safety and efficacy information 
     that was only available previously to adults.

  There is also a letter from the Elizabeth Glaser Pediatric AIDS 
Foundation:

       Regarding costs, the FDA estimates that consumer prices of 
     drugs have increased by one-half of one percent annually as a 
     result of the initiatives of pediatric testing. As 
     individuals who have fought for decades for better health 
     care for children, we firmly believe this is a legitimate 
     price to pay to ensure our children's well-being.

  I don't know of anybody who will argue with that when you consider 
the difference we can make in children's lives. If I can, let me share 
with my colleagues more specifically what has happened. In light of the 
extraordinary times we find ourselves in today, the national debate on 
how to prepare and protect all Americans from bioterrorism further 
highlights the importance of drug safety and the efficacy of 
information when it comes to treating children. Children are especially 
vulnerable to the release of chemical or biological toxins. As we 
identify antibiotics or vaccines to prevent or treat illnesses related 
to bioterrorism, we are going to need to know the proper dosing 
information, possible side effects or risks of this kind of medicine, 
and the effectiveness of the various agents children would be 
ingesting. Any antidotes used for children will be affecting them at 
critical periods of childhood growth and development. We need to have 
proper medications to prevent or reduce those risks.
  This bill could help ensure that essential treatments for exposure to 
hazardous materials are studied. I will work with the FDA and my 
colleagues, Senators Clinton of New York, Kennedy, and Frist. In fact, 
I thank Senator Frist and Senator Clinton for their contribution to 
this effort today. Our hope is that we will get it done in conference 
and strengthen some language to require that the industry start 
developing children's vaccines and antibiotics in the area of 
bioterrorism.
  So this bill is a timely piece of legislation. I am confident the 
House will act. I urge them to do so quickly, to incorporate some of 
the changes that we think can make a difference in terms of children's 
health.
  I will say what was going on before we passed this bill. In the 3 
years, 36 months, since we passed this legislation--prior to the 
passage of this bill, there had been a total in the previous 7 years of 
11 clinical trials for products designed for children. I think there 
may have been 2 or 3 products that had come on the market designed 
specifically for children in 6 or 7 years. In the 36 months, since the 
bill that Senator DeWine and I wrote, there have been 400 clinical 
trials. In 36 months, there have been 400 clinical trials as opposed to 
11 in the previous 7 years in children's pharmaceutical products. 
Today, there are 40 new products in 36 months being prescribed for 
children. They did not exist 36 months ago.
  It occurs specifically because of the legislation we adopted--this 
body and the other body--in 1997. That bill was about to go out of 
existence. The bill we passed today--and every Member ought to take 
pride in it because every Member allowed this bill to go forward. Many, 
such as my friend from North Dakota, Senator Conrad, are cosponsors. I 
will leave the record open for others who would like to be associated 
with it.
  In the midst of all of these terrible events going on--this body is 
working today, by the way, and we did excellent work today, this body 
passed a bill that will make a difference in people's lives. So we are 
not just meeting for the sake of meeting to have a good show, but 
actually we adopted this legislation by unanimous consent. It would not 
have occurred without the cooperation of Democrats and Republicans--the 
100 Members in this body who allowed this legislation to go forward.
  In 36 months, there have been 400 clinical trials and almost 40 new 
products on the shelves. That is the record of this little bill 
attached to the FDA Modernization Act.
  Let me talk about one product and make this case more clearly. I am 
talking about a product that, as a result of pediatric studies, would 
make any parent's heart skip a beat; it is called Versed. Versed is one 
of the most commonly used sedatives for children undergoing surgery or 
other hospital procedures.
  As a result of these pediatric studies, the label has been changed to 
indicate a higher risk of serious life-threatening situations in 
children with congenital heart disease and pulmonary hypertension who 
need lower doses than predicted to prevent respiratory compromise.
  Can you imagine doctors using Versed without knowing that 
information? Until we got these studies underway, it was unknown. But 
as a result of 36 months of effort, this product today is being used in 
a way that is saving lives and making a difference. Maybe it does not 
get banner headlines and it will not lead the news tonight, but it is 
something that will make a difference in the lives of children and 
their parents who care about their health.
  I heard from a doctor from Children's Mercy Hospital about a 6-year-
old boy, Darryl, who required metal pins to be inserted in his leg 
after his femur was broken in a bicycling accident. Darryl was 
prescribed Versed to relieve his anxiety and discomfort when the 
doctors and nurses each day cleaned the wounds resulting from his 
injury. This new information on Versed allowed health care providers to 
treat this young man safely and effectively with this drug.
  The second chart is before and after effects of our legislation. It 
is in small print. I will try to describe it.
  We get the products, indications, what labeling was prior to the 
adoption of this bill 36 months ago, and what has occurred afterwards. 
I will run down from everything dealing with diabetes, hepatitis, 
hypertension, juvenile arthritis, seizures, and the like. This is just 
a partial list to give my colleagues some idea of the drugs to treat 
hepatitis B, hypertension, diabetes, juvenile rheumatoid arthritis, and 
epilepsy, just to name a few. They previously had labels that simply 
read:

       Safety and effectiveness in children not established.

  That was the guideline a doctor or parent had in these areas.
  Now we have dosing information, safety information, and the 
information on adverse side effects. In fact, in one drug study for 
epilepsy, Neurontin was found to be most effective in higher doses for 
children under 5 years of age. I heard from Dr. Philip Walson at 
Children's Hospital Medical Center in Ohio who told me:

       Some children with previously uncontrolled seizures now are 
     controlled with higher doses of this drug than [what] would 
     have been used [prior to pediatric testing] if adult doses 
     were just ``scaled down.''

  In this case, instead of breaking off the aspirin and getting a 
smaller dose, as a result of the studies, we learned Neurontin, which 
is a seizure controlling medication--people who have had strokes know 
about Neurontin--for children makes a difference. Increasing the dosage 
actually made a difference.
  Far more significant than the number of studies and drugs tested are 
the stories of kids who can be helped by

[[Page S10828]]

this increased information. This past June I met with a group of five 
young children from my State of Connecticut; they were suffering from 
juvenile diabetes. In fact, almost every office had a visit from kids 
from their State suffering with juvenile diabetes.

  One young man who came to my office was from Bethel, CT, 12-year-old 
Jason Baron. I put his picture up. I am giving him TV time. He was so 
eloquent and remarkable. He could run for the Senate. He is a 
wonderful, eloquent person with juvenile diabetes. He just blew me 
away. We got to talking. He aspires--and I see my friend from 
Tennessee, and he will appreciate this--as he told me, without missing 
a syllable--and I may--that he intends to be a pediatric 
endocrinologist at 12 years of age. That is his life goal as a young 
man with juvenile diabetes.
  I was amazed and impressed at the maturity and sense of 
responsibility of this young man who is managing his disease and 
educating others, as he was doing on Capitol Hill and as he does at 
school. Part of his civic activity is to teach about juvenile diabetes.
  One of the drugs studied and labeled as a result of the bill we 
passed 3 years ago is Lantus. It is a new and recombinant form of 
insulin for type I diabetes which requires only once-a-day 
administration and results in less allergic reactions. This drug, and 
others similar to it, could help children such as Jason improve the 
quality of their lives by introducing more flexibility into their 
treatment regimes.
  While tremendous progress has been made, still more needs to be done, 
obviously, to make sure children are not an afterthought when it comes 
to pharmaceutical research. Hundreds of drugs are on the market today 
that are used in children but still have not been tested for pediatric 
needs.
  We reauthorized earlier this morning the pediatric testing incentive, 
and the explosion of research it has promised, which was set to expire 
on January 1, 2002. I am very grateful to my colleagues for the 
bipartisan support we received.
  I mentioned the presence of Senator Frist. I mentioned his name once 
before, and I will mention it again. He was tremendously helpful 3 
years ago when we originally wrote the bill and then when we watched 
the success of this legislation, which I already described. We inserted 
some language to encourage the industry to develop the vaccines and 
antibodies in the bioterrorism field. Senator Frist is working with the 
administration and others of us to develop more comprehensive 
legislation dealing with bioterrorism. We thought this bill was an 
attractive vehicle to put on something dealing with this issue.
  I thank Senator Kennedy, the chairman of the committee, for his 
terrific work, Senator Frist who I mentioned already, Senator Wellstone 
of Minnesota, Senator Hatch who has been tremendously helpful, Senator 
Clinton, Senator Reid, Senator Jeffords, Senator Bond was involved; 
Senator Corzine, the Presiding Officer, I know cares about this as 
well, and Senator Bingaman for their important contributions. I thank 
Senator Conrad and Senator Domenici who were helpful today in moving 
this bill along. I thank Senator Durbin who offered some good 
suggestions on the legislation as well, and I thank him for those 
thoughts.
  If I am leaving someone out, I apologize. I will add the names 
accordingly at the appropriate time. I also thank Deborah Barrett of my 
office, who has been a tireless staff person working with the staff of 
Mike DeWine, with Senator Clinton, Senator Frist, and so many others, 
to iron out some of the disagreements we were wrestling with on this 
legislation.

  Lastly, let me tell you some of the improvements we made in the bill.
  We ensure that the new safety information for pediatric studies is 
promptly added to drug labels.
  We require that the Food and Drug Administration quickly disseminate 
information gathered from pediatric studies to pediatricians and 
parents.
  We authorize Federal dollars to study older off-patent drugs which 
are not eligible for the existing pediatric testing incentive through a 
new off-patent fund and creating a mechanism for private contributions 
from manufacturers to support the study of off-patent drugs through an 
existing NIH foundation.
  We request frequent and thorough evaluations of the program so we can 
monitor our effectiveness in getting the needed drugs studied and, 
importantly, to have a sense of which needed drugs are not being 
studied despite FDA requests.
  In fact, to ensure that vital drugs are not being left unstudied, the 
bill includes a mechanism to ensure that if a company declines to study 
an on-patent drug that is a continuing benefit to children, the 
Secretary will make public the names of those must-study drugs that 
have not been picked up and refer them to the NIH foundation for 
funding. As a backstop, these drugs can also be referred to the off-
patent fund.
  The bill creates a new Office of Pediatric Therapeutics at the Food 
and Drug Administration to coordinate activities related to children. 
It authorizes the existing Pediatric Oncology Subcommittee to provide 
recommendations and guidance so children with cancer can have timely 
access to promising new therapies.
  Finally, because the bill will lead to increased participation of 
children in clinical trials--I mentioned 400 already in the last 36 
months--we have requested a study of the appropriateness and adequacy 
of current Federal research protections for children in clinical 
trials. I will continue to work with Senator DeWine and my colleagues 
to ensure the strongest protections are in place for this vulnerable 
part of our population.
  We have relied generously on the expertise and counsel of Elaine 
Holland Vining of the American Academy of Pediatrics; Mike Isaac and 
Natasha Bilimoria of the Elizabeth Glaser Pediatric AIDS Foundation, 
who worked tirelessly on behalf of children; Helen Rhee with Senator 
Frist; David Dorsey, David Nexon, and Paul Kim with Senator Kennedy 
deserve tremendous thanks for their work in negotiating and working out 
the fine details of this bill.
  I again thank our colleagues for their contribution today. I see the 
distinguished majority whip in the Chamber. I know the media may report 
nothing much happened today. Well, maybe it did not get a lot of 
debate, but we passed this children's bill. And I see my friend from 
Maine, Senator Collins, and I want to thank her as well for her help on 
this bill.
  The distinguished majority leader has arrived. I say to the majority 
leader, this bill did not generate huge debate. We did it unanimously. 
This bill has already made a huge difference in the lives of millions 
of children: 400 clinical trials in 36 months as opposed to 11 in the 
previous 7 years.
  So we think we have done something worthwhile today, in the midst of 
other news, which will not likely generate a headline. The Senate put 
it on the agenda and did a good job.
  Mr. REID. Will the Senator yield?
  Mr. DODD. I will be happy to yield.
  Mr. REID. This is another notch in the long line of things the 
Senator from Connecticut has done for children. Whether it was child 
care, dealing with the emotional health of children, it is one of many 
things the Senator from Connecticut has done. I guess this is kind of a 
celebration of his being a new father. So we congratulate him.
  Mr. DODD. I will show pictures, if you like.
  The PRESIDING OFFICER. The majority leader.
  Mr. DASCHLE. Mr. President, I join with my colleague from Nevada in 
expressing my heartfelt congratulations to the Senator from Connecticut 
and to others on the committee for their swift action on this bill. 
This is one of the highlights of the week. I do not know that there 
could be anything more important than providing good quality health 
care in all of its iterations to children. That is what this 
legislation does, and only because of the leadership of Senator Dodd. I 
commend him. There may be a connection between fatherhood and 
legislative production on children, but whatever the motivation, as the 
Senator from Nevada has said, no one has put more time and effort and 
leadership into the issues affecting children than has Senator Dodd. So 
it is a good way to end the week. It is another reason that staying in 
today was important, and we are grateful to him, grateful to the 
Members of the committee, Republican and Democrat, for the work done. I 
thank him.

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  Mr. DODD. I thank the majority leader.
  The PRESIDING OFFICER. The majority leader.

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