[Congressional Record Volume 143, Number 60 (Friday, May 9, 1997)]
[Senate]
[Pages S4281-S4282]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                BETTER PHARMACEUTICALS FOR CHILDREN ACT

  Mr. DeWINE. Mr. President, I turn at this point to a matter that was 
brought up a little while ago by my distinguished colleague from 
Connecticut, Senator Chris Dodd. He spoke very eloquently about the 
piece of legislation that he and I are introducing, a piece of 
legislation that we believe will dramatically improve health care 
available to America's children.
  We as a nation need to do a better job making sure our children get 
the pharmaceuticals that are appropriate for them. This is a matter I 
have been concerned about for some time, and it is a matter that as the 
father of eight children is near and dear to my heart.
  We are introducing the Better Pharmaceuticals for Children Act. This 
legislation will provide an incentive in the form of 6 months of market 
exclusivity to encourage pharmaceutical companies to conduct the 
necessary clinical trials for FDA approval of their products for 
children. These studies would take away the guesswork that too many 
physicians and parents go through in trying to treat their sick 
children. These studies would do away with this guesswork by giving an 
incentive to the drug companies, by giving them a 6-months extension on 
their patent exclusivity so as to give them the incentive to do the 
trials and do the studies that would give parents and give physicians 
better information.
  This is not a new product. Let me give several examples to show my 
colleagues what the problem is. The first example goes back to 1960. 
There was a drug called chloramphenicol that was approved for use in 
adults to control bacterial infections. This drug was widely used with 
adults and it was successful, but when it was used on children the 
results were devastating. It shut down their liver. Many children got 
sick and, tragically, a number of them died. This came to be known as 
the gray baby syndrome.
  Let me give another example of the problem that our bill attempts to 
address. There was a little 4-year old leukemia patient named Stewart 
Baxter who had to scream through a spinal tap, had to go through 
immense pain because the doctors were advised they could not give him 
an anesthetic. The anesthetic was thought to be harmful to young 
patients. However, later they found that was not true. A few weeks 
later he was allowed to undergo the same procedure--this time, however, 
under the anesthetic. Better information earlier would have prevented 
that child's agony and would have made it possible for the parents not 
to have had to undergo that trauma as well in watching their child go 
through that pain.
  Let me give you another example. Dr. Ralph Kaufman, representing the 
American Academy of Pediatrics, testified in the House of 
Representatives about a 1-month-old infant that he treated. He was 
treating it for a life-threatening infection, the kind of infection 
that was resistant to all available antibiotics except one. That one 
antibiotic was not labeled for children. They had not done the testing. 
And it certainly was not labeled for a 1-month-old infant. But Dr. 
Kaufman took the chance, combining his knowledge with the physiology of 
the 1-month-old child with how the instructions said the antibiotic 
should be used for adults. In this case Dr. Kaufman said the gamble 
paid off. But sometimes the outcome is not so favorable. Physicians 
have to gamble, due to a lack of information. Sometimes physicians do 
not take the chance and they lose the availability of a very useful 
drug. Other times they do take the

[[Page S4282]]

chance and maybe the results are not what they had expected. By passing 
this bill, we will change that. As a result, children can be treated 
for diseases with greater safety and with greater confidence.

  The problem this bill addresses is a very serious one. About 80 
percent of the drugs on the market today have not been approved by the 
FDA for use in at least one pediatric age group--80 percent. As a 
consequence, the drugs do not carry labeling information explaining how 
they should be taken by children. This is because clinical trials are 
expensive. It is a dollars-and-cents issue, and often there is little 
market incentive for pharmaceutical companies to conduct these tests. 
The result is that drugs are usually prescribed for children on the 
basis of adult trials and the pediatrician's own experience. Children 
are not just small adults, and therefore this is a somewhat risky 
business. Physicians deserve better information and children deserve, 
as well as their parents, better information.
  I had experience in my own family. Senator Dodd alluded to this a 
moment ago. He just heard me talk about it. When you have children, you 
have a lot of medical experiences. But a number of years ago, my 
daughter Becky, who was very young, had developed asthma. As is the 
experience, sadly, of many parents who have children with asthma, we 
ended up spending many evenings and sometimes the middle of the night 
in emergency rooms when Becky would have an attack.
  Finally, the physician who was treating Becky said: Look, we need to 
do something about this. I don't think we should allow this to 
continue. There is something that is on the market today. We have 
information about its use by adults. I think we should go ahead and try 
it and I think we should see if it will work with Becky.
  He prescribed to her an inhaler that looks similar to the one that I 
am carrying right now, and gave it to Becky. She was able to use that. 
I was able to help her, and it lessened the trips to the emergency room 
for asthma attacks. She was able to get through childhood without 
anymore serious, horrible trauma, going to the emergency rooms because 
of asthma attacks.
  So I think this is an experience that many people have had. It is 
important, I think, to make the change in the law to give the drug 
companies the incentive so they can go out and do these tests. There 
are many drugs that are in this category, including those used to treat 
AIDS, as well as, as I mentioned, those to ease asthma attacks, drugs 
to alleviate pain, drugs even to treat other illnesses. Too often, 
physicians and parents are forced to guess about dosages or possible 
side effects. They should not have to play this kind of Russian 
roulette with their sick children.
  This problem has been around for a long time. In the last session of 
Congress this bill was passed by the Labor Committee, but unfortunately 
it did not reach the floor.
  We have had extensive discussions with the Food and Drug 
Administration, pediatric community, pharmaceutical companies, and 
makers of generic drugs. I am confident that we have come up with a 
practical way to remedy this problem. This bill is supported by health 
providers, including the American Academy of Pediatrics, the National 
Association of Children's Hospitals, and the Pediatric AIDS Foundation.
  I intend and hope to work with the FDA to solve this problem and find 
the best approaches, both legislatively as well as administratively. I 
look forward to continuing our dialog with the FDA. But I am not going 
to and Senator Dodd is not going to wait around for a proposal that 
they might make. This is our proposal. It is a legislative proposal. I 
believe it will do the job. I look forward to moving this bill through 
the Senate.
  Mr. President, we all want to see better labeling for drugs used to 
treat our sick children. Today, I believe, with this bill, we are 
taking the first step to resolve a very serious national health 
problem. Senator Dodd and I are serious about seeing this legislation 
pass both Houses of Congress this session. This project is a very high 
priority and we will do all we can to make it happen. I encourage my 
colleagues to cosponsor the legislation and encourage their help and 
assistance when the bill reaches the floor.

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