[Congressional Record (Bound Edition), Volume 147 (2001), Part 7]
[Senate]
[Page 9180]
[From the U.S. Government Publishing Office, www.gpo.gov]



                          VITAL DRUG SHORTAGE

  Mr. DeWINE. Mr. President, I rise today to discuss an emergency 
situation facing many of our hospitals across the country. It is an 
emergency that faces our hospitals, many of our doctors but, much more 
importantly, it is an emergency that faces the tiniest members of our 
society, and they are babies who are about to be born and premature 
babies.
  Right now, we have a drastically short supply of a vital drug that is 
used to help save the lives of babies who are born prematurely. Let me 
explain.
  There is a drug called beta-methasone, commonly known as Celestone, 
which is given to mothers who are about to deliver their child early. 
The drug is designed to help the premature baby's lungs develop more 
fully and more completely and to help reduce the risk of bleeding in 
the baby's brain.
  This drug is absolutely essential to giving these tiny newborns a 
chance to live and grow into healthy children.
  An obstetrician at Riverside Hospital in Columbus, Dr. Tracy Cook, 
contacted me about the current shortage of this very necessary drug. 
From what I understand, many hospitals no longer have a supply of the 
drug on hand at all, and others have only a few day's worth left in 
stock. In fact, I have taken a survey around Ohio, and I suspect what I 
found in Ohio is true across the country, that doctors and hospitals 
are running low, many are out, some will be out in just a few days.
  I have contacted the Secretary of HHS, Mr. Tommy Thompson, as well as 
the FDA, to enlist their help in getting emergency supplies of the drug 
shipped to hospitals as soon as possible. The FDA tells us there are 
some manufacturing problems with the drug which is causing this 
shortage.
  Whatever the delay, I believe it is absolutely critical that we get 
these drugs to our hospitals so that no lives are lost, no matter what 
the cause is for this delay. This is a problem which has to be dealt 
with.
  This drug is critical to the health and future of premature babies. I 
urge my colleagues to support me in urging the FDA to take whatever 
action is necessary to resolve this problem. The lives of so many 
newborns hang in the balance.
  This is a problem the FDA must address immediately. We have contacted 
the FDA, and the response we get back is: These are manufacturing 
problems. That does not tell us what the exact problem is, nor does it 
tell us what the FDA is doing and what the manufacturer is doing to 
resolve this problem.
  We need some answers from the FDA. This is something that cannot wait 
2 weeks or 1 month or 6 months. This problem has to be resolved over 
the next few days. It is critical for the safety of these newborn 
children.
  I thank the Chair. I yield the floor.

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