[Congressional Record Volume 143, Number 60 (Friday, May 9, 1997)]
[Senate]
[Pages S4276-S4277]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                BETTER PHARMACEUTICALS FOR CHILDREN ACT

  Mr. DODD. Mr. President, I rise here this morning to comment on a 
piece of legislation that my colleague from Ohio, Senator DeWine, and I 
introduced actually a few days ago, but because of the pressing nature 
of the business on the floor of the Senate, did not get a chance to 
actually discuss it here.
  I would like to describe what we have introduced and urge our 
colleagues to

[[Page S4277]]

join us in this effort and urge the administration to join us as well.
  The legislation we introduced is called the Better Pharmaceuticals 
for Children Act. It is a piece of legislation that we think has great 
value.
  According to the American Academy of Pediatrics, only one-fifth, or 
20 percent, of all drugs on the market in the United States have been 
tested for their safety and effectiveness in children. Children are not 
simply smaller versions of adults. Their bodies actually metabolize 
drugs quite differently as they grow older.
  The lack of information about how drugs work in children can place 
pediatricians in an untenable position. They can either prescribe 
powerful drugs for their young patients that have only been tested in 
adults or they can deny them access to life-saving therapies.
  This dilemma is dramatically illustrated in the case of children with 
AIDS. The hopes of tens of thousands of adult AIDS patients were raised 
last year by the promising benefits of protease inhibiters. However, 
the families of very young children have much less to be hopeful about.
  None of these drugs is yet approved for newborns and infants. This is 
despite the fact that the earliest days of a child's life may be the 
most promising time to reverse the effects of HIV. As unbelievable as 
it may seem, physicians are forced to treat these children without the 
benefit and guidance of research.
  Even in adults, getting the proper dosage of these powerful drugs is 
tricky indeed. Too large a dose can cause severe side effects; too 
small a dose can make the HIV virus mutate into a far more dangerous, 
drug-resistant strain. In children, the effects are compounded. A full-
strength dose can kill a toddler.
  Other examples of this problem, Mr. President, are also quite 
disturbing. Despite the fact that asthma is one of the most common 
chronic illnesses in children, and the most common cause of children's 
admissions to hospitals all across this country, there is only one 
asthma drug that has been tested for children under 5 years of age.
  In fact, my colleague from Ohio personally and eloquently related a 
situation with one of his own children who has asthma that I am sure he 
will comment on at some appropriate time. It is alarming that with 
asthma we have the single most common reason for admission to the 
hospital for children and yet we have no drugs tested to treat children 
under the age of 5.

  As other examples, despite the fact that sedatives are used to help 
treat sick and injured children, not a single sedative has been 
specifically tested for safety and efficacy in children under the age 
of 2. In addition, virtually every medication currently used to treat 
stomach and intestinal diseases in children has only been tested in 
adults.
  While this so-called off label prescribing is neither illegal or 
improper, it forces doctors to practice hand-me-down medicine for 
pediatric cases, which is unacceptable, to put it mildly.
  I think it is about time, Mr. President, we took the guesswork out of 
children's medicine. The Better Pharmaceuticals for Children's Act is a 
simple solution to this problem. It provides a fair and reasonable 
market incentive for drug companies to make the extra effort needed to 
test their products for use by children. It grants an additional 6 
months of market exclusivity for drugs which have undergone pediatric 
studies at the request of the Secretary of Health and Human Services.
  I want to briefly point to something most parents are all too 
familiar with--the disclaimers that appear on the labels of so many of 
the pharmaceutical products that are needed and used by children: ``Not 
recommended for use in children, as no clinical studies have been 
performed to determine risks, benefits, and dosages.'' Another says, 
``Safety and effectiveness in children younger than the age of 2 has 
not been established.'' Or, ``Safety and effectiveness in children 
younger than age 12 have not been established.'' And, ``Safety and 
efficacy in children younger than age 18 have not been established.''
  We have labels on the food that children eat; we have labels now for 
the programs that children watch on television. I think we would all 
agree that it is about time we have labels that parents and physicians 
can rely on when they give children medicine.
  The bill that Senator DeWine and I have introduced is a sensible way 
to keep our children healthier. That is why it has enjoyed broad 
bipartisan support both in and outside of the Congress.
  In fact, the bill is endorsed by the American Academy of Pediatrics, 
the Pediatric AIDS Foundation, the National Association of Children's 
Hospitals, and PHRMA, the trade association of the pharmaceutical 
industry. Senators Mikulski and Kennedy have signed on as cosponsors, 
and I know that Representative Greenwood will soon be introducing this 
bill in the other body.
  Mr. President, this is commonsense legislation. I call on our 
colleagues to join Senator DeWine and myself in this effort. We hope we 
can get passage quickly. I urge my colleagues to support this bill.

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