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government announced plans Monday to begin clinical tests this year on
12 drugs commonly prescribed for children even though their safety and
effectiveness has been tested only in adults.
"Children often react differently to drugs than adults do," said
Health and Human Services (
news -
web sites) Secretary Tommy Thompson. "We need to conduct testing now
to fully understand the effects of these medications in children."
The 12 drugs include azithromycin, an antibiotic that's used to treat
different types of bacterial infections, and baclofen, a muscle relaxant
used to relieve muscle problems caused by multiple sclerosis or spinal
injuries.
Dr. Jane M. Orient, executive director of the Association of
Physicians and Surgeons, questioned whether most of the drugs on the
list should not be tested in children because of potential risks.
"Safety testing needs to be done, but adults should bear the risks,"
she said. "Once in use, it would seem that careful aftermarket
surveillance of any usage in children, as medically indicated and under
the supervision of a personal physician, would be greatly preferable to
clinical trials."
The National Institute of Child Health and Human Development
developed the list of drugs to be tested in consultation with the Food
and Drug Administration (
news -
web sites) and experts in pediatric research. It will be updated
annually.
The FDA issued regulations in 1998 requiring drug companies to test
adult medicines commonly given to children. A federal judge threw out
the rule last year, saying Congress never intended to give the agency
the power to require such tests.
Congress enacted legislation last year giving drug makers financial
incentives for conducting the tests. It also set up a grant program to
provide federal dollars for pediatric studies that manufacturers won't
do, despite the incentives.
Thompson said tests on the 12 drugs listed Monday will be the first
sponsored by the government under that new law. The National Institutes
of Health (
news -
web sites), which will oversee the tests, has set aside $25 million
from its current budget, and the FDA, which will review the test
results, has set aside $6.6 million.
Thompson said President Bush (
news -
web sites)'s budget request for the fiscal year that begins in
October will include another $61.5 million for the testing program.
He said the administration also will ask Congress this year to
clearly establish FDA's authority to require drug manufacturers to
conduct pediatric clinical trials on new drugs. Legislation requiring
such trials was introduced in the Senate last year by Sens. Mike DeWine,
R-Ohio, Hillary Rodham Clinton (
news -
web sites), D-N.Y., and Chris Dodd, D-Conn.
The 12 drugs listed Monday are no longer under patent. Officials said
the tests, which will take about two years for each drug, will be done
by private contractors under the supervision of NIH. The contractors
have not been selected.
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