Efforts to Improve Research on Kids' Drugs Paying Off:
WEDNESDAY, Feb. 29 (HealthDay News) -- Federal laws requiring
medical companies to conduct pediatric drug studies have helped
provide guidance on whether it's safe or effective for children to
use certain medications, a new U.S. report finds.
The Institute of Medicine (IOM) report noted, however, that
there's still not enough data on the use of drugs in newborns or
the long-term effects of drugs on kids generally. The IOM, part of
the National Academies, is an independent, nonprofit organization
that provides advice to U.S. policymakers, health professionals,
industry and the public.
Congress has attempted to increase the number of pediatric
studies of medications with the passage of two laws: the Best
Pharmaceuticals for Children Act, which offers companies financial
incentives to conduct the studies; and the Pediatric Research
Equity Act, which requires pediatric studies in specific
In reviewing these laws, which are due for reauthorization this
year, the IOM committee found that both laws have had a positive
effect on the use of drugs in children. The committee noted,
however, that the laws could be more effective if the U.S. Food and
Drug Administration used its authority to require that drug makers
undertake long-term follow-up studies after products have been
approved for sale.
Long-term studies are especially important for young patients
because children's bodies and minds are not fully developed and
they could be taking medications for chronic conditions over the
course of many years, the report stated. The IOM committee added
that newborns are also more vulnerable to the side effects of
The report, released Feb. 29, concluded that Congress and the
FDA could step in to improve research in these areas and force drug
manufacturers to conduct timely long-term studies on the risk of
medications among children or face penalties. This may be
necessary, the report authors suggested in a news release from the
National Academy of Sciences, because conducting research on
children is more difficult and often yields less lucrative results
than studies involving adults.
The Nemours Foundation has more about
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