Efforts to Improve Research on Kids’ Drugs Paying Off: Report

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 situations.

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 medications.

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.

More information

The Nemours Foundation has more about understanding medications.

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