Regulatory Focus™ > News Articles > IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed

IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed

Posted 29 February 2012 | By Alexander Gaffney, RAC 

An Institute of Medicine (IOM) report released 29 February praises the effects of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) on safe and effective medicinal practices in children, but calls for further expansion of pediatric studies.

The report, entitled Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA, was commissioned at the request of the US Food and Drug Administration (FDA), which wanted the review done before PREA and BPCA come up for renewal by the Congress this year.

The report notes that more than 400 drugs have been studied under the acts-a radical departure from when many drug companies simply recommended prescribing drugs to children off-label rather than conduct costly and difficult pediatric clinical trials.

The report recommends FDA require sponsors to conduct long-term follow-up clinical trials in children more frequently and address the lack of testing in newborns and premature infants by providing more resources.


Read more:

IOM: Federal Laws Have Enhanced Pediatric Drug Studies; IOM Report Identifies Options for Further Improvements

IOM: Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA

Nature: Childhood drug studies show room for improvement

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