Pediatric drugs get labeling changes

NEWS IN BRIEF — Posted April 16, 2007

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A majority of the drugs -- about 87% -- that have been granted exclusivity under the Best Pharmaceuticals for Children Act have had important labeling changes as a result of the drug studies conducted under the law, according to a Government Accountability Office report.

The report, released March 22, also found that drug sponsors had agreed to 173 of the 214 requests for pediatric studies made by the Food and Drug Administration.

The BPCA, enacted in 2002, allows the manufacturers of drugs that are still on patent to conduct pediatric studies. If they do so, the FDA could extend their right to market the drug without generic competition for six additional months.

The GAO report also found that the label change process was lengthy, taking from 238 to 1,055 days for information to be reviewed and changes to be approved for 18 drugs, or about 40% of those referred as of December 2005. Label changes took more than a year for seven of the drugs.

Note: This item originally appeared at

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