Pediatric drugs: lack of incentives for research in off-patent products

The problems surrounding pediatric cold and cough remedies for young children in the USA (see page 14) have highlighted another and wider issue relating to pediatric drugs, the lack of evidence generated by clinical testing for products for which patents have expired. The Baltimore Sun reported on this topic, uncovering the extent to which physicians essentially rely on guesswork or anecdotal evidence from colleagues to determine the suitability of certain drugs and the correct dosage for off-label uses. The newspaper recently quoted a study in the March issue of the Archives of Pediatrics & Adolescent Medicine which found that, in 2004, off-label prescribing was used in nearly 80% of cases at several children's hospitals.

Kate Michael, a spokesperson for the Pharmaceutical Research & Manufacturers of America (PhRMA) told the Marketletter that the Best Pharmaceutical for Children Act of 2002, which was recently reauthorized by the US Congress (Marketletter October 1), provides six months of additional market exclusivity for drugmakers who have conducted pediatric-use testing for patented products. However, she noted that "a similar initiative does not exist for companies to engage in pediatric research for products that are no longer covered by patents or existing marketing exclusivity."

NIH off-patent pediatric research program "not as successful as hoped"