So the Government Accountability Office releases a report examining the virtues of the Best Pharmaceuticals for Children Act of 2002, which authorizes the FDA to ask drugmakers to study their meds for kids. In exchange, a drugmaker gets six extra months of marketing exclusivity and, presumably, greater profit. The law is up for Congressional renewal in the fall.

Here’s what the GAO finds: Between January 2002 and December 2005, FDA made 214 requests for studies, and drugmakers agreed to conduct 173, but completed only 59. Of those, patent extensions were granted for 52. Meanwhile, 87 percent of the finished studies led to label revisions, such as adding indications for appropriate dosages and unusual side effects.

A recent JAMA study advocated that the benefits to kids outweight the monopolies given drugmakers. The authors, whose work was supported by NIH grants, conducted an economic analysis of drugs for nine common ailments and found the return on investment was all over the map, although there may be windfalls for blockbusters. They recommended renewing the law.

Clearly, the law provides valuable information. But before Congress renews, it should ask why more studies aren’t being completed sooner and whether drugmakers engage in self-serving cherrypicking by first completing studies with the potential for the greatest return.

The GAO report;
Associated Press story about GAO report;
JAMA study (subscription required).

[tags]Government Accountability Office, Pediatric Exclusivity, Pediatric Studies[/tags]