A U.S. program to make drugs safer for children is up for renewal

Read the full article from the Economist (February 7, 2007).

The U.S. government's Pediatric Exclusivity Program extends patent protection for drugs when the patent holder carries out further studies to determine appropriate dosage for children. According to this article:

It seems to have worked. More than 300 studies have been carried out under the programme's auspices, and 115 products have had their instructions for use changed so that doctors can prescribe them to children with reasonable confidence. Nevertheless, the scheme, which is up for renewal, and will be debated in Congress next month, is being questioned. Some observers think it is too generous, and that the patent extension should be shortened or tailored in some way.

The article goes on to cite a study published in the Journal of the American Medical Association by Jennifer Li, of Duke University. The article confirms that companies have benefited from the patent extensions in a number of examples, and indeed suggests that the benefits have far exceeded the cost of the studies.

Comment: By all means, safe my tax payer dollars rather than using them to inflate the profit margin of pharmaceutical companies. However, don't throw out the baby with the bath water; keep up the pressure to do the research needed to adjust dosages of important medications for pediatric use. Indeed, it would be better to keep a system that works but not perfectly rather than to break it in an attempt to save a few dollars. Put the effort into making the military and other budgets more reasonable! JAD