Pharma Blog Watch
Pediatric
Exclusivity Trials (Pharmalot)
In his blog, Ed Silverman discusses a study in The Journal of the American
Medical Association on the cost-effectiveness of pediatric exclusivity studies.
"A group of researchers performed an economic analysis of nine drugs and
found the return on investment associated with the pediatric studies was all
over the map. Not surprisingly, those six extra months of patent protection
may provide a windfall for blockbuster drugs. But they also concluded that the
program provides a useful public health benefit, because meds with skimpy profit
margins may not be studied otherwise.
"And so they conclude that reducing the patent protection to three months isn't worth it. In other words, drugmakers may stop running studies for certain drugs that kids really need, such as some antibiotics."