Pediatric Exclusivity: Is It Worth It?

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A study in this week’s Journal of the American Medical Association says, on balance, yes.

A group of researchers performed an economic analysis of 9 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. “This benefit should not be comprised,” they write (subscription required).

One point to keep in mind: five of the 10 researchers have subsantial ties to every big drugmaker, collectively, including research grants, stock holdings and consulting income. It’s laudable they disclosed this info. But hypothetically, they may benefit if incentives for additional studies are maintained, yes? Or no?

[tags]JAMA, Pediatric Exclusivity[/tags]

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