Pediatric program helps spur new drug research

Over the past 10 years a government program aimed at spurring clinical trials into the pediatric applications of existing therapies has helped foster more than 300 new studies leading to 115 new labeling indications. But the incentive for those studies--an extra six months of patent protection--has also spurred debate about the added profits that drug companies can reap through the research. A new study of the Pediatric Exclusivity Program by researchers at the Duke Clinical Research Institute found that some companies gained windfall profits from the patent extension while others made little or nothing. Of the 59 therapies granted exclusivity between 2002 and 2004, one in five was a blockbuster, with more than a billion dollars in annual revenue.

Changing the incentive to three months, they concluded, would actually do more harm than good. Drug companies needed the added incentive to warrant the additional research expense, and three months of extra patent protection was unlikely to trigger nearly as many new trials as the existing program does.

- check out the article from Forbes