Reports: Scrutiny of European rules to spur trials of pediatric drugs

It's well known that there's been a lack of drug development for the pediatric market. Yet reports in the Financial Times explore whether recent incentives in Europe for developers to address the dearth of pediatric drugs are too sweet.

Taking effect in 2007, the European regulations give drug companies additional marketing exclusivity for drugs in return for their investment in developing medicines for children. The regulations have brought both huge jump in the number of applications to develop pediatric drugs and criticisms from those who believe the program could sidetrack developers from investing in important treatments for adults, the Financial Times reports.

Pfizer ($PFE), which plans to introduce a chewable form of hit anti-cholesterol drug Lipitor in Europe in November, could reap an additional six months of marketing exclusivity in EU countries in return for developing the pediatric form of the drug. That additional time without competition to low-cost generic versions of the heart pill could be worth about $800 million to Pfizer, according to an FT report.

- check out the FT articles on the policy issue and Pfizer's potential coup

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