Senators Seek to Renew Testing Provision for Children’s Drugs
Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio) are proposing reauthorization of a law that grants an additional six months of patent protection to drug companies that test drugs meant for children on children, the Hartford Courant reports. The "extremely lucrative" "pediatric exclusivity provision" -- whose value one estimate figures to be $1 million a day "or more" -- is scheduled to expire at the end of this year. It gives eligible companies a six-month extension on product patents as part of the 1997 FDA Modernization Act. A summary of an FDA report released Monday by Dodd and DeWine said that "[t]he absence of pediatric testing and labeling poses significant risks for our children." Dodd said, "Parents shouldn't have to play Russian roulette when it comes to giving their children the right dosage of medicine" (Hathaway, Hartford Courant, 1/9).
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