May 4, 2001

Washington, D.C. —  Senators Chris Dodd, D-Conn., and Mike DeWine, R-Ohio, today introduced legislation to extend a measure they authored four years ago that has successfully provided better labeling and testing of pharmaceuticals intended for use in children. The absence of pediatric labeling and testing poses significant risks for children -- without adequate information about how a drug works in children of different ages and sizes, children are more likely to be under- or over-dosed or to experience dangerous side effects.

“Giving your child medicine shouldn’t be like Russian Roulette, where you reach into the medicine cabinet and hope for the best,” said Dodd. “This measure will help take the guesswork of children’s medicines.”

“Our Better Pharmaceuticals for Children law has been remarkably successful,” Senator DeWine said. “Parents and doctors will no longer be left guessing at dosage, safety, and adverse event information when medicating children now that many of these medications are being tested for children. It would be unacceptable for adults to have to guess at the correct dose, any adverse interactions, and the safety and effectiveness of medications they take. Children should not be held to a lesser standard.”

The ‘Best Pharmaceuticals for Childrens’ Act, would reauthorize legislation originally enacted by Dodd and DeWine in 1997, to encourage pediatric drug research by giving drug companies an incentive of six months of additional market exclusivity to test their products for use in children. The original legislation is due to expire at the end of this year if it is not re-authorized by Congress. The new legislation will extend the measure for an additional five years, and also provide a new initiative to label older “off-patent” drugs.

Earlier this year, the FDA issued a report citing the law’s overwhelming success in generating new pediatric drug research and in getting products better labeled for kids. In the 3 years since the initiative was launched, over 300 pediatric drug studies have been undertaken, compared to the 11 studies conducted in the 6 years prior to the legislation.

Dodd and DeWine were joined at the press conference by representatives of the American Academy of Pediatrics, and the Elizabeth Glaser Pediatric AIDS Foundation. The National Association of Children’s Hospitals, and the American Society for Clinical Pharmacology and Therapeutics are also supporting the measure.

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