Pediatric drug bill introduced

Pharmaceutical Representative

The Children's Research Protection Act, a bill that would ensure safety standards for children participating in clinical drug trials, was introduced in the Senate by Sens. Chris Dodd (D-CT) and Mike DeWine (R-OH).

The Children's Research Protection Act, a bill that would ensure safety standards for children participating in clinical drug trials, was introduced in the Senate by Sens. Chris Dodd (D-CT) and Mike DeWine (R-OH).

The act would require the Secretary of Health and Human Services to review, update and strengthen current regulations governing pediatric research. All HHS-funded and -regulated research would then have to comply with the enhanced guidelines. In addition, federal agencies with no special guidelines for children's research would have to develop them within a year.

"This measure prescribes a strong dose of safety for our children," said Dodd. "It provides critically important safeguards and protections when it comes to testing pediatric medicine, ultimately increasing our knowledge of children's medication while keeping children in clinical trials as safe as possible."

According to the senators, children are an especially vulnerable population of research subjects and need additional safeguards. Potential risks such as the effect of an experimental treatment on rapidly developing organs must be critical considerations in pediatric research.

Said DeWine, "It is just common sense that we provide the strongest federal guidelines to ensure the safety of these young people, as they will ensure that drugs will be safe and appropriate for use in all children."

The legislation would provide an update to current regulations that are out of date. Of the 17 federal agencies conducting research with human subjects, only two have special guidelines for research on children. In addition, researchers who are federally regulated but privately funded are not compelled to follow the guidelines.

The legislation will also provide fellowships for pediatric pharmacology training. Only 20 physicians complete drug research specialty programs each year. Of these, only two or fewer specialize in pediatric pharmacology.

An estimated 18,000 children will be needed in the next few years to complete research that has been undertaken since the 1997 Better Pharmaceuticals for Children Act, which offers incentives to drug companies to test their products for use in children. PR