On November 19, the House approved, by voice vote, a bill (S. 650) to require pharmaceutical manufacturers to test products for their effectiveness and safety on children. The Senate approved S. 650 on July 23. It will now go to the White House for the President’s signature.
In 1998, the Food and Drug Administration (FDA) issued the “pediatric rule,” which required manufacturers to test their drugs and biological products for use in children. On October 17, 2002, a federal district court ruled that the FDA exceeded its statutory authority when it issued the rule. Sponsored by Sen. Mike DeWine (R-OH), S. 650 would give the FDA the explicit statutory authority to implement the pediatric rule.
Rep. Deborah Pryce (R-OH) highlighted the importance of the FDA rule, noting, “Many people wrongly assume that children’s bodies are just smaller versions of adult bodies. That is just not the case. Simply reducing the dosage of medicine for the treatment of a child is not always effective and is definitely not always safe. By protecting this rule, the pediatric rule, and continuing to provide incentives for testing medicines for kids, we will give doctors the information they need to provide our children with the best quality healthcare.”
Rep. Anna Eshoo (D-CA) agreed. “The FDA’s gold standard has protected American consumers and America’s children for decades. The Congress has to take this step to equip the FDA with the resources and the authority it needs to continue this exceptional performance,” she stated.
