You probably assume the medicines you give your children have been tested for kids. That's been the case since 1998 when the pediatric rule went into effect, but now a decision by the Food and Drug Administration may change that. The FDA says it will suspend the pediatric rule for two years.
Some drug companies that have fought drug testing for children are calling it a victory, while others worry that decision may be a hard pill for children to swallow.
Angie Watson of Frohna says, "It doesn't sound like a good idea. I don't see how it could be helpful for anybody, it seems like they're asking for trouble." The Food and Drug Administration is facing that problem head-on by not testing drugs children use. Many opponents say a decision to suspend that rule could cause more harm than good, while supporters claim it's actually helping less and hurting more.
Sam Kazman of the Competitive Enterprise Institute says, "When FDA demands additional testing, even for as sensitive a population as children, it's adding additional hurdles to actually making those therapies available, which means it's denying patients access to new treatments."
But pediatric testing requires test subjects, and drug companies aren't eager to face cases like Gage Stevens. Gage died in after taking part in a study of the heartburn drug Propulsid. His mother Gretchen says, "Don't ever put your child in study even if they say it's gonna be monitored closely."
Without pediatric studies, prescribing medicine for children will now be a guessing game for doctors, trying to figure out which drugs are safe for children and the proper dosage. A risk some moms, like Amy Cook, are scared to take. "I don't think it's right," Cook says. "They should test drugs for children because they're people too and they need to be as safe as we are. If they do it for adults why not for children. They're our future."
Even though the FDA has decided to suspend the rule, doesn't mean it's gone forever. It's still in the books for them to look over and study.