(WASHINGTON, D.C.) On Monday, the Food and Drug Administration (FDA) announced it would "suspend" a federal requirement that requires pharmaceutical companies to test their products to determine the safety and efficacy of those medicines for children.
The decision would set aside a regulation aimed at providing doctors and parents better information when giving children medications, many of which are only tested in adults.
Sen. Murray released the following statement:
"Given this administration's record, the decision to roll back yet another public safety protection is not altogether surprising; but to abandon a child safety protection is shocking.
Children often respond differently to drugs – their bodies are smaller and their organs less well developed than adults. Therefore, pediatricians need to have the information that pediatric labeling provides - including the safety, efficacy and dosage of medicines prescribed to children.
This is why the American Academy of Pediatrics, The National Association of Children's Hospitals, and many other organizations supported the rule.
In 1997, I was an early supporter and co-sponsor of the 'Best Pharmaceuticals for Children Act,' which encouraged drug manufacturers to test pediatric medicines.
Since this legislation, in tandem with the FDA rule, over 400 pediatric drug studies have been undertaken, compared to only 11 studies in the 6 years prior to the legislation. New pediatric information has been or will soon be added to the labels of 37 products, including drugs for AIDS, diabetes, mental health and asthma.
We have made progress in protecting children by making certain that the medicines prescribed to them are safe and effective. Yet thousands of parents give their children Ritalin every day, despite the fact that it has never been tested on young children.
For the Administration to abandon this measure is beyond comprehension."