Political Quotes

“I rise today to support S. 838, the Best Pharmaceuticals for Children Act. In the January 2001 report to Congress, the FDA stated that the law that we are reauthorizing today, "has done more to generate clinical studies and useful prescribing information for the pediatric population than other regulatory or legislative process to date." In just the 3 years since the law was implemented, it has made a positive difference in the lives of thousands of children. I am pleased to be a cosponsor and strong supporter of this highly successful program. In the short time that this program has been in existence, FDA has issued about 200 written requests for pediatric studies. Companies have undertaken over 400 pediatric studies, of which 58 studies have been completed, in a wide range of critical therapeutic areas, including gastro esophageal reflux disease, diabetes mellitus, pain, asthma, and hypertension. Thirty-seven drugs have been granted pediatric exclusivity, and important label changes have either been made, or are underway, as a result of pediatric studies.”