Kid Tested, FDA Approved: Examining Pediatric Drug Testing
Allan M. Joseph
Hoping to increase the number of drugs tested in children, Congress and FDA have placed a set of incentives for and requirements on drug manufacturers, notably through sections 505A and 505B of the Food, Drug, and Cosmetic Act. Using publicly-available data, I demonstrate that many drugs still lack pediatric study, and that many pediatric studies provide only weak evidence. I also show that requirements have been more important than incentives in encouraging these trials. Finally, I recommend steps Congress and FDA can take to improve the evidence available to pediatric prescribers to ensure drugs are used safely and effectively in children.
Food and Drug Law Journal
Volume 72, Number 4