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.