In the USA, the Pediatric Research Equity Act of 2003 means that the US FDA can require sponsor pharmaceutical companies to conduct specifif pediatric clinical studies, in order that the approved product information can incorporate proper prescribing guidance for children. The implementation of this was recently tested by researchers who evaluated the characteristics and completion ratefor mandatory pediatric post-marketing studies required under the Act. The researchers examined studies required for new drugs and new indications approved by the FDA between January 1, 2007, and December 31, 2014, with follow-up to the end of November 2017. Information was obtained from publicly available FDA databases and ClinicalTrials.gov, direct communication with the FDA, and searches of MEDLINE, EMBASE, and Web of Science for peer-reviewed publications. Between 2007 and 2014, the FDA approved 114 new drugs and new indications for already approved drugs that were subject to Pediatric Research Equity Act requirements, and this was associated with 222 required pediatric postmarketing clinical studies. Overall, 75 pediatric studies (33.8%) were completed as of December 1, 2017. Efficacy studies (38 of 132 [28.8%]) were less likely to be completed than pharmacokinetic studies (19 of 34 [55.9%]). Much of the information required for proper interpretation could not be identified for 74 studies (33.3%), and no reason for discontinuation was provided for 29 of the 42 discontinued studies (69.0%). Amongst those completed , the results were reported for only 57 studies (76.0%). At the time of approval, 18 of 114 drug approvals (15.8%) had any pediatric efficacy, safety, or dosing information in their labels. After a median duration of follow-up of 6.8 years (interquartile range, 4.7-9.1 years), only 41% had any pediatric prescribing information. More timely completion of pediatric drug studies is clearly required – read more here.
Big Pharma dragging the chain on completion of pediatric studies
Nov 21, 2018