Understanding Pediatric Drug Lag Time: Review of Selected Drug Package Inserts

The wait for a pharmaceutical drug to become approved by the FDA for pediatrics lasts approximately 8 years longer than that for adults. One of the reasons given is the concern that simultaneous pediatric and adult trials may affect licensing in adults. We reviewed drug package inserts obtained from the FDA database for 5 selected agents for the years prior to and after being FDA approved for pediatric use. There were no new contraindications, warnings, or adverse events identified during pediatric clinical trials that would have put adult licensure at risk if approval was obtained in parallel for pediatric populations. The few changes in the package inserts in those years were due to ongoing adult clinical trials and post-marking experience in adults. The concern that pediatric trials might affect adult licensure does not appear to be justifiable.

Do Free Trade Agreements Matter to Drug Lag? Recent Evidence From Korea After the Korea–U.S. Free Trade Agreement

The KORUS FTA includes various clauses on marketing approval of new medicines and their reimbursement decisions. We aim to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate the effect of the KORUS FTA on the timely availability of new medicines in the Korean market. We selected new drug applications approved in the United States between 2007 and 2015, calculated the drug lag, which was defined as the time difference between the date of regulatory approval in the United States and in Korea, and constructed a logistic and Cox model to capture the effect of the variables of interest on the availability and drug lag of new medicines in the Korean market. The FDA in the United States approved 160 NDAs between 2007 and 2015. The KORUS FTA does not increase the availability of new medicines or shorten the drug lag of new medicines. However, the presence of the manufacturer in Korea was significantly related to the availability and drug lag in the Korean market. It is noteworthy that the presence of the manufacturer, which is a kind of by-product of free trade in pharmaceuticals, affected drug lag.

Availability and drug lag of new medicines in South Korea

Introduction This study aims to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate various factors affecting timely availability of new medicines in Korean market. Methods We construct two models for the analysis; logistic and Cox model. First, we provide the logistic regression to analyze the availability of new medicines in Korean market. Second, we are interested in the timely availability of new medicines in Korea. Therefore, we calculated the drug lag between the United States and South Korea, and applied an event history model for a statistical estimation. Results There have been 160 NDAs approved by the FDA in the United States between 2007 and 2015. Among 160 new drugs approved in the United States during the study period, 112 NDAs (70%) were also approved by the MFDS in Korea, while 48 new drugs (30%) are not currently available in the Korean market. In addition, we are interested in the order of timing for market approval for 112 NDAs that approved in both countries. Not surprisingly, 95 NDAs (85%) were approved in the United States, and then approved in Korea, while 17 NDAs (15%) were approved in Korea, and then approved in the United States. Conclusions Compared to the United States, a striking drug lag was observed in Korea. For the new drugs approved between 2007 and 2015, the median approval lag ranged from 1.72 years in 2013 to 5.84 years in 2007. Presence of the manufacturers in Korea and medicines belonging to the antineoplastic agents were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea compared to the reference. Key messages Compared to the United States, a striking drug lag was observed in Korea. Presence of the manufacturers in Korea were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea.