OBJECTIVES: To compare the numbers of approval days of the generic drugs with and without citizen petitions.

METHODS: Data from a previous study were obtained to create a working data set containing Food and Drug Administration (FDA)’s abbreviated new drug applications (ANDAs) with and without citizen petitions, and their filing and approval dates. Descriptive analyses were conducted. Independent t-test was used to analyze the difference of the numbers of approval days of the generic drugs with and without citizen petitions at a significance level of 0.05.

RESULTS: A total of 289 ANDAs of 81 drugs submitted between the first quarter of 2008 and the third quarter of 2014 were included. Citizen petitions were submitted for 244 ANDAs or 84.4% of all ANDAs during this period. Almost a half (48.0%) of all ANDAs had a single petition, while a total of 12 (4.9%) ANDAs had 11 citizen petitions. The average number of citizen petitions per ANDA was approximately two. The numbers of approval days of the ANDAs with and without citizen petitions were 1,183.3 and 862.7 days, respectively, and they were statistically significantly different (P value <0.0001).

CONCLUSIONS: The number of approval days of the generic drugs with citizen petitions was significantly longer than those of the generic drugs without citizen petitions. The FDA must develop a strategy that can curb the impact of multiple citizen petitions on generic drugs.