Did citizen petitions prolong the number of approval days of generic drugs?

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 data set containing Food and Drug Administrations (FDA) abbreviated new drug applications (ANDAs) with and without citizen petitions, and their filing and approval dates. Descriptive analyses were conducted. An independent t-test was used to analyze the difference of the numbers of approval days of the generic drugs with and without citizen petitions.

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 184 (63.7%) ANDAs during this period. More than a third (36.3%) of all ANDAs had a single petition. Among the ANDAs with the citizen petition, the average number of petitions per ANDA was approximately two. The numbers of approval days of the ANDAs with and without citizen petitions were 1221.7 and 978.6 days, respectively, and they were statistically significantly different (p-value < 0.0001).

Conclusion: The number of approval days of the generic drugs with citizen petitions was significantly higher than the number of approval days of the generic drugs without citizen petitions.