FDA Releases Annual Report on Citizen Petitions, Stays of Agency Actions

August 22, 2016

The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year.

The report shows the total number of petitions dropped from 102 in 2014 to 74 in 2015. When it comes to citizen petitions, none were granted fully — for the second straight year — and just two were granted in part, which is the lowest since 2012. Just three petitions from last year were not responded to within the agency’s 150-day deadline.

In its conclusion the agency states that it continues to be concerned that the guidelines for citizen petitions are not discouraging the submission of petitions that are simply filed to delay the approval of a competing drug or medical product, which is reflected in the high number of rejections.

The FDA added that the tight deadline, combined with the fact that the majority of submissions are intended to delay introduction of products from competing companies, has often come at the expense of completing other work within the agency.

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