The FDA has released its 2013 report to Congress regarding delays caused by 505(q) petitions.  As most of you know,  a 505(q) petition was created by Food and Drug Administration Amendments Act (FDAAA) of 2007 to require certain response times to petitions submitted to the FDA that would potentially delay the approval of a 505(j) or a 505(b)(2) application.  Congress took this action because FDA response times to Citizen Petitions sometimes took years and industry complained that these delays in response caused delays in approvals for ANDA and (b)(2) applications.

FDA has done very well since the FDAAA in meeting the timeframes for response.  FDAAA placed a 180-day response deadline on the FDA to respond to these petitions.  The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) changed that response time to 150 days.  A petition is considered a 505(q) petition if it requests the Agency to change or add a requirement or approval to covered application or requests that the Agency stay the approval of an ANDA, 505(b)(2) or biosimilar application.  The FDA must meet the time limit for response unless the Agency makes a determination that the delay of approval of the pending application is necessary to protect the public health.   Now, with that background, let’s see how the FDA has performed.

“Between September 27, 2007, and September 30, 2013, FDA determined that a delay in approving an ANDA was necessary to protect the public health in the case of seven ANDAs with related 505(q) petitions. FDA has not delayed approval of any 505(b)(2) applications or biosimilar biological product applications based on 505(q) petitions.“

Over the 6-year period from 2008 through 2013, the FDA received 131 petitions subject to the provisions of Section 505(q) of the Act.  Over this 6-year period, the FDA responded to all but 6 petitions within the statutory timeframes established at the time of petition submission (those 6 petitions resulted in delay of 7 ANDAs).  During FY 2013, the FDA delayed approval of 2 ANDAs (the delay was 25 days), but no 505(b)(2) applications or biosimilar applications were delayed because of a decision on a 505(q) petition.  In FY 2013, there were 15 petitions that were classified as a 505(q) petition.

The Agency has received about 80-90 petitions a year with about 20 of them classified as 505(q) petitions requiring responses within the statutory timeframe.   This is a lot of work for the Agency and, considering the relatively short response time and some very complex issues raised in the petitions, the Agency has done a very good job in meeting its requirements. The FDA reports that “[A]s of September 30, 2013, 83 of the petitions (approximately 67 percent) responded to under section 505(q) have been denied.  Another 31 petitions (approximately 25 percent) have been denied in part and granted in part. Only eight petitions (approximately 6.5 percent) have been granted.  An additional two petitions, approximately 1.5 percent, were voluntarily withdrawn by the petitioner.

The FDA notes that “[I]t is difficult to determine whether section 505(q) is discouraging the filing of citizen petitions aimed at blocking generic competition.”  The statistical breakdown of petitions submitted over the 6 year period is provided in the table below taken from the report.  The full report can be found here.