New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful

By Kurt R. Karst –      

A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating.  The paper, which is co-authored by Michael Carrier, a professor at the Rutgers School of Law-Camden, and Daryl Wander (currently a Law Clerk to the Hon. Francine Axelrad, P.J.A.D. of the Superior Court of New Jersey, Appellate Division) and that will be published in the Cardozo Law Review, also concludes that FDC Act § 505(q), which was added to the law by Section 914 of the FDA Amendments Act of 2007 (“FDAAA”), Pub. L. No. 110-85 (2007), as amended by § 301 of Pub. L. No. 110-316 (2008), and that is intended to prevent the citizen petition process from being used to delay approval of ANDAs and 505(b)(2) applications, “has not been successful in reducing the number of petitions.”  (Under FDC Act § 505(q), “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”  As we previously reported (here and here), pending legislation would shave 30 days off of FDA’s response timeframe, from 180 days to 150 days.)

The authors culled information from Regulations.gov on citizen petitions submitted to FDA between 2001 and 2010 concerning human drugs (excluding citizen petitions that are suitability petitions) and cross-referenced their results with the FDA Law Blog 505(q) Citizen Petition Tracker for post-FDAAA petitions containing a 505(q) certification to come up with a universe of 258 petitions for the analysis.  The authors classified FDA petition responses (177 of them) as “granted,” “denied,” or “mixed.”  For those petition decisions (51 one of them) in which FDA issued a “mixed” decision (i.e., granted in part and denied in part), the authors analyzed each response and determined that the petition was either essentially granted (24%), essentially denied (45%), or was truly a mixed decision (31%). 

Using the universe of citizen petitions and FDA petition decisions, Carrier and Wander then drilled down on the data and performed several broad and sub-group analyses.  For example, their analysis shows (Table 1 below) an increase in the average number of petition submissions pre- and post-FDAAA from 27 to 34 in the three years before and after enactment of FDC Act § 505(q), respectively.

These data comport with data FDA reported on in the Agency’s Annual Reports On Delays In Approvals Of Applications Related To Citizen Petitions And Petitions For Stay Of Agency Action (see our previous posts here, here, and here).  We are eagerly awaiting the release of FDA’s fourth annual report on FDC Act § 505(q) petitions later this year.

In terms of citizen petition success rate, Carrier and Wander looked at the number of petitions decision FDA granted and denied between 2001 and 2010 (161 of them, which does not include 16 mixed decisions and 81 petitions for which a response was not located) and found, as depicted in Figure 1 below, that FDA granted 19% (31 petitions) and denied 81% (130 petitions).  (FDA is currently in the process of clearing the backlog of old petitions that may no longer be timely – see here.)  The success rate for petitions submitted by or on behalf of brand companies (which submit 68% of petitions) is 19%, compared to a success rate of 28% for petitions submitted by or on behalf of generic companies. 

Among other things, Carrier and Wander conclude that FDC Act § 505(q) “has not been successful in reducing the number of citizen petitions.”  This conclusion seems to jibe with a concern that FDA expressed in the Agency’s third annual report on 505(q) petitions that the provision “may not be discouraging the submission of petitions that do not raise valid scientific issues and are intended primarily to delay the approval of competitive drug products.” 

By our count, FDA has already received 17 petitions in Fiscal Year 2012 containing a 505(q) certification – several in recent months.  But it is too early to tell whether or not the Fiscal Year 2012 numbers will be on par with the numbers from previous years.  FDA may ultimately determine that not all of the petitions meet the criteria for consideration as a 505(q) petition.  For petitions submitted to FDA in Fiscal Year 2012, the Agency has issued three responses (two denials and one mixed decision).  A couple of the petitions are “duplicates” insofar as the petitions were withdrawn and resubmitted (and assigned a different docket number).