FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions: Something Old, Something New, Something Borrowed, FDA is Still Blue

September 25, 2013

By Kurt R. Karst –    

FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on the FY2011 report, and our posts here, here, and here on reports from previous years).  FDA continues to express certain concerns about the petitioning process, such as serial petitioning, and continues to say that it is monitoring “the number and nature of 505(q) petitions submitted and [analyzing] whether section 505(q) is effectively discouraging petitioners from submitting petitions primarily to delay the approval of applications.”  But FDA, in the latest report, is more emphatic than in previous reports about expressing frustration with how responding to 505(q) petitions interferes with other Agency work, particularly in light of the enactment of the FDA Safety and Innovation Act (“FDASIA”), which shortened FDA’s response deadline.  The latest report also provides updated numbers and new statistics on the petitions received by and acted on by FDA.

By way of background, FDC Act § 505(q) was added to the law by the 2007 FDA Amendments Act (“FDAAA”) and is intended to prevent the citizen petition process from being used to delay approval of pending ANDAs and 505(b)(2) applications.  The law was amended by § 301 of Pub. L. No. 110-316 (2008), and again by FDASIA § 1135, which, among other things, changed the original 180-day response deadline to 150 days, and made the law applicable to citizen petitions concerning biosimilar applications submitted to FDA pursuant to PHS Act § 351(k).  (See our FDASIA summary here.)  In June 2011, FDA issued final guidance on FDC Act § 505(q).  In January 2012, FDA proposed regulations to amend the Agency’s citizen petition regulations.  FDA is reportedly evaluating the impact of FDASIA § 1135 on both the final guidance and proposed regulations.

Under the current version of FDC Act § 505(q), which was in effect for part of FY2012, the statute says that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  Under FDC Act § 505(q), which FDA has interpreted to apply only to certain petitions submitted to the Agency after September 27, 2007 (when FDAAA was enacted), “[FDA] shall take final agency action on a petition not later than 150 days after the date on which the petition is submitted.”  FDA may not extend the 150-day period “for any reason,” including consent of the petitioner, and may summarily deny a petition submitted with the primary purpose of delaying ANDA, 505(b)(2) application, or 351(k) biosimilar approval.  FDA has never summarily denied a 505(q) petition.  Instead, FDA seems to have resorted to a form of public shaming (see our previous post here) when the Agency suspects delay tactics.

FDC Act § 505(q)(3) requires that each annual report to Congress specify: “(A) the number of applications that were approved during the preceding 12-month period; (B) the number of such applications whose effective dates were delayed by petitions referred to in paragraph (1) during such period; (C) the number of days by which such applications were so delayed; and (D) the number of such petitions that were submitted during such period.”  FDA says in its Fifth Annual Report that:

Between September 27, 2007, and September 30, 2012, FDA determined that a delay in approving an ANDA was necessary to protect the public health in the case of five 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.

During the FY 2012 reporting period, the agency approved 42 applications submitted under section 505(b)(2), 517 ANDAs, and no biosimilar biological product applications.  No approvals for any 505(b)(2) or biosimilar biological product applications were delayed because of the filing of a 505(q) petition in this reporting period.  No ANDA approvals were delayed in this reporting period because of pending 505(q) petitions.

During the FY 2012 reporting period, 24 petitions considering 505(q) petitions were submitted to the agency.  FDA did not miss the statutory deadline for responding to any 505(q) petitions during this reporting period.

FDA explained in previous reports that five ANDAs have been delayed because of pending 505(q) petitions.  That number will increase when FDA presents its Sixth Annual Report.  In an August 2013 denial of a March 2013 petition (Docket No. FDA-2013-P-0247) concerning the approval of generic Zoledronic Acid Injection, FDA noted that the petition caused a 25-day delay in ANDA approvals. 

In previous reports, FDA explained that the Agency has timely responded to all but two of the 505(q) petitions within the statutory timeframe.  Although FDA did not blow the statutory deadline in FY2012, FDA’s track record of timely responding to 505(q) petitions within the applicable statutory period will be tarnished in FY2013.  Earlier this month, FDA passed the 150-day deadline for responding to a citizen petition (Docket No. FDA-2013-P-0471) submitted by Bayer HealthCare Pharmaceuticals Inc. requesting that the Agency award 5-year new chemical entity exclusivity for the oral contraceptive NATAZIA (estradiol valerate and estradiol valerate/dienogest) Tablets (see our previous post here).

The Fifth Annual Report provides some consolidated petition numbers from FYs 2008-2012.  According to FDA, the Agency has received a total of 116 petitions subject to FDC Act § 505(q).  The annual number of petitions has remained relatively steady at around 20 petitions, with the exception of FY 2009, when there were 31 petitions:

New to the Fifth Annual Report is a table summarizing the outcomes for the 505(q) petitions – 97 of them – that were resolved as of September 30, 2012:

That means that as of the conclusion of FY2012, FDA denied about 64% of 505(q) petitions, denied in part and granted in part another 27%, and granted only 7% of the 97 petitions.  (Another almost 2% were voluntarily withdrawn by the petitioner.)

FDA has consistently expressed frustration with how responding to 505(q) petitions interferes with other Agency work.  FDA’s frustration is amplified in the Fifth Annual Report, however, now that the Agency has had experience with the 30-day haircut to the original 180-day deadline.  According to FDA:

The enactment of FDASIA has increased the agency resource requirements for responding to 505(q) petitions.  Section 1135 of FDASIA significantly shortened the time frame by 30 days and has given FDA less time to evaluate the issues, articulate its scientific and legal reasoning, and formulate a response on the issues referenced in the petition.  As a result, FDA has needed to direct resources away from other important initiatives to attempt to comply with the new shorter deadline.

Not included in the Fifth Annual Report (and not required to be) is FDA’s progress with meeting the new 270-day timeframe at FDC Act § 505(w) covering discontinuation petitions submitted pursuant to 21 C.F.R. § 314.161.  That provision was also included in FDASIA.  A quick look at our FDA Citizen Petition Tracker, however, indicates that the Agency is doing well in meeting that statutory mandate.  ANDA suitability petitions are another story altogether.  FDA has regularly failed to meet the 90-day statutory decision deadline for those petitions for years.  We’ll save that analysis for another day.  But in all fairness, we note that FDA does appear to be taking steps to address the situation.  FDA recently published new procedures that are intended to bring the Agency back into compliance.