The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies

By Kurt R. Karst –      

As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations on the recent changes to the law and some interesting strategies we have heard about.

FDC Act § 505(q), which was added to the law with the enactment of the 2007 FDA Amendments Act, provides that FDA shall not delay approval of a pending 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.”  Until July 9, 2012, FDC Act § 505(q) applied in the context of a pending ANDA or 505(b)(2) application and stated that “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”  With the enactment of the FDA Safety and Innovation Act (“FDASIA”), however, the 180-day timeframe was reduced to 150 days.  In addition, FDASIA § 1135 amended FDC Act § 505(q) to apply not only to citizen petitions concerning pending ANDAs and 505(b)(2) applications, but also to citizen petitions concerning biosimilar applications submitted to FDA pursuant to PHS Act § 351(k).  FDA may not extend the pre-FDASIA 180-day period or post-FDASIA 150-day period “for any reason,” including consent of the petitioner, and the Agency may summarily deny a petition submitted with the primary purpose of delaying approval of an application.  Petitions subject to FDC Act § 505(q) must include a specific certification, and petition supplements and comments must include a specific verification statement.  The certification and verification statements must disclose when information supporting the petition, supplement, or comment became known to certain parties and must identify the parties in interest.

FDASIA § 1135 (along with another petition provision at FDASIA § 1134 that sets a 270-day deadline for FDA to respond so-called discontinuation petitions submitted pursuant to 21 C.F.R. § 314.161) appears to be intended to realize greater savings from generic drug and biosimilar approvals as a result of quicker FDA decisions on citizen petitions.  As we’ve noted elsewhere, however, FDC Act § 505(q) petition decisions often are not keyed to generic drug and biosimilar approval decisions.  As such, it seems more likely that with a 150-day response timeframe, FDA will issue more non-response petition denials.  That is, decisions FDA issues by the statutory deadline, but that do not substantively address the issues raised in the 505(q) petition.  We may find out soon whether or not this will be the case, as FDA appears to be headed for a 505(q) petition cliff.

Over the years, we have vigilantly followed 505(q) petitions with our FDC Act § 505(q) Citizen Petition Tracker.  According to our data, between May 18, 2012 and July 17, 2012, there were 13 505(q) citizen petitions submitted to FDA.  Five of the petitions were submitted after the enactment of FDASIA.  The confluence of the pre-FDASIA 180-day response timeframe applicable to 8 of the 13 petitions and the post-FDASIA 150-day response timeframe applicable to 5 of the 13 petitions means that responses to all of the 13 petitions are due between November 14 and December 15, 2012.  FDA has its work cut out for it indeed! 

FDC Act § 505(q) is intended to prevent the citizen petition process from being used to delay approval of ANDAs and 505(b)(2) applications (and now PHS Act 351(k) applications for biosimilars).  This appears to have worked.  According to FDA’s third annual report to Congress on 505(q) citizen petitions, “[o]ver the three year period during which we have been reviewing 505(q) petitions, the number of applications that have been delayed due to analysis of the issues raised in the 505(q) petitions is low: 4 ANDAs and no 505(b)(2) applications.”  FDC Act § 505(q) also appears to have spawned new strategies, however, to obtain competitive intelligence. 

A citizen petition is considered a 505(q) petition requiring the certification at FDC Act § 505(q)(1)(H) if, at the time of FDA’s receipt of the petition, a pending ANDA, 505(b)(2) application, or 351(k) application is implicated.  In many cases, it is already known that an application is pending at FDA.  For example, a company may have submitted notice of a Paragraph IV certification to a patent listed in the Orange Book to the NDA holder or patent owner.  In some cases, however, it is not known whether there is an application pending at FDA, because, for example, there are no patents listed in the Orange Book that would give rise to a Paragraph IV certification, or there is an Orange Book listed patent, but it is a method-of-use patent subject to a section viii carve-out statement. 

In an effort to obtain competitive intelligence about the status of an application as pending at FDA, we’ve heard about a couple of strategies – serial petitioning and petitioning without a 505(q) certification.  In the case of serial petitioning, a company may petition FDA and wait out the 150-day response timeframe for a response from FDA.  If that response is an interim response issued pursuant to 21 C.F.R. § 10.30(e)(2) and says something like “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials,” then it seems clear that at the time the petition was received by FDA a pending application was not implicated.  The petitioner may then submit a new petition raising the same or similar issues in an attempt to find out whether or not anything has changed since the submission of the last petition. 

A company may also submit a petition without a 505(q) certification in an attempt to elicit a quick FDA response.  FDA’s final guidance on 505(q) petitions states the following with respect the FDC Act § 505(q)(1)(H) certification requirement:

If a petitioner has submitted a petition that is missing the required certification but is otherwise within the scope of section 505(q) and the petitioner would like FDA to review the petition, the petitioner should (1) submit a letter withdrawing the deficient petition pursuant to § 10.30(g) and (2) submit a new petition that contains the certification.  In this case, the provisions of section 505(q) governing the treatment of petitions will apply only to the new petition that includes the required certification because we cannot review the deficient petition under section 505(q)(1)(H).  In particular, we consider the 180-day timeframe for FDA to respond to the petition to begin from the date of submission of the new, complete petition and not the original, deficient petition.

Because FDA will not review a petition that is subject to section 505(q) but is missing the required certification, all petitioners raising issues that could delay the approval of a possible ANDA or 505(b)(2) application should include the certification in their petitions to ensure FDA consideration. Although we may contact a petitioner to notify him or her of a missing or deficient certification, we note that it is the responsibility of the petitioner to ensure that its petition complies with the applicable requirements of section 505(q), as well as all other applicable statutory and regulatory requirements.

Based on our docket monitoring, it seems that FDA has, in fact, in the past contacted the petitioner if the 505(q) certification is deficient or missing – and usually pretty soon after a petition is received by the Agency.  If that is true, then it raises the possibility of submitting a petition to FDA without the certification and waiting for FDA to ask that the petition be resubmitted with the certification.  And why would FDA ask?  Because there is a pending application that would be affected by the petition.