Source: http://www.fdalawblog.net/2012/09/the-coming-505q-citizen-petition-cliff-and-some-interesting-petition-strategies/
Timestamp: 2018-11-17 06:19:24
Document Index: 190530663

Matched Legal Cases: ['§ 1135', '§ 1134', '§ 314', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 10', '§ 505']

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.
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:
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.