Introducing the FDC Act § 505(q) Citizen Petition Tracker . . . .

October 21, 2008

Last week, I presented at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes with Geoff Levitt of Wyeth on citizen petitions.  The focus of my talk was on new FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain Applications” –  which was added to the FDC Act by § 914 of the FDA Amendments Act (“FDAAA”).  A copy of my presentation is available here.

Briefly, FDC Act § 505(q) provides that FDA shall not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 or § 10.35, unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  Under the new law “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”  FDA may not extend the 180-day period “for any reason,” including consent of the petitioner.  FDC Act § 505(q) does not apply to all citizen petitions.  Excluded from the new law are petitions that relate “solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv)” (i.e., 180-day exclusivity), and petitions that are made by an ANDA or 505(b)(2) sponsor “that seeks only to have [FDA] take or refrain from taking any form of action with respect to that application.”  Petitions subject to FDC Act § 505(q) must include a specific certification identified in the new law, and petition supplements and comments must include a specific verification statement. 

As I noted during my presentation, there are several unresolved issues with the new law.  For example, how is “intent to delay” determined by FDA?  FDA’s failure to respond to a citizen petition within 180-days is not a petition denial, but rather “final agency action.”  What does this mean for challenging such “final agency action,” particularly if there is little to nothing in the administrative record from FDA? 

Notwithstanding a growing list of questions about the new law, FDA has begun to provide some guidance.  For example, FDA is reportedly interpreting FDC Act § 505(q) to apply to petitions that are submitted after an ANDA or a 505(b)(2) application is submitted to the Agency.  Why?  FDC Act § 505(q)(1)(A) refers to a “pending application.”  Because FDA will not reveal to a petitioner whether an application is pending, however, a petitioner will not know if the 180-day deadline applies – unless, of course, a generic applicant publicly states it has submitted an ANDA or a 505(b)(2) application or FDA’s ANDA Paragraph IV Certification List provides that notice.  Therefore, if a petition is submitted too soon, the 180-day FDA response deadline would not apply. 

Also, in a recent petition response concerning the approvability of a pending 505(b)(2) application, FDA notes that while FDC Act § 505(q) requires the Agency to take action on a petition within 180 days, the Agency cannot make any final decisions concerning the approvability of NDAs.  Specifically, FDA states in an October 10, 2008 petition response that:

There is no evidence that in enacting section 505(q) of the Act, Congress intended to vitiate an NDA applicant’s procedural rights by requiring that the Agency make decisions that constitute final Agency action regarding the approvability of aspects that are specific to a pending application (e.g., specific claims proposed in a drug product’s labeling) on a piecemeal basis outside of the process established under the Act and regulations.

As the number of citizen petitions subject to FDC Act § 505(q) mounts, we thought it would be useful to provide a mechanism by which to track them.  Hence, the creation of the “FDC Act § 505(q) Citizen Petition Tracker.” The Tracker is an Excel spreadsheet with links to petitions and petition decisions that will appear on the right-hand side of FDA Law Blog.  We will update it as new petitions are submitted and petition decisions are made.  According to information we were able to cull from, 28 petitions with the FDC Act § 505(q) certification have been submitted to FDA since FDAAA’s enactment.  FDA has thus far denied 11 petitions and granted/denied in part 2 petitions.  Fourteen petitions are pending and one has been withdrawn; however, one of the pending petitions concerns 180-day exclusivity (i.e., FDA-2008-P-0117; Clopidogrel Bisulfate), and FDA presumably does not consider it subject to FDC Act § 505(q).  Another petition – a petition for reconsideration submitted under 21 C.F.R. § 10.33 – was submitted after FDA denied the original petition submitted pursuant to 21 C.F.R. § 10.35, and is presumably not subject to FDC Act § 505(q).  (FDC Act § 505(q) defines a “petition” to mean a written request submitted pursuant to 21 C.F.R. § 10.30 or § 10.35.)

As of today, FDA’s track record in meeting the 180-day response deadline is encouraging.  According to available information, only one pending petition is outside the deadline – FDA-2008-P-0185 concerning Minocycline HCl (SOLODYN). We are not aware of any action yet to litigate FDA’s failure to timely respond to that petition.

By Kurt R. Karst    

Categories: Drug Development