FDA Issues Draft Guidance Document Interpreting FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain Applications”

By Kurt R. Karst -     

FDA has issued a draft guidance document, titled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act," explaining the Agency's interpretation of this new statutory provision.  FDC Act § 505(q) was added to the FDC Act by § 914 of the FDA Amendments Act ("FDAAA").  FDA's guidance document affirms some of the aspects of FDC act § 505(q) on which we previously reported.  The most recent version of our "FDC Act § 505(q) Citizen Petition Tracker," which tracks such petitions, is now available (and is updated on a regular basis).

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 (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), "[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.

FDA's new guidance document describes the Agency's interpretation of FDC Act § 505(q) on how FDA determines if FDC Act § 505(q) applies to a particular petition, and whether such a petition would delay approval of a pending ANDA or 505(b)(2) application.  In addition, the guidance describes how FDA interprets the certification and verification statement provisions, and "addresses the relationship between the review of petitions and pending ANDAs and 505(b)(2) applications for which the Agency has not yet made a decision on approvability."  Some important aspects of FDA's draft guidance are highlighted below.

*       FDC Act § 505(q) does not apply to pre-FDAAA petitions – i.e., those petitions that were submitted to FDA before September 27, 2007 – "because section 505(q) does not state that it applies retroactively to petitions submitted before the effective date."

*       Communications "regarding a citizen petition should be filed as comments in the appropriate docket, not to the NDA, ANDA, or 505(b)(2) application."

*       FDA interprets FDC Act § 505(q) "to apply only to petitions for which, at the time the petition is submitted, at least one ANDA or 505(b)(2) application related to the subject matter of the petition is pending.  If there is no related ANDA or 505(b)(2) application pending at the time that the petition is submitted, then we will not consider the provisions of section 505(q) to apply to the petition."  FDA encourages "all petitioners challenging the approvability of a possible ANDA or 505(b)(2) application to include the certification required in section 505(q)(1)(H)."

*       FDA interprets FDC Act § 505(q) "to apply only to petitions that request an action that could delay approval of a  pending ANDA or 505(b)(2) application.  If the action requested by the petition could not delay  approval of the application under any reasonable theory, we will not consider the provisions of section 505(q) to apply to the petition."

*       Under FDC Act § 505(q)(1)(E), FDA may summarily deny a petition submitted with the primary purpose of delaying approval of an application and does not on its face raise valid scientific or regulatory issues.  According to FDA, "[i]f we do not find that the petition may be summarily denied, we will determine if the petition would be the cause of a delay in an approval of an ANDA or 505(b)(2) application by using a but for test.  In other words, would the ANDA or 505(b)(2) application be ready for approval but for the issues raised by the petition?  If, regardless of the petition, the ANDA or 505(b)(2) application would not be ready  for approval, then section  505(q)(1)(A) would not be implicated.  If the ANDA or 505(b)(2) application would be ready for approval but for the petition, then we would next determine if a delay of approval is necessary to protect the public health."

*       Under FDC Act § 505(q)(1)(A), FDA "shall not" delay ANDA or 505(b)(2) application approval because of a petition unless the Agency determines that a delay is necessary to protect the public health.  According to FDA, "[w]e determine if a delay of approval is necessary to protect the public health based on our preliminary evaluation of the issues raised in the petition. The Agency considers the following: If the application were approved before the Agency completed the substantive review of the issues in the petition and, after further review, the Agency concluded that the petitioner's arguments against approval were meritorious, could the presence on the market of drug products that did not meet the requirements for approval negatively affect the public health?  If, after undertaking this analysis, we conclude that the public health could be negatively  affected, the Agency will conclude that a delay "is necessary to protect the public health" and will delay approval of the pending application."  Issues identified by FDA that could implicate the public health include bioequivalence and labeling "carve-out" issues.

*       With respect to the certification requirement, FDA states that "if a petition is missing the complete certification, we will not permit a petitioner to cure the deficiency by submitting a supplement to  add the certification to the petition.  Instead, "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."  Of particular note, FDA states that "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."

*       "The review of applications that may be affected by the petition is governed by a separate review process, which will not necessarily be completed by the date the petition response is due.  If a petition requests that the Agency take an action related to a specific aspect of a pending application, we will consider the review status of the affected application(s) in determining whether it would be appropriate for the Agency to respond to the request to take the action requested in the petition within the 180-day timeframe."

*       "[R]esponses to citizen petitions, including petitions subject to section 505(q), constitute final Agency action and are subject to immediate review by the courts. They therefore carry with them none of the procedural rights for the affected applicants that attach to a decision to deny approval of an application.  If we were to respond substantively a petitioner's request regarding the approvability of a certain aspect of a pending application before we have taken a final action on the approvability of the application as a whole, such response could interfere with  the statutory and regulatory scheme governing the review of applications and related procedural  rights of applicants."  Examples of such "certain aspects" include the acceptability of a proposed trade name and specific claims proposed in a drug product's labeling.  FDA further notes that "[i]n such a situation, we would expect to deny a petition without comment on the substantive approval issue."  Indeed, this is precisely what FDA has done on several recent FDC Act § 505(q) petition (non-) responses.