FDA is finalizing its 2012 Proposed Rule and amending the regulations relative to certain Citizen Petitions.  While the revisions mostly pertain to section 505(q) Petitions (originally created under the Food and Drug Administration Amendments Act of 2007 [FDAAA]), the Agency is (in at least one instance) broadening the mandatory certification requirements for certain Petitions.  The Rule also amends the regulations to conform to the statutory requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

The Final Rule adds 21 CFR 10.31, which includes the following provisions (emphasis added):

  • 31(a) states that § 10.31 will encompass all Citizen Petitions and PSAs that request that the Agency take any action that could, if taken, delay approval of an ANDA, a 505(b)(2) application, or a 351(k) application (i.e., Petitions and PSAs that are or may be subject to section 505(q) of the FD&C Act).
  • Section 10.31(b) clarifies the date of submission for Petitions submitted under § 10.31.

Section 10.31(c) and (d) codify the certification and verification requirements of section 505(q)(1)(H) and (I) of the FD&C Act. Section 10.31(c) clarifies that the Agency will consider a certification deficient if every word in the petitioner’s certification does not match every word of the certification provided in section 505(q)(1)(H) of the FD&C Act.  Likewise, § 10.31(d) clarifies that the Agency will consider the verification deficient if every word in the petitioner’s or commenter’s verification does not match every word of the verification provided in section 505(q)(1)(I) of the FD&C Act.  As discussed in section II.B.4 of the preamble to the proposed rule, we are making one minor editorial change to the language of the verification set out in the statute.  We are changing “I verify under penalty of perjury that the foregoing is true and correct as of the date of this petition” to “I verify under penalty of perjury that the foregoing is true and correct as of the date of this document” (emphasis added).  Because the statute specifies the word “petition”, we will accept either “petition” or “document” in the last sentence of the verification.  In addition, section 505(q) of the FD&C Act requires both the certification and verification to be signed and executed under penalty of perjury.  FDA interprets the signature provision to require a handwritten or electronic signature by the person whose name appears as the signatory to the Petition, supplement, or comment.  If the certification or verification is signed by another person with the notation “for,” signature/[initials], “on behalf of,” or with similar notation that indicates one person signed for another, we will consider the certification or verification to be deficient and will not consider the petition for review.

So the one word that may differ is the word “document” from the word “petition” in a specific sentence in the certification; this is thought to be because comments to Petitions are not Petitions themselves, and there may be additional information submitted in support of a Petition that is not the Petition itself.

In addition, it is important to note that the provisions requiring a specific certification now will apply to all Petitions that request an action that could possibly delay the approval of an ANDA, 505(b)(2) application, or a 351k application, whether or not an application has been submitted to the Agency.  Previously, a 505(q) certification was required only when such an application was pending at the time of the submission of the Petition.  Since FDA typically does not disclose if an ANDA, 505(b)(2), or 351k application had been submitted to the Agency, or if any such application is pending at FDA, if an applicant sent in a Petition requesting an action that could delay approval of any of the three types of applications discussed above, without the 505(q) certification, the petitioner could wait to see if the FDA mandated the certification to find out if an application was pending at the Agency.

There are other minor modifications of various other section of 21 CFR 10 relative to Petitions, such as changing the 180-day response time under FDAAA to the revised 150-day response time now required under FDASIA.  The FDA also answered a number of comments submitted by PhRMA.  These additional changes and the comment and FDA’s response to the comment can be found here.  This Final Rule clearly demonstrates that every word counts –most of the time!