FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is Paramount

By Kurt R. Karst –      

Earlier this week, FDA announced the availability of a final 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 statutory provision added to the law by § 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. L. No. 110-85 (2007), as amended by § 301 of Pub. L. No. 110-316 (2008).  The final guidance is quite similar to the draft guidance FDA issued in January 2009 (see our previous post here), except for FDA’s discussion in the final guidance of what the Agency requires for complete certification and verification statements.

For the uninitiated, 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.  Specifically, 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), which FDA has interpreted to apply only to certain petitions submitted to the Agency after September 27, 2007 (FDAAA’s enactment date), “[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, and may summarily deny a petition submitted with the primary purpose of delaying ANDA or 505(b)(2) application approval.  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 submitted by an ANDA or 505(b)(2) applicatin sponsor that seek “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, and petition supplements and comments must include a specific verification statement.  The statements must disclose when information supporting the petition, supplement, or comment became known to certain parties and must identify the parties in interest.

FDA Law Blog vigilantly follows 505(q) petitions and we regularly update our popular FDC Act § 505(q) Citizen Petition Tracker. with new petitions and decisions.  As we reported earlier this year in a two-part post (here and here), FDA has submitted reports to Congress detailing the Agency’s experience with 505(q) citizen petitions and describing several Agency initiatives to encourage early submission of certain petitions so that the petitions can be received in time to avoid a delay in ANDA or 505(b)(2) application approval.

FDC Act § 505(q)(1)(H) says that FDA “shall not consider a petition for review unless the party submitting such petition does so in written form and the subject document is signed and contains” a certification stating:

I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me.  I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: _______________.  If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: _______________.  I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.

Similarly, FDC Act § 505(q)(1)(I) says that FDA “shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and the subject document is signed and contains” a verification stating:

I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the action requested herein first became known to me on or about _______________.  If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: __________.  I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition.

FDA’s final 505(q) citizen petition guidance document cautions petitioners to strictly adhere to the statutory certification statement:  

As part of our determination of whether a petition contains the complete 505(q) certification, we will evaluate whether (1) the language of the certification in the petition exactly mirrors the language provided in section 505(q) and (2) the petitioner provided a date on which the information first became known to the party on whose behalf the petition is submitted. Because section 505(q) sets forth the exact words to be used in the certification, we will consider a certification to be deficient if every word in the petitioner’s certification does not match every word of the certification provided in section 505(q).  In other words, the petitioner’s certification must correspond verbatim to the certification in section 505(q).  For example, if, rather than using the phrase “first became known to the party on whose behalf this petition is submitted,” the petitioner substitutes the phrase “first became known to me,” we will consider the certification to be deficient.  We believe this interpretation is mandated by the statutory language because section 505(q) specifies the exact text of the certification. [(Emphasis added)]

FDA also cautions petitioners to use specific dates:

Section 505(q) also requires that the petitioner provide in the certification the date on or about which the information first became known to the party.  Section 505(q) includes a blank space in the certification for that information.  We consider a “date” to include a month, day, and year.  Therefore, we will consider a certification to be deficient if the petitioner has not provided the month, day, and year on or about which the information first became known to the party on whose behalf the petition is submitted.  For example, if the petitioner provides “May 2010” as the date in the certification, we would consider the certification to be deficient.  The text of the certification provided in section 505(q) includes a qualification that the petitioner learned of the information “on or about the following date.”  Therefore, we believe the certification would accommodate instances in which a petitioner may not know the exact date on which it became aware of the information.  To the extent that a petitioner believes further explanation of the date is needed, we believe that the blank space in the certification allows for the insertion of additional information. In addition, there may be instances in which different types of information became known to the petitioner over a period of time.  In that case, the petitioner should provide each estimated relevant date and identify the information associated with the particular date.  We caution that when adding information, the petitioner should ensure that the words of the certification (except for what is provided in the blank space) continue to exactly match the words of the certification as provided by section 505(q).  [(Emphasis added)]

The same FDA interpretations apply to verification statements included in petition supplements and petition comments.  FDA says in the final guidance that “[a]s with our approach to the certification . . . , we will consider a verification to be deficient if it does not exactly mirror the words of the verification in section 505(q)(1)(I) of the Act or if the petitioner or commenter does not provide a month, day, and year for the ‘date’ in the verification” (emphasis added).

And while we’re on the topic of citizen petitions, we note that the U.S. District Court for the Eastern District of Pennsylvania recently issued an opinion in In Re Flonase Antitrust Litigation.  The case stems from three different lawsuits filed by various parties alleging that GlaxoSmithKline (“GSK”) violated the antitrust laws by submitting sham citizen petitions to FDA pre-FDAAA and initiating a baseless lawsuit challenging FDA’s approval of generic FLONASE (fluticasone propionate) Nasal Spray.  (As we previously reported, last year the district court denied GSK’s motion to dismiss.)  GSK moved for summary judgment, arguing that its conduct is protected from antitrust liability under the First Amendment and by the Noerr-Pennington doctrine, under which private entities are immune from antitrust liability in petitioning the government to influence the passage or enforcement of laws, even if the laws they advocate for would have anticompetitive effects.  Judge Anita B. Brody denied GSK’s motion for summary judgment, saying that “genuine issues of fact remain as to whether GSK’s conduct was objectively baseless, and thus constitutes ‘sham’ petitioning not entitled to Noerr-Pennington immunity.”