On September 18, 2019, FDA issued final guidance entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” This is the second revision of the guidance of the same name, which was originally issued in June 2011, and previously revised in November 2014. The draft version of this revised guidance issued in October 2018. In this 2019 guidance, FDA provides information concerning the scope of petitions subject to section 505(q) and considerations for determining that a petition “was submitted with the primary purpose of delaying the approval of an application.”

The new guidance reflects a change in FDA’s interpretation of section 505(q) and the petitions that are subject to its provisions. Specifically, under the 2019 guidance FDA interprets section 505(q) as applying only to petitions that (1) are submitted to FDA on or after September 27, 2007 (for petitions related to approval of an ANDA or 505(b)(2) application), or July 9, 2012 (for aBLAs); (2) are submitted in writing and pursuant to 21 CFR 10.30 (for citizen petitions) or 10.35 (for stay petitions); (3) relate to a pending ANDA, 505(b)(2), or aBLA, and the applicant’s user fee goal date is on or before the 150-day deadline for final FDA action on the petition; (4) requests action that could delay approval of the application; and (5) does not fall within an exception under section 505(q)(4).

Also new in the 2019 guidance, FDA provides multiple considerations for identifying petitions submitted with the primary purpose of delaying approval of an application, including, for example:

  • Timing. Submission of a petition after an unreasonable length of time from when the petitioner learned (or reasonably should have learned) of information in the petition, or submission of a petition close in time to the expiration of marketing exclusivity or a relevant patent.
  • Number of Petitions. Submission of multiple and/or serial petitions, or submission of a petition that raises issues previously addressed by FDA in response to a prior petition.
  • Support for Petition. Submission of a petition with little or no data or information to support its scientific positions.
  • Subject of Petition. Submission of a petition concerning standards for approval of a drug product for which FDA has provided an opportunity for public input and the petitioner has not provided comment other than through the petition, or submission of a petition requesting that other applicants be required to meet more rigorous testing, data, or labeling standards than the standards FDA has determined are necessary for the applicable listed drug and/or petitioner’s version of the same product.
  • Previous Conduct. Submission by a petitioner with a history of submitting petitions determined to have primary purpose of delay.

If FDA determines that a petition is submitted with the primary purpose of delaying the approval of an application, it intends to refer the matter to the Federal Trade Commission as potentially anti-competitive, and to highlight the determination in FDA’s annual report to Congress.