September 27, 2019
Authored and Edited by Emily R. Gabranski; Shana K. Cyr, Ph.D.
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:
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.
Readers are encouraged to read the final guidance, also available on FDA's website.
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