FDA to refer citizen petitions attempting to delay generics to FTC

Home/Guidelines | Posted 26/10/2018 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 2 October 2018 that it had released new draft guidance designed to limit the use of citizen petitions to delay approval of generics and biosimilars. The new guidance informs brand-name drugmakers how the agency would highlight any improper use of these petitions in its annual reports filed with Congress. It also highlights FDA’s intention to refer petitions that it judges as an attempt to delay competition to the Federal Trade Commission (FTC).


The draft guideline on citizen petitions was published in a Federal Register announcement on 3 October 2018. The draft guideline is intended to provide information regarding FDA’s current thinking on implementing section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(q)) concerning certain citizen petitions and petitions for a stay of agency action related to a pending application.

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Date: October 2018

The draft guidance revises the guidance for industry entitled ‘Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act’ issued in November 2014.

The draft guidance describes how FDA determines if:

  1. The provisions of section 505(q) of the FD&C Act addressing the treatment of citizen petitions and petitions for stay of agency action apply to a particular petition.
  2. A petition would delay approval of a pending abbreviated new drug application (ANDA), 505(b)(2) application, or 351(k) application.

FDA says that ‘one area of focus has been shutting down practices used by branded firms to “game” the system and take advantage of certain rules, or exploit loopholes, to delay generic approval – thereby extending a drug’s monopoly beyond what Congress intended’. One way of doing this, according to the agency, is the use of Citizen Petitions. The revised draft guidance therefore seeks to lessen the impact that FDA review of petitions may have on any pending approvals.

By implementing the guideline, FDA intends to dissuade companies from using petitions to improperly delay the approval of generics or biosimilars.

The agency also issued a Final Rule, which became effective on 9 January 2017, requiring that all citizens petitions or stays of action should include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known [1]. This was to prevent petitions being submitted late in the review process in a deliberate attempt to delay competition.

Related article
Delaying generics using citizen petitions

1. GaBI Online - Generics and Biosimilars Initiative. FDA amends citizen petition rules to reduce delays to generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Policies-Legislation/FDA-amends-citizen-petition-rules-to-reduce-delays-to-generics-and-biosimilars

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Federal Register, US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010