FDA issues final guidance on petitions delaying generics

INICIO/Directrices | Posted 08/11/2019 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 18 September 2019 that it had issued final guidance to address ‘gaming’ by the use of citizen petitions.

ANDA Approval V13F21

According to FDA Acting Commissioner, Ned Sharpless, the agency has been concerned about anticompetitive tactics involving companies submitting certain types of citizen petitions in order to delay FDA action on a generic drug or other abbreviated application. Although he adds that ‘the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process’. This guidance has therefore been issued to address these concerns and is part of the FDA’s Drug Competition Action Plan.

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Date: September 2019
www.fda.gov/media/130878/download

An amendment to the Federal Food, Drug, and Cosmetic Act petition regulations, Section 505(q), was signed into law in 2016 to prevent citizen petitions and petitions for stays of action from purposely delaying drug approvals. The section requires the agency to make a final decision within 150 days on petitions containing any requests that could delay a pending generic drug’s approval.

This final guidance replaces the draft guidance that was released in October 2018 [1]. It aims to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions. The approach would help FDA allocate resources efficiently when addressing petitions that are most likely to present an obstacle to the availability of generic drugs.

The guidance also describes what constitutes a 505(q) petition and some of the factors the agency will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. FDA may deny petitions deemed to have the primary purpose of delaying generic drug entry and may also note this in the publicly posted response to the petition. This, FDA believes, ‘will provide an additional deterrent to pursuing these tactics’.

Related article
Delaying generics using citizen petitions

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA to refer citizen petitions attempting to delay generics to FTC [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from: www.gabionline.net/Guidelines/FDA-to-refer-citizen-petitions-attempting-to-delay-generics-to-FTC

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010