FDA issues final guidance on petitions delaying generics

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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.

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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

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This final guidance replaces the draft guidance that was released in October 2018 [1].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’.

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Delaying generics using citizen petitions

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

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Source: US FDA

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