FDA issues new guidance for accelerated pathway for generics

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The US Food and Drug Administration (FDA) announced on 15 February 2019 that it had issued new guidance for its novel accelerated pathway for generics – the Competitive Generic Therapies (CGT) pathway.

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The CGT pathway was introduced in 2017 under the FDA Reauthorization Act of 2017 (FDARA) as part of the agency’s efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines. It gives FDA the authority to designate a drug as a CGT if there is inadequate generics competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their abbreviated new drug applications (ANDAs). Applicants for drugs that receive a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions [1].

FDA says that in order to ‘encourage generic entry for drugs that face inadequate competition’ it is now issuing new, efficient guidelines for the use of the CGT pathway that provides incentives for developing generics of drugs that currently face little or no competition.

Competitive Generic Therapies
Date: February 2019

The guideline aims to provide even greater clarity to industry about the CGT pathway. It provides information on how drug developers can apply for CGT designation and when they may be eligible for CGT exclusivity. The CGT pathway is intended to incentivize effective development, efficient review and importantly encourage the timely market entry of generics.

This guidance comes as part of FDA’s Drug Competition Action Plan, which was announced by the agency in 2017 and has the aim of advancing new policies in order to bring more competition to the drug market. Also, as part of this initiative, the agency recently issued guidance aimed at improving the Orange Book by providing clarity on the information required on marketing status for brand-name and generic drugs [2].

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FDA issues guidance for developers of complex generics

1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first drug via Competitive Generic Therapy pathway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 22]. Available from: www.gabionline.net/Generics/General/FDA-approves-first-drug-via-Competitive-Generic-Therapy-pathway
2. GaBI Online - Generics and Biosimilars Initiative. FDA to improve Orange Book: issues draft guidance on marketing status [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 22]. Available from: www.gabionline.net/Guidelines/FDA-to-improve-Orange-Book-issues-draft-guidance-on-marketing-status

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Source: US FDA

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