The US Food and Drug Administration (FDA) has released a guidance document that aims to reduce the time that it takes for safe and effective generics to reach the market.
The final guideline on abbreviated new drug application (ANDA) submissions was published in Federal Register announcement on 25 September 2018. The guideline is intended to assist applicants in preparing ANDAs for submission to FDA. It identifies the information an applicant should include to ensure that a complete, high quality application is submitted to FDA.
ANDA Submissions-Content and Format Guidance for Industry
Date: September 2018
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400630.pdf
The guideline incorporates comments received since the draft guidance was issued in 2014. The new document outlines the information for applicants to provide in each section of the portion of the ANDA known as the ‘common technical document’ or CTD format. The guidance identifies supporting guidance documents and recommendations to assist applicants in preparing more complete, high quality ANDA submissions.
Historically up to four review cycles were needed due to insufficient information in the application. ‘These multiple cycles of review are costly and inefficient’, says FDA Commissioner Dr Scott Gottlieb. This guidance therefore seeks to reduce application cycles by clarifying for industry how they can submit complete, high quality applications from the start.
According to Commissioner Dr Scott Gottlieb, FDA has ‘been implementing measures to improve the efficiency’ of its reviews, as well as prioritising applications for generics of medicines without competition. In June 2017, the agency released guidance to speed up the review of priority generics, i.e. medicines with no approved generic version [1]. But he points out that the agency is also continuing to look at how it ‘can assist companies in submitting higher quality and more complete applications that are less likely to undergo multiple cycles of review before receiving FDA approval’.
In September 2018, FDA also released 54 product-specific draft guidances with the aim of promoting access to generics and increasing drug price competition [2].
FDA is not the only one in the US trying to reduce the time it takes for generics to hit the market. The Congressional Budget Office believes that the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is currently awaiting a vote in the Senate, ‘would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law’. The CREATES Act aims to prevent anticompetitive practices that delay or even block the market entry of generics and was first introduced in June 2016 [3] and subsequently revived in June 2017 [4].
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FDA issues final guidance on ANDA/PAS amendments
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA to speed up review of priority generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Guidelines/FDA-to-speed-up-review-of-priority-generics
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases product-specific guidance to increase generics competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Guidelines/FDA-releases-product-specific-guidance-to-increase-generics-competition
3. GaBI Online - Generics and Biosimilars Initiative. New bill would stop brand-name pharma restricting drug samples [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Policies-Legislation/New-bill-would-stop-brand-name-pharma-restricting-drug-samples
4. GaBI Online - Generics and Biosimilars Initiative. US Senate revives the CREATES Act [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Policies-Legislation/US-Senate-revives-the-CREATES-Act
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Source: CBO, Federal Register, US FDA
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