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FDA agrees to meet GAO demands on revised guidance for complex generics

Home/Guidelines | Posted 09/02/2018 0 Post your comment

The US Government Accountability Office (GAO) released a report on 16 January 2018, in which it stated that the US Food and Drug Administration (FDA) should release plans to issue or revise guidance for complex generic drugs. FDA made an official response in which it laid out its plans for the future which address many of the GAO's concerns.

In the report, GAO highlighted a number of issues related to complex generic drug approval and uptake in the US. They noted that some companies have criticized FDA for the timescale on which new complex generics reach the market. In addition, some brand sponsors have said that the FDA guidance does not adequately address the scientific complexities of NBCDs (non-biological complex drugs). Sponsors also noted that the guidance for some NBCDs was revised many times without the industry being notified in advance. After carrying out research into the literature, GAO realized that there are often problems in establishing that brand and generic active ingredients are equivalent if the drug’s structure and other properties cannot be fully characterized.

In response to the report, FDA notes that they have been working to improve processes for reviewing and approving complex generic drugs. The agency highlighted that, since 2007, it has published over 1,500 product-specific generic drug guidances. It also noted that they are in the process of evaluating the impact of its Drug Competition Action plan [1] that was first announced in early 2017. This action plan was put in place to advance new policies aimed at bringing more competition to the drug market. Following this, on 2 October 2017, FDA announced a new set of policies that aim to make it easier to achieve generics competition for complex drugs [2]. In their report response they highlight that they are continuing to develop additional guidance for industry to clarify the 'sameness' requirements for ANDAs (abbreviated new drug applications) and they have plans to issue a specific guidance on drug-device combination products.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition
2. GaBI Online - Generics and Biosimilars Initiative. FDA trying to reduce hurdles for complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Generics/General/FDA-trying-to-reduce-hurdles-for-complex-generics

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Source: US FDA