Science, outreach, development: US Generics Drugs Office reaches new highs in 2019 Posted 24/04/2020

The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also discussed the progress of the FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme [4], and information about the achievements of the Office of Generic Drugs (OGD) in terms of research proposals, outreach activities and international development.

In their report, the OGD noted that it was awarded 14 new research contracts and 3 grants for innovative research projects on generic drugs. These contracts and grants were all designed to help advance generic drug development and their safe and effective use and align well with the FDA’s current regulatory science priorities. One research project aims to explore the development of model-informed bioequivalence evaluation strategies for long-acting injectable products – this is likely to help ensure that generic versions of long-acting injectable drugs deliver the same, effective dose as brand-name versions. Another project aims to develop a new data tool that focusses on text analysis and machine learning.

In 2019, the FDA’s generic drug programme conducted more than 50 GDUFA science and research projects. These investigated aspects of complex drug products, evaluated inhalers, and assessed the safety and efficacy of generic drugs used to treat patients with low thyroid levels (which requires precise dose delivery to avoid unwanted side effects). The report noted that the laboratories also developed new analytical technologies that are designed to ensure generic drugs deliver the same amount of medicine as their brand-name counterparts and ensure the quality of the generic.

The OGD also worked with the Center for Drug Evaluation and Research (CDER) to educate and inform the pharmaceutical industry and other stakeholders about FDA’s generic drug programme and GDUFA. They held public meetings and workshops on complex generic drug development, regulatory science initiatives, and regulatory guidances and processes. In 2019, they also sponsored, co-sponsored, and/or participated in six regulatory science meetings and workshops that focused on generic drug development and GDUFA. Through this, it is estimated that they interacted with over 10,000 stakeholders.

The OGD also worked to help improve international development and access to generic products. They are advocates of global harmonization on scientific and technical standards for generic drugs. As such they worked with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to endorse the first ever ICH guidelines that focus on generic drugs.

The report concluded that, in 2020, and beyond, public health will remain of paramount importance to FDA. It has already published its 2020 plans for issuing new and revised Product Specific Guidances for complex drug products [5]. In sharing tools such as this, and in continuing to reach targets as they did in 2019, the Office hopes that US citizens will continue to have improved access to high quality, affordable generic drug products.

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