The US Food and Drug Administration (FDA) has released guidance on generic drug development and the submission of abbreviated new drug applications (ANDAs) during COVID-19, which explains how manufacturers can overcome issues caused by the pandemic.
The COVID-19 pandemic has impacted drug development in a number of ways, for example, by disrupting supply of ingredients and delaying inspections of manufacturing plants. In 2020, FDA released a comprehensive statement regarding the impact of the pandemic on the medical supply chain [1].
In April 2021, the Administration released new guidance for industry on the development of generic drugs during the COVID-19 pandemic, as a series of questions and answers. The document is a compilation of questions received from applicants during COVID-19 relating to:
Generic drug development
- Expiration of test product batch due to study interruptions
- Expiration of reference product batch due to development programme interruptions
- Use of non-US approved product as reference standards
- Efforts to maintain social distancing at study sites/laboratories
- Submission of study data with a truncated sampling scheme
- Alternative study proposals, such as interim analysis or remote study design
ANDA submission and assessment
- Expedited ANDAs for generic drug products against COVID-19
- Receipt evaluation for ANDAs for generic drug products against COVID-19
- ANDAs without the recommended batch stability data
- ANDAs with incomplete bioequivalence study data
- ANDAs including sites that cannot be inspected due to travel restrictions
Marketing and exclusivity
- Marketing of tentatively approved generics that could be used against COVID-19
- The impact of inspection delays on eligibility for 180-day generic exclusivity
FDA says it recognizes that the COVID-19 pandemic has impacted the development of generic drug products, by interruptions to bioequivalence studies for example. The guidance clarifies what to do in these situations, where test or reference product may have expired. It also explains that the Administration will expedite the assessment of products that could be used to address the COVID-19 pandemic, although ANDAs will generally still require a full complement of batch stability data and completed bioequivalence study data. The Administration will not however reject an application on the basis that it includes sites that cannot currently be inspected and will consider any inspection delays in 180-day exclusivity decisions.
In total the guidance includes 15 Q & As, which can be read in full on the FDA website.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA’s response to coronavirus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Pharma-News/FDA-s-response-to-coronavirus
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