Q&A guidance from the FDA on generic drug development during COVID-19

The US Food and Drug Administration (FDA) has published a Q&A guidance concerning abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic.

The guidance addresses 15 questions split into three key sections, the first of which covers generic drug product development. The questions in this section run on the assumption that bioequivalence (BE) studies needed to support ANDA submission and approval have been interrupted or unable to start due to the pandemic. Consequently, the questions and answers in this section are focussed on helping manufacturers resolve these issues. Potential solutions for interrupted BE studies involve manufacturing a new batch and/or using two or more batches of the reference product. For prospective ANDA applicants, the FDA is open to alternative study proposals as long as these are communicated prior to the study commencing.

The second section covers ANDA submission and assessment. The responses in this section deal with the submission, receipt and assessment of ANDAs for drugs used to address the COVID-19 public health emergency and for drugs in which their development has been impacted by COVID-19. Applications for ANDAs that may be used to help combat the pandemic will be expedited, these ANDAs will still be subject to a receipt evaluation. The FDA also details the flexibilities related to supplying the recommended batch stability data and the inclusion of sites that cannot be inspected due to travel restrictions.

The final section details the FDA opinion on marketing status and exclusivity that may be granted. The agency may tentatively approve a generic drug product that could be used to address the COVID-19 pandemic in situations where an unexpired patent(s) or exclusivity(ies) prevents a full approval. Note that a tentative ANDA cannot be converted to a full approval until the ANDA meets all the necessary requirements for a full approval. The FDA also details the case-by-case approach it will take when assessing the impact of its inability to conduct certain inspections on an applicant’s 180-day generic drug exclusivity.

It is important to note that the guidance is only intended to remain in effect for the duration of the COVID-19 public health emergency.

To view the guidance in full, click here.