Source : 'Generics Bulletin'
The US Food and Drug Administration has published fresh guidance giving abbreviated new drug application developers advice on how to operate during the COVID-19 pandemic, in the form of a question-and-answer document to address queries received by the agency.
Noting that the guidance was “intended to remain in effect only for the duration of the public health emergency related to COVID-19,” the agency said it was being implemented “without prior public comment, because FDA has determined that prior public participation for this guidance is not feasible or appropriate,” adding that it would continue to revise and update the guidance “as appropriate” to address new questions.
Three categories of query are covered by the Q&A document, covering generic drug product development; submission and assessment of ANDAs; and marketing and exclusivity.
On questions around generic product development, the FDA said that the eight questions and answers in this section addressed concerns based on the assumption that “bioequivalence studies being conducted to support the submission and approval of an ANDA have either been interrupted or have not started due to the COVID-19 public health emergency.”
“As a result, prospective applicants are faced with difficulty obtaining reference products (i.e., the reference standard, which in most cases also will be the reference listed drug) or with expiring reference products and/or test products.”
Meanwhile, in a section on ANDA submission and assessment, the FDA guidance addresses five questions that cover both drugs that could be used to help address the COVID-19 crisis along with those that have simply had their development process impacted by the pandemic. These include questions around whether a product will be eligible for expedited priority review, as well as procedural questions around review requirements.
On the question of whether applications linked with sites that cannot be inspected because of travel restrictions will automatically receive a complete response letter, the agency states that “applications will not automatically receive a complete response letter if FDA cannot conduct an inspection,” but says “decisions regarding applications will be based on the totality of the information available to FDA.”
Finally, two questions and answers on marketing and exclusivity confirm that “there is no mechanism by which FDA can convert a tentatively approved ANDA to final approval and permit marketing until the ANDA meets all the requirements for final approval,” even in cases where a tentatively approved generic could be used to help address the COVID-19 public health emergency.
And discussing the FDA’s inability to conduct certain domestic and foreign inspections due to COVID-19 – and the impact this could have on forfeiture of a first applicant’s eligibility for 180- day generic drug exclusivity – the agency concludes that “whether FDA’s inability to conduct certain inspections will factor into 180-day exclusivity decisions will be determined on a case-by-case basis.”
By David Wallace