In April 2021 the FDA released a new question & answer guidance document for the industry, specifically addressing Generics and their challenges during the COVID-19 pandemic. As the guidance is coming into effect immediately without prior public comments, it is worth having a closer look.
The FDA has issued this guidance to provide general recommendations to (prospective) applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions. The FDA has collated the questions and is presenting the responses in this guidance document for the benefit of all stakeholders. The FDA intends to revise/update this guidance as appropriate.
What does the guidance contain?
The guidance document has been structured into the following categories:
A) Generic drug product development;
B) Submission and assessment of ANDAs; and
C) Marketing and exclusivity.
Each category addresses different areas of concerns.
Category A: Generic drug product development
Questions in this category are mainly about bioequivalence studies and how any study interruption can be handled and whether multiple batches of reference products can be used in particular circumstances.
Category B: Submission and assessment of ANDAs
Questions in this category mainly address concerns about ANDA submissions for medicinal products that help with the COVID-19 public health emergency and possible site inspections that cannot take place because of restrictions invoked by the COVID-19 pandemic.
Category C: Marketing and exclusivity
Questions in this category address tentative drug approval and any impact of COVID-19 on timelines, specifically on exclusivity for Generics.
What other support is available for Generics?
Although not directly linked to the COVID-19 pandemic, the FDA has just launched the “Generic Drug Cluster” to improve global regulatory alignment among agencies, specifically in countries with focus on development of generic medicines. The “Generic Drug Cluster” aims to increase scientific alignment with the following objectives:
• Achieving a common understanding of each Agency’s regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.
• Offering a confidential forum for exchange of discussion on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies.
• Provision of a forum for a discussion of general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.
• Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.
Hopefully other agencies will also see a benefit in this forum to support global generic drug development.
With this Q&A guidance for industry, the FDA has addressed some of the questions faced by the Generics industry, in particular about the possible impact of the COVID-19 pandemic. The FDA provides some of the options available to the industry for handling studies and batches used to conduct bioequivalent studies as well as inspections. For Generics it will be a relief though that the FDA is not automatically rejecting applications that include sites that cannot be inspected because of COVID-19 restrictions. Approval decisions will be based on the entire information available. A key point is that marketing of a tentatively approved ANDA will not be possible.
With the recently launched “Generic Drug Cluster”, the FDA opened a communication forum for the world’s leading regulatory agencies to address generic drug development globally. Let’s hope that other agencies will also see a benefit in this forum and participate.