As Bob has previously blogged on the highlights from AAM day by day, let me take a moment to dive a bit deeper into one of the sessions. As an attendee of this meeting for several years, one of the best things about AAM’s GRx+Biosims is that sessions at this meeting often offer a mix of regulatory knowledge and industry experience. The partnership between the FDA presenting on topics by highlighting guidance and best practices with Industry offering their feedback, and suggestions for improvement and collaboration as point and counterpoint that is often followed by lively and productive Q&A, has always marked the best and most talked about sessions. The session on Nitrosamines at this year’s meeting, however, didn’t follow that patten. While the session was titled Nitrosamines and Harmonization, the panel was entirely made up of industry presenters. They spoke on their company’s experiences working with the FDA and other health authorities and presented information on the ways that they have worked to achieve a harmonized approach to control nitrosamine impurities within their companies and highlighted some of the challenges that they are still working through. The speakers also offered thoughts on ways to work toward closer harmonization by allowing the use of less-than-lifetime limits and leveraging global data sharing options to better align limits published by each health authority.
The key takeaway for many in the audience was not the thoughtful recommendations for the FDA or the insights offered into each company’s experiences, but rather it was the lack of attendees from the FDA who were in the room to hear it. The FDA’s absence was noted on the panel as the moderator commented that many of the submitted questions were directed to the FDA or other health authorities, but there was also a lack of attendees in the audience representing the FDA that was discussed by my tablemates. I am sure it was not an oversight on AAM’s part, and while there were several other sessions offered at the same time that were competing for everyone’s attention, however, communication is a mantra frequently mentioned by the FDA, and it would have been nice for the FDA to hear our concerns and provide their input.
The path to harmonization must be walked together. As panelist Nalin Karka, General Manager of Sun Pharmaceuticals mentioned, the discovery of nitrosamine impurities in drug products and the subsequent regulatory requirements imposed by the FDA and other global health authorities, has been one of the most significant disruptors to the generics industry to-date. With supply chains already strained and pricing pressures ever prevalent, some companies may be forced to choose between markets they can support or even what products they can continue to produce to ensure more divergence in global access and avoid an increase in drug product shortages where the cost of keeping the product on the market outweighs the costs to bring it into compliance.
Perhaps the FDA’s absence at this meeting was due to the upcoming Centers for Research on Complex Generics 2-day workshop on Nitrosamines coming up on November 6th and 7th (here’s a link to the meeting website for more information). The upcoming workshop offers virtual attendance as well as in-person. According to the website, the workshop will share the latest research and recommendations for detecting NDSRI formation, as well as strategies to mitigate risks of their formation and ensure compliance with evolving regulatory requirements. Also noted on the website, the workshop is another opportunity to get up-to-date information on the latest guidance and recommendations on formulation stability and bioequivalence approaches and hear firsthand from experts on regulatory approaches for pre- and post-approval changes in ANDA/NDA submissions and supplements. Hopefully, some of the same suggestions offered by industry from yesterday’s AAM session on nitrosamines will be echoed at the workshop and there will be an opportunity for industry members to ask their questions in that forum as well as to hear directly from the FDA that was missing from this meeting.
If you need further assistance with nitrosamine impurity issues, please contact Lachman Consultants at www.lachmanconsultants.com/contact/.
