Late-breaking presentation on new draft guidance
On Wednesday afternoon, the highly anticipated late-breaking presentation by Rik Lostritto of the FDA took place by teleconference. Lostritto began by saying that he wanted to provide some history and context for the 1998 draft guidance, which he said was produced by FDA staff while they worked on other projects, while the new draft guidance project was prioritized as part of a 2015 initiative.
He noted that the comment period for the new draft guidance for MDI and DPI quality concerns ends June 18, 2018 and provided instructions for both public and confidential comment submissions. Lostritto explained that comments would be grouped into categories, with staff and subject matter experts assigned to evaluate each category. If the FDA decides that no major changes are warranted, he said, the final draft guidance might be published after the review; otherwise, another draft might be required.
Lostritto highlighted several sections of the guidance that represent significant changes, including lines 104-128 regarding design controls, which he called “a big deal”; lines 580-582, which say “For DDU, the Agency also supports alternative statistical approaches using parametric tolerance interval testing (PTIT), because these approaches are more relevant for assuring the overall quality of the entire batch of an MDI or DPI”; and lines 1563-1601, which include a worked example using PTIT for DDU evaluation.
Questions for Lostritto included procedural issues such as whether the FDA would consider extending the comment period and whether the agency would consider holding a public meeting once it has received all comments. Lostritto responded that he was open to those ideas and asked that suggestions be submitted to the agency.
Other questions regarding the scope of the draft guidance elicited a less accommodating response. Several people, including John Patton of Dance Biopharm, raised the issue of guidance for devices other than MDIs or DPIs, such as the vibrating mesh liquid inhaler used for Dance’s inhaled insulin. Lostritto said that he understood the concerns but warned that requests for inclusion of those types of devices would delay issuance of a final guidance.
Session on improved testing and regulatory guidance for generics
The scheduled session on “Expanding the Marketplace for Generic Inhalers via Improved Testing & Regulatory Guidance” on the final day of the meeting featured talks by Rob Lionberger and Kimberly Witzmann of the FDA, Dennis Sandell of S5 Consulting, Rob Price of the University of Bath and Nanopharm, and Steve Stein of 3M DDS (representing IPAC-RS). Sanjeeva Dissanayake of Certior Consulting, who was unable to attend in person, provided a voice over for his slides.
