FDA May Be Considering Ending In-Person Meetings with Sponsors
(Thursday, June 3, 2021)
FDA is considering continuing virtual meetings with the sponsor even after the pandemic, announced CDER’s Director, Dr. Patrizia Cavazzoni, at a public meeting last week. Its reasoning that sponsors would find virtual meetings convenient over the hassle of traveling to FDA’s offices, seems to be based on anecdotes rather than formal surveys or any studies. FDA meetings are one of the most important avenues available to sponsors to get feedback from the reviewers on critical matters. Multiple studies by independent analysts have demonstrated their benefits to both sponsors and the FDA. But all those analyses were primarily based on review of in-person meetings, not virtual meetings. FDA itself has touted the importance of sponsors having conversations with it at critical time-points in the development of their products. The format of these meetings is the most important aspect of the value they bring to the sponsors. A telephone call is not equivalent to sitting across the table with someone to discuss. It forces both parties to prepare differently and strive to consensus. One cannot ignore the importance of body language in such meetings. There is no evidence that sponsors find these meeting onerous or inconvenient. On the contrary, almost all independent studies have demonstrated that sponsors look at these meetings as critical events in their development milestones. FDA should not make one-side decisions about the format of FDA-sponsor meetings. It has already made several changes in its policies regarding Sponsor-FDA meetings such as denying significant portion of meeting requests by providing “Written Response Only”, allowing only one meeting of each kind, increasing the time between initial request and meeting dates, and converting routine meetings to telephone calls only. The policy change to grant only virtual meeting could be the final straw to make these meetings less valuable to sponsors. It took decades for FDA to rewrite perceptions about it being a black box to an agency that believes in transparency and openness regarding its reviews. Virtual meetings seem like a major step back. At the least, FDA should collect public comments before implementing this major policy change.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC