In-Person FDA Meetings
(Thursday, February 29, 2024) The format of FDA meetings has changed dramatically since the pandemic from mostly in-person to almost all virtual meetings. Should the in-person meetings come back to the pre-pandemic levels? There are several opinions to that debate. This week, FDA’s senior officials opined at a conference on the topic, and it seems there are divergent opinions. Meetings with the FDA are the most valuable resource available to sponsors of applications. Since the first passing of the Prescription Drug User Fee Act (PDUFA) in the early 1990s, meetings with the FDA have been highly productive in sponsor-FDA interactions. Study after study has shown that meetings with the FDA lead to better interactions and increase the odds of positive outcomes exponentially. However, meetings require a lot of resources and make it hard to implement remote work, particularly for the FDA staff. In the pre-pandemic days, there were tens of meetings every day at the FDA campus in Maryland, near Washington DC. Each meeting was attended by 10+ FDA staffers from the most senior to interns. In the last 5 years before 2020, the FDA slowly tried to manage its workload by converting many meetings to the universally hated Written Response Only (WRO) format, which is basically a nicer term for written comments to questions. WRO does not allow discussion with the FDA and delays the outcome of responses to critical questions. In the pre-pandemic times, teleconferences were the second option for in-person meetings. In-person meetings also require significant resources for the meeting requesters as they must travel to Maryland to meet the FDA, but the industry rarely complained about that. The pandemic gave the FDA an opening to experiment with 100% remote meetings, and it did work during the pandemic. Zoom meetings have become the new culture for all meetings. However, the lack of rapport developed when meeting someone in person was lost. The FDA management probably realizes the same. Hence, at a conference this week, several FDAers indicated that the Advisory Meetings will return to the in-person format by this fall. This does not address the other FDA meetings. Advisory Committee meetings are an infinitesimally small fraction of FDA meetings so those meetings returning to in-person format, while welcome, do not do much for the rest of the industry. Last September, the FDA released the new formats for meetings which delineated the FDA’s desire to keep most meetings with sponsors to virtual formats. The FDA managers don’t want to discuss that any further. So, while you might be able to attend in-person advisory committee meetings soon, your non-public meetings with the FDA will stay mostly virtual with a gradual increase in in-person meetings on a case-by-case basis. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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