Meetings with FDA, As You Have Known, May be History
[Thursday, May 28, 2020]
FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps bite the most for the regulated industry that has come to depend heavily on in-person discussions with the FDA reviewers at these meetings. The announcement was made in the form of a new Guidance Document, giving it the perception of permanent policy, although the document mentions that “this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19”. This is an obvious change due to the need for social distancing. In effect, FDA has apparently not held any in person meetings since the pandemic was declared so the guidance only formalizes what was already in effect. The guidance also clarifies that this policy for virtual format is applicable not just to the PDUFA and other XXUFA meetings but also to Advisory Meetings and almost all other interactions. No exceptions have been included giving the FDA absolute discretion to deny all in person meetings. One could argue that all discussions can be effectively held with FDA via phone meetings; we are able to work from home so why can’t we also meet FDA. But practically, face-to-face interactions cannot be completely replaced by phone and written discussions. That is the reason in-person meetings are overwhelmingly preferred by sponsor over any other format of meeting. These meetings have also helped humanize the FDA review process whereby the sponsors get to meet the reviewers and have a personal interaction not feasible in a phone meeting. And all bets are that FDA would need to bring these meetings back. But FDA has been trying to reduce in-person meetings for some time now. The pandemic could seem like a good opportunity to implement a policy preferred by FDA. Hope it is not that cynical, and that this is indeed a temporary policy. At the same time, it would not be hard to imagine FDA restricting the criteria for in-person meetings even after the emergency is over. All indicators are that the social distancing policies are here to stay at least for the next several months, may be a year or more. As the industry gets used to the phone meetings and written responses, we may not miss the in-person interactions as much and lose the personalized, humanized FDA we have all come to trust. Maybe we are being too old-fashioned and emotional about the anachronistic concept of in-person interactions when virtual interactions are all we needed.