Best Practices for Meetings with FDA: New Guidance, “Old” Information 

Sometimes you see a new guidance document from FDA and you scratch your head, trying to understand the intent of this new document and then it dawns on you; FDA is trying its best to help the novice sponsors understand internal processes. Last week, FDA released a new Guidance Document on best practices to discuss with FDA, not just in meetings with the reviewers but also other ways such as emails, phone calls, faxes (if you still use them), and by making submissions asking specific questions. If you have a reasonable experience interacting with FDA in the recent past, this is not for you. The guidance is clearly intended to verbalize practices that have existed for a few years now. The guidance describes in great details FDA’s practices for advising sponsors, and provides tips on when to meet or not to meet FDA, what kind of questions to ask, who to approach, and what to expect. This document clearly links to the Enhanced Communication initiative launched in 2013. This document is expected to be supplement the numerous previous FDA guidance documents on requesting meetings with FDA such as that for formal meetings for drugs and biologics, meetings for biosimilars, end-of-phase 2 meetings, and good review management. This guidance only applies to drugs and biologics, and not to medical devices. A major observation from this new guidance document is the emphasis on the importance of Project Management staff at FDA. The Regulatory Project Manager (RPM) is the “primary” contact for sponsors from FDA and the “co-leader” of the review team. Any direct contact with the FDA reviewers is strongly discouraged. Sponsors are advised to always contact only the RPM, and if they are not satisfied with the RPM, then escalate it to the Chief of the Project Management Staff (CPMS). Very rarely is a sponsor allowed to directly communicate with the reviewers and even if somehow a sponsor is able to talk to a given reviewer, it is advised that any advise coming out of such interaction will not be considered as formal advise by FDA unless documented by the RPM. It may seem to a novice that FDA is adding increasing distance between its reviewers and sponsors, and that it is taking a turn towards increased red-tape but it may be a defense mechanism to protect its reviewers by adding extra layers of internal reviews before any information is released to a sponsor. It is clear FDA wants to control communication of all sorts. In the past a common complaint from sponsors was a given reviewer being perceived as being overtly zealous in applying seemingly unrelated scientific logic or being unfairly biased towards a given product or sponsor. By involving multiple layers of review of opinion by a given reviewers, complaints of bias can be blunted, if not eliminated. Also, it is good project management practice to control communication and enforce timelines. Under the new rules for example, the RPM is expected to respond to a sponsor’s request within 3 business days. This guidance has several elements similar to another guidance document released by CDRH for medical device meetings last year. This is an essential read for anyone new to FDA interactions. It may have much more details that any one sponsor would probably need. It may also discourage some sponsors to not seek meetings with FDA. By trying to emphasize the administrative aspects of meetings, this guidance gives an impression of project management taking precedence over scientific interactions, which is probably not the intent. FDA is an excellent collaborator to a given sponsor and strives to educate stakeholders about its internal processes. This guidance should be read as a supplement to the previous guidance documents that describe the scientific aspects of FDA meetings.