FDA Resumes In-Person Meetings with Industry…Sort Of

FDA just announced that it will restart in-person, face-to-face meetings with industry sponsors of drugs and biologics, beginning Feb. 13, after a shift to all-virtual meetings during the COVID-19 health emergency for nearly three years. However, the agency also clarified that it has revised its definition of such formal meetings to include both in-person and virtual components utilizing IT platforms that allow for both audio and visual communication.¹ The agency explains that a face-to-face (FTF) meeting between FDA and industry will be a hybrid session, with both in-person and virtual components using cameras.

This redefinition of “in-person” meetings was agreed on in the recently updated user fee agreements for drugs (PDUFA VII) and biosimilars (BsUFA III). FDA also plans to apply this process to formal meetings involving over-the-counter medicines, even though that new user-fee agreement does not specify this policy. For now, the agency will limit face-to-face hybrid sessions to requests for Type A meetings, Biosimilar Product Development Type 1 sessions, and Type X meetings, with other meeting types continuing to be fully virtual, without an in-person component.

FDA says it is in the process of updating guidance documents for formal meetings to include this revised definition, and is highlighting the new meeting policy on its website to “help reduce uncertainties” for all parties. This dual approach for in-person meetings reflects a hybrid workplace format at the Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), where many staffers still work only a portion of the time at FDA’s White Oak, Md., facility. The agency is upgrading its conference rooms there in phases to better handle hybrid meetings, a process that limits the number of in-person sessions that can be accommodated at this time.

To better manage the in-person component of these hybrid sessions, FDA plans to limit the number of people in the room to “core participants”—i.e., those with “primary speaking roles”—and encourages industry to do the same. Other staffers from both parties will join the session virtually. As FDA gains more upgraded conference rooms, it will consider phasing in additional types of meetings for in-person scheduling, such as Type A and Type B (milestone meetings), BPD Type 1 and Type 2, and Type X and Type Y. Eventually, all FTF formal meetings may be eligible for the in-person format.

Reference

1. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/update-person-face-face-formal-meetings-fda?utm_medium=email&utm_source=govdelivery