Inside US FDA’s Return To In-Person Meetings
Executive Summary
In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.
Some sponsor meetings with US Food and Drug Administration staff will return to partially face-to-face later this month and if the process moves smoothly, any meeting could be made in-person by the end of the year.
Sponsors had been complaining that their requests for in-person sessions with agency staff, as well as advisory committee meetings, had been denied even though the FDA could accommodate them.
Now that more agency staff are working in the office regularly, conducting meetings in person is increasingly feasible. Kevin Bugin, deputy director of operations in the Office of New Drugs, said in an interview with the Pink Sheet that if participants can have a positive experience during Phase 1 of the project, “we can rapidly start to accelerate.”
“I want by the end of the year or even sooner to be able to consider any in-person, face-to-face request that comes across the door,” he said. “It's just a matter of can we do it effectively.”
The Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will allow Type A, Biosimilar Product Development Type 1, and Type X meetings to be conducted in a hybrid format, beginning 13 February. Some participants will attend in-person while others join through video conference, the agency said 30 January on its website.
Type A meetings are for stalled drug development programs, such as dispute resolution or discussions of clinical holds. BPD Type 1 meetings serve a similar purpose for biosimilar development programs. Type X meetings are intended to help stalled over-the-counter monograph development programs or to address safety issues that require immediate attention.
These meetings are held much less often than other types. The agency scheduled 141 Type A meetings in fiscal year 2021 through the prescription drug user fee program. There were 734 Type B and 632 Type C meetings scheduled that year, according to FDA data.
The FDA also scheduled four BPD Type 1 meetings in FY 2021, compared to 64 BPD Type 2 meetings, six BPD Type 3 meetings, 10 BPD Type 4 meetings, and three initial advisory meetings in FY 2021.
Bugin said that the agency decided to offer the hybrid format for those meetings first in part because they were less of them, but also because they are among the most important for sponsors and the agency.
“They are likely to have those more challenging and scientific and complex issues,” he said. “That's where we expect the added value of being in-person can really help.”
Meetings received or scheduled before 13 February “will not be converted to the in-person format to permit fair implementation of the transition,” the agency said. That means that if a firm is particularly eager for an in-person meeting, it should actually wait two weeks to put in the request.
Going forward, the agency gradually will implement the hybrid system for additional meeting types.
“Phase 2 of this transition would permit the consideration of Type A and Type B (milestone), BPD Type 1 and BPD Type 2, Type X and Type Y [face-to-face] formal meetings” for in-person scheduling, the agency said. “The final phase of this transition will enable any [face-to-face] formal meeting to be considered for in-person format.”
The FDA already has held a few hybrid events at White Oak, including a workshop with the audience and speakers present, as well as a virtual attendance option. More similarly structured events are expected in the coming months. (Also see "US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests" - Pink Sheet, 26 Jan, 2023.)
Timetable Driven By Conference Room Upgrades
Only “core participants,” i.e., those with speaking duties, will be allowed in the room during a hybrid meeting in order to limit crowding, but presenters also can participate virtually if necessary.
Bugin said the number of attendees will be limited by the size of the conference room. In addition, the agency will seek to keep every other chair open in order to promote social distancing, meaning maximum capacities of rooms likely will be cut in half.
The FDA is upgrading conference rooms with new equipment throughout the year to accommodate hybrid meetings, including adding noise-cancelling, boom-forming microphones and face-conversation tracking video cameras.
The agency said the total number of conference rooms to be upgraded and project cost was not available because the procurement process is still ongoing.
Bugin said work on three to four conference rooms has started, but many more must be upgraded before a full complement of meetings can be hybrid. He said before the pandemic OND used nine conference rooms for meetings. CDER also must accommodate generic drug user fee and over-the-counter monograph user fee meetings.
Bugin said the agency waited to begin the upgrades until in-office work gained more traction and pandemic restrictions began to ease.
“We're all trying to catch up and I think we were being just sort of good stewards of taxpayer dollars, not rushing to upgrade conference rooms when nobody was really on campus using them, because technology is one of those things where it constantly improving and evolving,” Bugin said.
The agency now is transitioning away from full-time telework for nearly all employees, which became mandatory when COVID-19 took hold, to a “hybrid workplace model,” in part to help recruitment and retention. (Also see "US FDA Implementing Hybrid Work Policy In January" - Pink Sheet, 22 Nov, 2022.)
Stakeholders Excited For In-Person Meetings
Stakeholders were excited at the potential to sit across the table from FDA staff once again, even if some will be on a TV screen.
“I think this is a good thing for industry,” said Matthew Weinberg, president of regulatory sciences for ProPharma Group. “There are some questions best answered with as much discussion as possible. The teleconference meetings have been successful and yet, face-to-face is still a plus.”
Attorney Kathleen Sanzo, a partner and leader of the FDA and health care practice at Morgan, Lewis and Bockius LLP, said the change is “better than nothing,” but worried industry may not be able to have all their experts who worked on an application in the room.
Attorney Frank Sasinowski, a director at Hyman, Phelps and McNamara, said the decision could be an improvement from pre-pandemic sponsor meetings, which included heavily crowded conference rooms with principals sitting at the table and a ring of chairs filled with others surrounding them.
“Having the principal people from FDA, the main speakers as well as those from the company, I think is a huge advance,” Sasinowski said. “I think it will enable that more direct conversation that is necessary to address the complex in-depth issues that often are at the core of these meetings.”
No Plan For In-Person Advisory Committees Yet
FDA officials still are not ready to schedule in-person advisory committees again. Bugin said discussions are ongoing, but no final decision has been made and no plan has been created.
However, Bugin said FDA staff are growing increasingly interested in working in-person during the meetings.
“I've already started to see requests for just the FDA staff to join in-person for the advisory committee so that they can join the meeting virtually, but from the same location,” he said.
One of the FDA’s first hybrid meetings last fall included the FDA speakers meeting together in the agency’s conference center, but with a virtual audience. The group met together in part because many of them already were working in the office. (Also see "In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ" - Pink Sheet, 3 Oct, 2022.)
Many FDA officials also worked in a room together during the virtual withdrawal hearings for Covis Pharma’s pre-term birth prevention medication Makena (hydroxyprogesterone caproate). (Also see "US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close" - Pink Sheet, 19 Oct, 2022.)
Jim DiBiasi, co-founder of 3D Communications, a firm that helps pharma companies prepare for advisory committee meetings, also said his team was in a hotel conference room with officials from Cidara Therapeutics, Inc. for the company’s 24 January virtual advisory committee meeting on rezafungin.
DiBiasi said sponsors are looking forward to reclaiming the advantages of in-person advisory committee meetings.
“Part of the benefit of being face-to-face with a large team is the ability to respond to different agency questions, so limiting attendance to people doing the presenting will limit the effectiveness of the conversations that are the greatest potential benefit of these meetings,” he said.
Some sponsors dislike virtual advisory committee meetings because robust scientific discussions are more difficult. (Also see "Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says" - Pink Sheet, 19 Feb, 2021.)