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Pink Sheet — The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

Pink Sheet — The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

US Food and Drug Administration advisory committees are heading back in person to the agency’s White Oak headquarters this fall after an absence of more than four years.

“First of all, we’re coming back,” Oncology Center of Excellence Director Richard Pazdur said on 26 February. “I think that’s very important to get back in person.”

Pazdur spoke during a panel discussion on advisory committees at the Biopharma Congress, sponsored by Prevision Policy and Friends of Cancer Research.

When the COVID-19 pandemic hit in early 2020, in-person adcomms were cancelled and some were subsequently shifted to online platforms.  (Also see “Virtual Advisory Committees Are Coming: US FDA Panels Will Be Smaller, More Focused” – Pink Sheet, 15 Apr, 2020.)

Although the White Oak, Md. headquarters has hosted some in-person workshops in the past year, drug and biologic adcomms have remained virtual, even though FDA staff sometimes make their meeting presentations from the White Oak conference facility.  (Also see “Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More” – Pink Sheet, 18 May, 2023.)

The many technical problems that beset the earliest virtual adcomms have eased somewhat over the past few years.  (Also see “Virtual Advisory Committees Are Here, And They Will Take Some Getting Used To” – Pink Sheet, 17 Jul, 2020.) However, such meetings still remain problematic in the eyes of FDA officials and the viewing public.

A Different Dynamic

Pazdur said the goal is to have FDA staff, committee members and industry in person.

The OCE director said there have been many times during virtual meetings of the Oncologic Drugs Advisory Committee when he did not know what was going on at a meeting because panelists kept their cameras turned off. He did not see peoples’ expressions and did not even know if they were listening to the meeting.

“The dynamics of the meeting get lost sometimes,” Pazdur said. “There’s all of these verbal and nonverbal cues that exist. Do people smile? Do people have frowns on their faces? We’re less likely to interject in a virtual meeting than if it was a live meeting. It’s just human interaction, basically.”

Office of New Drugs Director Peter Stein also agreed on the need to bring advisory committees back in person.

Although “we’ve been actually rather surprisingly successful with virtual meetings,” the limitations of any virtual platform do not enhance interaction and discussion, Stein said.

“We’re making a transition now. I’m hoping that by fall most of our meetings will be in person.” – FDA’s Peter Stein

“Live meetings have a different tone, and the back and forth, the ability for one member to sort of key off what another member says, whether agreeing or disagreeing, is critical.”

Stein said resuming in-person meetings is a trade-off because although the agency wants its advisory committees to include representatives from diverse backgrounds and geographies, for someone from the West Coast an in-person meeting could involve a two- to three-day commitment, which is challenging.

“We have to be sensitive to that,” Stein said. “But at the same time, the quality of the meetings is clearly enhanced by being in person, and that’s the direction we’re going in. So we’re making a transition now. I’m hoping that by fall most of our meetings will be in person.”

Stein later told the Pink Sheet that the transition back to in-person meetings will be gradual, taking several months or longer. The agency is trying to balance the needs of adcomm members, including the demands on their time and the need to schedule travel, with the agency’s desire for in-person interactions and to get the right expertise on each panel.

The agency has yet to announce specific plans for an in-person adcomm. However, Pazdur said he was going to be talking to ODAC members about resuming in-person meetings.

“20,000 oncologists go to an ASCO meeting in Chicago. You’d think they can get their butts on an airplane,” Pazdur said.

Stein said some aspects of adcomms will remain virtual. He specifically cited the opportunity for open public hearing speakers, who often are patients, to appear virtually.

“So that’s going to continue. But we will otherwise I think try to move as much as we can towards in-person meetings. And will they be hybrid? Probably, but we really” are trying to get the panel members in person, he said.

Re-examining The Chairman’s Role

Pazdur also has other changes in mind for ODAC in the weeks and months to come, including rotating the panel chairman when there are multi-day meetings involving multiple drugs.

In addition, “I think it’s very important that we really examine the role of the chairman,” Pazdur said,

“The chair is not an emcee. The chair is not an Ed Sullivan. … It should be a moderator that is bringing in people into the discussion.” – FDA’s Richard Pazdur

“The chair is not an emcee. The chair is not an Ed Sullivan,” he said. “It should be a moderator that is bringing in people into the discussion.”

Instead of spending an excessive amount of time on clarifying questions, Pazdur wants to see committee members spend more time discussing the most pressing issues with an application. “Here again, it is the role of the moderator to start bringing in people.”

If the chairman reads the question or discussion point and panelists are not engaging in discussion, the chair needs to start bringing committee members into the conversation, such as specifically asking the panel’s statistician or disease experts to weigh in, he said.

“Those are some of the major issues that I’d like to really rapidly initiate as we move back to more live meetings,” Pazdur said.

Although ODAC is scheduled to meet virtually two days in March, this session could provide an opportunity for Pazdur to test out some of the changes he wants to make.

ODAC will meet on 14 March to discuss Geron Corporation’s application for imetelstat for treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.

On 15 March, the committee will consider supplementary multiple myeloma indications for two CAR-T products, Janssen Biotech Inc.’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Company’s Abecma (idecabtagene vicleucel). The committee will discuss overall survival data for both products as well as their benefit-risk profiles, including a class-wide safety signal of secondary malignancies.  (Also see “CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions” – Pink Sheet, 23 Jan, 2024.)