US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

Source: Illustration

The FDA may have to conduct virtual advisory committee meetings for some applications should coronavirus restrictions on public gatherings continue.

Sponsors moving applications through the US Food and Drug Administration assessment process should not assume that advisory committee meetings are off the table while the coronavirus is preventing public gatherings.

Office of New Drugs Director Peter Stein said in an interview with the Pink Sheet that the agency can conduct the meetings using alternative methods and may do so if necessary.

“Obviously, it will depend on how long the current situation lasts,” Stein said during the 27 March interview. “The longer it continues, obviously the more advisory committees that would have to be considered for moving into that kind of virtual environment. But we have the capabilities and if need-be we could get the advisory committee [meeting] using that kind of approach.”

Peter Stein

Federal law does not require the FDA to conduct advisory committee meetings for every new drug application considered. But the agency often uses the panels of outside experts to gather advice on particularly difficult questions or to discuss the first product in a new drug class.

Stein did not say that the agency was considering policy adjustments for determining when an advisory committee is necessary because of the coronavirus outbreak. He said that several ideas for virtual advisory committee meetings are being considered. No final decision has been made, but “that’s where I think we’ll go if we need to,” he said.

“As we decide that we need an advisory committee for a drug prior to approval, we’re going try to see if we can work through other means of holding those advisory committees,” Stein said. “Doing it virtually. Doing other things. That’s being investigated right now.”

Stein’s comments come as the agency has been forced to postpone or cancel many public meetings, including some advisory committee meetings, that were scheduled in March and April to help slow the spread of the coronavirus. Containment efforts also include converting internal and sponsor-agency meetings from in-person to teleconferences. All FDA staff who are eligible also now must telework. (Also see "As US FDA Settles Into Teleworking, Will Application Reviews Be Affected?" - Pink Sheet, 24 Mar, 2020.)

Despite the disruption of the FDA workflow, Stein has said that teleworking will not force adjustments to user fee goals (Also see "US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework" - Pink Sheet, 29 Mar, 2020.), but Center for Drug Evaluation and Research Director Janet Woodcock indicated some work may be set aside in areas particularly busy with coronavirus-related activities. (Also see "CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’" - Pink Sheet, 31 Mar, 2020.)

Would A Sponsor Elect To Wait For In-Person Adcom?

The FDA is experienced in offering virtual access to its advisory committees – for years most have include a webcast option along with in-person attendance. But conducting them solely via the Internet could be a challenge.

Questions may arise about the accommodations that may be required to allow public comments during the meeting, where patients, advocates and others offer thoughts on the application at hand. As many people have discovered since the coronavirus took hold in the US, meetings conducted via videoconference are not always smooth and technical issues could hinder some speakers’ participation. Submitting written comments to the docket may become a more popular alternative.

Attorney Jim Czaban, a partner at Loeb and Loeb, also told the Pink Sheet that sponsors may want to consider the benefits of an in-person meeting that would be conducted later, versus a more immediate virtual meeting “just due to the persuasive and interactive value of being in the same room, face-to-face, with the AdCom members and FDA when trying to persuade them of the merits of their product and data.”

Attorney Chad Landmon, a partner at Axinn, Veltrop and Harkrider, also said that video conferencing technology by nature may not encourage a robust discussion among the committee members and could impact the outcome.

The FDA has scheduled a virtual public meeting to kick-off the medical device user fee reauthorization process that may provide a model for an advisory committee set-up. Oral presentations will be allowed during the 5 May meeting, the agency said in the meeting notice. Online registration was required, and the agency said “we will do our best to accommodate requests to make public comments,” but otherwise the notice did not appear to include any specific adjustments to support the teleconference.

Many Postponements, But Another In-Person Meeting Has Been Scheduled

Several advisory committee meetings have been postponed, including:

• A 21 April Pulmonary-Allergy Drugs Advisory Committee session on Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol inhalation powder).GlaxoSmithKline PLC has proposed adding reduction of all-cause mortality in patients with chronic obstructive pulmonary disease to the label. (Also see "Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements" - Pink Sheet, 5 Oct, 2019.)

• Eli Lilly & Co.’s Avid Radiopharmaceuticals Inc. also was scheduled to go before the Medical Imaging Drugs Advisory Committee on 23 April to discuss its radioactive diagnostic agent flortaucipir F18 intravenous injection, which was proposed for positron emission tomography imaging of the brain to estimate density and distribution of aggregated tau neurofibrillary tangles of Alzheimer’s disease. (Also see "Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula" - Pink Sheet, 24 Oct, 2019.)

• An advisory committee meeting for Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA), which is proposed for non-alcoholic steatohepatitis (NASH), also was postponed after being tentatively scheduled for 22 April. The company released the date, but the FDA never officially announced the meeting. (Also see "Intercept’s NASH Drug Delayed By April Advisory Committee" - Pink Sheet, 16 Dec, 2019.)

Intercept has now announced that the advisory committee will be held on 9 June, but as before, the FDA hasn't said anything. 

June seems to be when FDA officials expect to see the extraordinary coronavirus containment measures lifted, though. The agency announced on 1 April that an in-person Ophthalmic Devices Panel meeting had been scheduled for 9 June.

Another advisory committee, for DBV Technologies SA's Viaskin Peanut, had been set with the Allergenic Products Advisory Committee for 15 May 2020, but was delayed because of efficacy questions from the agency. (Also see "Palforzia Peanut Allergy Immunotherapy: Aimmune CEO On REMS Restrictions, Manufacturing" - Pink Sheet, 16 Mar, 2020.)