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FDA moots virtual AdComms but delays GSK, Intercept meetings

BioTech

FDA moots virtual AdComms but delays GSK, Intercept meetings

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The FDA has expressed an openness to using virtual advisory committee meetings to mitigate the restrictions on face-to-face interactions imposed by COVID-19. However, that openness is yet to translate into action, with the FDA delaying meetings to discuss submissions by GlaxoSmithKline and Intercept Pharmaceuticals rather than having people participate remotely. 

Mark Senak, a lawyer who works at FleishmanHillard, published details of the FDA’s thinking about virtual meetings on his Eye on FDA blog. The blog post features verbatim FDA responses to four questions posed by Senak, including a query about whether the agency plans to try to hold virtual advisory committee meetings. The FDA’s response left the door open to the approach.

“As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation,” the FDA said. 

The response suggests the FDA may be able to continue moving drugs through the approval process even if it is unable to get groups of experts into the same room to discuss the merits of filings. However, for now the agency appears more inclined to postpone advisory committee meetings than to hold them virtually.

Thursday, Intercept said the FDA has pushed back a planned advisory committee meeting to discuss a filing for approval of Ocaliva in nonalcoholic steatohepatitis. Having originally been tentatively scheduled for April 22, the meeting is now penciled in for June 9. The FDA kept the PDUFA action date of June 26 despite the delay to the expert meeting.

Earlier in the week, the FDA postponed a meeting of outside experts to discuss GlaxoSmithKline’s filing for approval of Trelegy Ellipta. The GSK meeting, which was due to take place the day before Intercept’s advisory committee, has been “postponed until further notice.”

If restrictions on face-to-face interactions remain in place in June, the FDA will need to decide whether to hold advisory committee meetings remotely or delay approval decisions. Senak asked the FDA whether it expects to miss PDUFA dates.

The FDA responded: “CDER is fortunate to have existing policies on the use of flexible workplaces, as well as the IT infrastructure to support a large number of staff simultaneously working offsite This gives us the ability to ensure the safety of our workforce and the continuity of our important public health mission during government disruptions. CDER remains fully capable to continue daily activities.”

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