FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels

Dive Brief:

FDA published a new guidance document Monday aggregating its latest thinking on how the coronavirus pandemic is affecting formal meetings and user fee applications for medical devices.
The question and answer-style guidance affirms earlier agency commentary on the potential for it to miss MDUFA performance goals due to “considerable increases in COVID-19 activities,” its defaulting to teleconferences for meetings with industry, and its consideration of hosting advisory committee meetings virtually.
Separately, FDA on Monday announced a pair of virtual public meetings Sept. 29-30 to discuss using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in medical device evaluation as part of an FDA summit with ISPOR, a professional society for health economics and outcomes research.

Dive Insight:

FDA acted to adapt its policies to the pressures created by the public health crisis in March. Back then, regulators switched to teleconferencing and gave applicants an extra 60 days to respond to requests for more information. The next month, the agency extended that extra period to 90 days and warned the pandemic could prevent it from meeting premarket review timelines.

The guidance published this week affirms that FDA's current thinking matches some of those same points made in March and April.

FDA intends to keep the policies set out in the new guidance in place until the end of the public health emergency. The U.S. has reported more than 140,000 confirmed COVID-19 cases a week since April and, with the figure now rising back up toward 200,000, the crisis looks set to persist.

That suggests emergency measures adopted by FDA in March and April, and reiterated this week in the new guidance, will remain in place for the foreseeable future. The duration of the crisis will affect whether some of the scenarios sketched out in the guidance come to pass.

For example, in line with earlier statements, FDA said it is still evaluating the feasibility of running virtual advisory committee meetings and contends the approach is viable using current technology. A long-term public health emergency will make it harder to simply defer advisory committee meetings.

The duration of the crisis is also a potential factor in FDA’s ability to meet MDUFA timelines. Echoing comments FDA Commissioner Stephen Hahn made in April, the guidance states the agency may not “be able to sustain [its] current performance levels indefinitely” due to the effect of COVID-19 on its deployment of staff.