FDA Reviews Likely to Slow as COVID-19 Workload Increases

FDA Commissioner Stephen Hahn said the agency is meeting its user fee-related review goals for now as the COVID-19 outbreak rages, but the agency may not be able to sustain its current workload.

Hahn said the agency is working at full capacity to ensure that the drug programs continue to see minimal interruptions, but it will need to reprioritize if there is an increase in drug shortages or supply disruptions.

“It is difficult to speculate on what the exact impact will be on incoming submissions moving forward,” he said.

Hahn noted that drugmakers have begun to prioritize their drug submissions to help lighten review burdens on the agency.

The commissioner previously announced that all eligible FDA staff are working from home to adhere to social distancing policies during the outbreak. The telework policy does not apply to "non-portable" tasks like lab activities, he said. — James Miessler