FDA Commissioner Comments on Drug-Review Process in COVID-19 OutbreakBy
The US Food and Drug Administration (FDA) has provided an update as to its drug-review practices and timelines as specified through its user-fee programs in the wake of the novel coronavirus (COVID-19) outbreak.
With respect to drugs, the FDA has two user-fee programs: the Prescription Drug User Fee Act (PDUFA) provisions, under which the FDA collects user fees from drug manufacturers to fund the new drug approval process, and the Generic Drug User Fee Amendments (GDUFA), under which the FDA collects user fees for the generic-drug approval process.
The user fees collected under the PDUFA and GDUFA programs are used by the FDA to fund its activities in the drug-review and approval process. In turn, the FDA is required to meet certain performance goals, such as specific timelines for reviewing and approving drug applications.
“Throughout this public health emergency, we’ve continued to execute our review activities while responding to the public health needs of the current COVID-19 pandemic,” said FDA Commissioner Stephen M. Hahn, in an April 16, 2020 statement. “We continue to perform our user-fee review activities and our application review teams across the agency remain focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation. Part of these actions include looking at ways to use technology and established agreements with our foreign counterparts to minimize impact to applications under review.”
Hahn, however, acknowledged that due to changing resolution-allocation needs due to COVID-19, the agency may have to make future adjustments. “With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely,” said Hahn in the agency’s statement. “Our staffs are working at full capacity, and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.”
With respect to animal-drug and generic animal-drug user-fee programs, Hahn said that the FDA’s Center for Veterinary Medicine continues to meet all of its user fee-related performance goals and does not currently anticipate a change in its ability to meet these performance goals during the COVID-19 pandemic. “Our staff is currently in a primarily telework environment and is utilizing teleconferencing tools to continue communicating with sponsors in lieu of in-person meetings,” Hahn said in the statement. “To help minimize the potential impact of the COVID-19 pandemic on new animal- drug development, we issued guidance for industry stakeholders on the conduct and review of studies to support new animal-drug development. We are also closely monitoring the potential for new animal-drug shortages and supply-chain disruptions, and we are working closely with sponsors to address these challenges, as appropriate.”
Overall, for all drug reviews and related processes, Hahn added that “it is difficult to speculate on what the exact impact will be on incoming submissions moving forward. We are seeing and hearing from industry that companies are taking a role as partners in the defense of the public health by prioritizing their work and submissions.”
Source: US Food and Drug Administration