As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed.

In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics. Rather than extend PDUFA and BsUFA dates across the board, the FDA will notify sponsors directly about their pending applications, according to the guidance.

The agency’s drug and biologics centers are both “experiencing considerable increases in COVID-19-related work, requiring shifting of staff resources to help with these activities,” the guidance said. In addition, staff who are members of the U.S. Public Health Service Commissioned Corps are being deployed to help in the emergency, further stretching the agency’s resources.

While the FDA will continue to try to meet its user fee goals, it said it anticipates having to allocate its resources to focus on pandemic activities. In the Office of New Drugs at the Center for Drug Evaluation and Research, as well as at the Center for Biologic Evaluation and Research, that focus will be on investigational new drug applications (INDs), new drug applications, and biologic and biosimilar license applications for products related to COVID-19 or certain other life-threatening conditions.

“Exceptions include the initial IND 30-day safety review and other important safety issues that may emerge during IND development,” according to the guidance.

Aside from inspections, the FDA is continuing most of its generic drug activities, but it said it is prioritizing the review of abbreviated new drug applications (ANDAs) that could help address COVID-19. In making that evaluation, the agency will consider whether an ANDA references a drug being investigated to treat or prevent COVID-19 or a drug labeled to treat or prevent secondary conditions associated with the coronavirus infection.

As more potential generic drug shortages develop, the agency may need to shift its generic drug resources to respond to those shortages, it said.

Meanwhile, the agency has converted all previously scheduled PDUFA and BsUFA meetings to virtual meetings and is conducting them on schedule. It also is continuing to accept, and grant, new meeting requests. However, “as circumstances warrant, we intend to re-evaluate the format of individual meetings that are still pending,” the agency said in the guidance.

In addition to virtual meetings with sponsors, the FDA is evaluating the feasibility of conducting advisory committee meetings virtually. “The review divisions will work closely with sponsors and applicants for specific applications that could potentially be affected and will discuss options for pursuing virtual meetings,” the FDA said.

Currently, no upcoming advisory committee meetings are listed on the agency’s calendar.

No Comments