FDA Approving Novel Drugs at Same Rate Despite Pandemic; PDUFA Picture Unclear

The COVID-19 pandemic does not appear to be slowing down the rate at which the FDA is approving novel drugs, although there is anecdotal evidence that it is causing the agency to miss some deadlines for approvals under the Prescription Drug User Fee Act (PDUFA).

According to the FDA Center for Drug Evaluation and Research (CDER)’s web page for novel drug approvals, which includes new molecular entities (drugs) and new therapeutic biological products, CDER completed 38 approvals between the beginning of the pandemic “lockdowns” in mid-March and Monday, exactly the same number that it approved in the corresponding period of 2019.

The picture for PDUFA VI performance won’t be known until the agency submits to Congress its fiscal 2020 report, which will cover a one-year period ended Sept. 30. But some drug companies have announced over the past year that the agency has let them know it can’t meet its deadlines under the law due to the pandemic.

Notably, on Nov. 16, Bristol-Myers Squibb (BMS) said the FDA had let it know that its review of the Biologics License Application for lisocabtagene maraleucel (liso-cel) for large B-cell lymphoma was not going to be complete on that date as previously expected (DID, May 7). The reason: because the agency “was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic,” BMS said.

“The FDA is deferring action on the application until the inspection can be completed,” BMS added. “The application remains under review. The FDA did not provide a new anticipated action date.”

When asked for comment on how the pandemic is affecting approval schedules, an agency spokesperson pointed to a June 23 statement by FDA Commissioner Stephen Hahn.  “We are currently on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90 percent of brand, generic and biosimilar drug applications even during the pandemic,” Hahn said. — Martin Berman-Gorvine