FDA caught up on domestic & foreign preapproval inspections

The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s Covid-19 pandemic restrictions.

So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug Law Institute’s (FDLI) annual meeting last week. Other priorities include accelerating the development of drugs to treat rare diseases, as well as spurring the use of real-world evidence (RWE) in clinical trials.

Despite the pandemic, the center has maintained historical trends in approving new drug and generic drugs, said Cavazzoni. Since last year’s FDLI conference, CDER approved 41 novel treatments in 2021, including 27 new drug applications (NDAs) and 14 biologics license applications (BLAs), with 23 of the 41 treatments indicated for rare diseases, Cavazzoni said. There were also 563 generic drugs approved during that time, and of these, 87 were first-time generic approvals and 56 were competitive generics.

Cavazzoni said that progress has also been made on the domestic front in inspecting sites awaiting product approval. “We are now in a position where all domestic preapproval inspections that had been delayed have been completed. Obviously, we used alternative tools” for some of these inspections, Cavazzoni said, adding that “there are always situations that we have no choice but to physically inspect the facility in order to make a decision on the applications.”

Yet this backlog has not yet been resolved when it comes to international facilities. Cavazzoni said that “all delayed CDER BLA inspections have been completed, with the exception of those in India and China. China remains a problem because of the ‘Zero Covid’ policy that exists in China which makes physical inspections exceedingly difficult, so these alternative tools will be particularly important at this juncture.” RAPS.org