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FDA cautions that drug reviews will be slower due to COVID-19

Published on 17/04/20 at 12:30pm

The FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals of marketing applications due to staff being reallocated to working on the COVID-19 coronavirus pandemic.

In a statement on its website, the regulatory body said: “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. 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.”

“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.

“As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible as we work to address the COVID-19 pandemic, as well as keep other key mission-critical initiatives unrelated to the pandemic moving forward.”

This has already affected the approval pipeline for drugs from large pharmaceutical companies. In late March, Bristol-Myers Squibb had its multiple sclerosis drug, Zeposia, approved. But its actual launch was delayed due to coronavirus drawing attention away from the regulatory process.

The regulatory process for drugs is not the only area being affected, with clinical trials being affected by delays and suspensions. Eli Lilly said it will delay its clinical trials, and it currently sponsors 86 trials including 30 that are in Phase 3.

Conor Kavanagh

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