The Food and Drug Administration (FDA) warned that its drug and device review may be affected by the COVID-19 pandemic.
The FDA said its Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) is working on both COVID-19 related matters while addressing its usual drug application review. The two centers are continuing to meet performance goals, approve applications and communicate with applicants.
But, the FDA noted, many staff are also juggling COVID-19 work as well, and if the pandemic continues that level of performance may not be able to continue indefinitely.
For medical devices, the Center for Devices and Radiological Health (CDRH) is in a similar situation. Many staff are working on COVID-19 matters and the center is still meeting its goals.
These potential delays to drug applications come after several years of increasingly speedy drug reviews. The FDA has been approving more drugs annually than ever.
A study from January 2020 examined these faster approvals and found that the FDA was relying on fewer or earlier-stage clinical trials than before to move more drugs through the approval process.
According to that study, the annual number of drugs approved rose from 34 between 1990 and 1999 to 41 between 2010 and 2018. But the drugs approved after pivotal trials dropped from 80% in 1995-1997 to 52% in 2015-2017.
So far, the pandemic has not affected drug review, the FDA said. But with the effects of the coronavirus extending into the summer and drug companies continuing to test new treatments for COVID-19 through the end of the year, the agency may have to adjust its work on drug approvals to focus on the virus.
“It is difficult to speculate on what the exact impact will be on incoming submissions moving forward,” the agency said in a statement. “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.”
For healthcare marketers, that could mean more waiting for drugs to hit the market and more delays on launch campaigns. Already, some pharma companies have delayed drug launches because of the coronavirus. The inability for sales reps to meet with doctors and for patients to see doctors to be prescribed are some of the issues these companies have cited.
The good news, for now, is that the FDA is still working on it and plans to prioritize its usual drug programs going forward.