FDA Reports Increase in Novel Drug Approvals in 2020

FDA Headquarters

The U.S. Food and Drug Administration (FDA) is taking a look in the mirror as the new year gets under way, and is liking most of what it sees.

Working through the challenging conditions of the COVID-19 pandemic, the agency reports it managed to approve 53 novel drugs in 2020. That’s five more than in 2019, when FDA reported 48 approvals.

While 2020 saw fewer novel approvals than the 59 okayed in 2018, last year’s tally topped the results from 2017, 2016, and 2015, which saw 46, 22, and 45 approvals, respectively.

In 2020, the agency issued 613 Warning Letters, including ones given to device, food, and tobacco companies, compared to a total of 480 in 2019. FDA analysts speculate the spike may have come from a wave of warnings sent to companies allegedly involved in COVID-19 scams and/or other fraudulent marketing activities.

Edited by Michael Causey