Amid the chaos of the Trump administration's haphazard job cuts and a mass exodus of leadership, the Food and Drug Administration is experiencing a slowdown in drug reviews and approvals, according to an analysis reported by Stat News.
A review of the numbers by RBC Capital Markets analysts found that FDA drug approvals fell 14 percentage points in the third quarter compared to the average of the six previous quarters – from an average of 87 percent to 73 percent last quarter. In line with this finding, analysts noted that the delay rate in meeting drug application review deadlines rose from an average of 4 percent to 11 percent.
The FDA also rejected more applications than normal, going from a historical average of 10 percent to 15 percent in the third quarter. A growing number of rejections are linked to problems at manufacturing plants, which in turn could indicate problems with the FDA's inspection and audit processes.
With the government in a shutdown — and no end in sight — things could get even worse for the FDA. While the regulatory agency is still working on existing drug applications, it will not be able to accept new submissions.
