FDA slows down on drug reviews, approvals amid Trump admin. chaos

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 of drug reviews and approvals, according to an analysis reported by Stat News.

An assessment of metrics by RBC Capital Markets analysts found that FDA drug approvals dropped 14 percentage points in the third quarter compared to the average of the six previous quarters—falling from an average of 87 percent to 73 percent this past quarter. In line with that finding, analysts noted that the delay rate in meeting deadlines for drug application reviews 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 relate to problems at manufacturing plants, which in turn could suggest problems with the FDA’s inspection and auditing processes.

With the government now in a shutdown—with no end in sight—things could get worse for the FDA. While the regulatory agency is still working on existing drug applications, it will not be able to accept new submissions.

“We see potential for greater dysfunction and short staffing compounding review timelines in the near term, potentially further exacerbated by continued leadership turnover and the now third-longest government shutdown,” the RBC analysts wrote in an investor note. The findings suggest a “risk we believe may not be fully appreciated given recent market highs.”

Overall, the analysts were optimistic that most pharmaceutical companies could weather the FDA’s dysfunction. But, cautioned that the data suggests it doesn’t seem like a short-term blip, the data “already suggest that the pattern of delays (in applications being evaluated) could persist.”

Earlier this year, the FDA lost 3,500 employees—about 19 percent of its staff—amid brutal cuts to the federal workforce, though some have since been rehired. Stat notes that about half of the agency’s senior leadership has left amid the Trump administration. During the shutdown, 14 percent of agency staff—over 2,000 staff members—are not working.