Why FDA is Sending an Increased Number of Drug Warning Letters

In July of this year, Krieger Scientific issued a release addressing the increase in 303 drug warning letters issued by FDA. In 2025, as new leadership took over the agency, FDA sent 303 drug warning letters, up 59% from the previous year.¹

Krieger’s founder and CEO Joseph Morwald believes that the increase is the result of structural problems within the industry. In his original statement, he said, “The FDA recommended outside compliance expertise in 87 percent of the warning letters it reviewed last year. That is not a coincidence. That is a diagnosis. When validation, calibration, and quality functions are managed in silos, by phase, by vendor, by department, with no single point of accountability, organizations lose the ability to catch problems before they become violations.”

Morwald spoke with Pharmaceutical Executive about the increase in warning letters and what he sees as the exact issues causing it. According to him, new technologies may be pushing companies away from human expertise, resulting in an increase in issues.

Pharmaceutical Executive: What is driving the increase of drug warning letters from FDA?
Joseph Morwald: The drivers behind what we're seeing are really a mixed bag. The industry is evolving very rapidly — the addition of AI tools, the shift in technology, the acceleration in drug approvals, and the change in experience levels at different levels within organizations all contribute to the factors driving today's compliance challenges.

In my opinion, one of the biggest drivers is that people are leaning more and more on AI and less on actual experience. It's easier to search for an answer than to actually know one. As a result, organizations are not utilizing the expertise of the generations before them, or even the experienced talent within their own organizations. AI is making people look smarter — but the reality is they're becoming less capable. We're relying less on actual intelligence and more on artificial intelligence, and that's showing up in warning letters and investigations that were produced without meaningful human review.

The FDA has identified this directly — it has made clear that there must be a human in the loop when reviewing, writing, creating, generating, and producing product. And that product can mean documentation, drugs, or vaccines. There is simply too much AI-generated material being produced without adequate human oversight, and we're increasingly relying on less experienced talent to do work that requires more experience.

Source

1. FDA Warning Letters Surge 59 Percent. One Life Sciences Firm Says the Industry Is Solving the Wrong Problem. Krieger Scientific. July 9, 2026. Accessed August 5, 2026. https://www.einpresswire.com/article/925352156/fda-warning-letters-surge-59-percent-one-life-sciences-firm-says-the-industry-is-solving-the-wrong-problem