Drugs

Surge In FDA Drug Warning Letters Shows Structural Problem: Consultant

A 59% surge in FDA drug Warning Letters in 2025 over 2024 is not the result of isolated mistakes but rather “is the predictable outcome of a structural problem the industry has tolerated for too long.” That’s the view of Krieger Scientific founder and CEO Joseph Morwald, as expressed in a just-released news statement.

Morwald, whose consulting firm works in compliance and technical solutions, says the fact that FDA recommended outside compliance expertise in 87% of the 2025 Warning Letters “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.”

In a subsequent video release, Morwald says the drivers behind the surge in Warning Letters “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.”

He says that 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, he says, but the reality is they’re becoming less capable. Morwald says companies are 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome