‘A Real Regulatory Dilemma Here’: What We Heard This Week

“It’s a real regulatory dilemma here.” — Donald Kohn, MD, of the University of California Los Angeles, at an FDA advisory committee meeting to discuss whether the bleeding reversal agent andexanet alfa (Andexxa) should get full approval.

“Less hateful, less political, and more just medical professionals talking about medical stuff.” — Nick Mark, MD, a critical care physician in Seattle, discussing the social media platform Bluesky.

“I have fantasized for years about abolishing clozapine REMS.” — Jacob Ballon, MD, MPH, of Stanford University in California, as an FDA advisory committee overwhelmingly voted to scrap the schizophrenia drug’s prescribing barriers.

“They need to be preventing illness … if they don’t do that, then they’re failing.” — Michelle Gutierrez Vo, RN, president of the California Nurses Association/National Nurses Organizing Committee, discussing how CDC advisors voted on guidelines for infection control in healthcare settings.

“We had to take action, because it appeared it was going to get much worse before it got better.” — Michael Barnett, MD, of Mass General Brigham, on why primary care doctors there want to unionize.

“[It’s] inevitable that the views that [Bhattacharya] had on pandemic response will influence how the NIH may approach any potential future pandemics.” — Milena Sullivan, MA, of the consulting firm Avalere, on Jay Bhattacharya, MD, PhD President-elect Donald Trump’s potential pick to lead the NIH.

“It confirms what we know, that all of the emphasis on early detection and screening has paid off.” — Ludmila De Faria, MD, of the American Psychiatric Association’s Council on Women’s Mental Health, discussing the rise in postpartum depression diagnoses over the past decade.

“Many of these medications could treat both asthma and their metabolic condition.” — Chloe Bloom, MSc, PhD, of Imperial College London, on the link between metformin and reduced asthma attacks in people with type 2 diabetes.

“The absolute risk of hospitalization of one out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults.” — Joshua Swan, PharmD, MPH, of Pfizer in New York City, discussing respiratory syncytial virus (RSV) hospitalizations during the past six seasons.

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