Biology vs. Bullsh*t at the FDA

“In the long contest between biology and bullshit, biology is undefeated,” Auchincloss [told Bloomberg]. “The [FDA] commissioner is trying to wage that battle, and it’s going to be patients who lose.”

The Food & Drug Administration (FDA) is staffed by scientists who review evidence to determine the safety and efficacy of medicines. It’s a bureaucracy wrestling with biology, so of course it’s messy. But in general, they have done well. Away from the political spotlight, the FDA sifted through randomized controlled trials and debated surrogate endpoints with investigators. It became the world’s gold standard biomedical regulator.

Until 2025. Then, the bullshit started. A crew of anti-vax zealots, bio-hackers, and wellness grifters descended on the Department of Health & Human Services. Now, measles is breaking out; AI slop is replacing scientific review; the scientist who ensures your eye drops don’t blind you was fired; and the wealthy receive tax breaks for buying bidets.

The GOP is too afraid of RFK. Jr to hold a hearing. Big Pharma is rushing to the White House to cut pricing deals, averting its eyes from the FDA en route. While industry caves and Republicans shrug, the FDA has hemorrhaged competence and credibility. A former commissioner — who served in a Republican Administration — told me the FDA had lost 20 years in the last one.

https://www.meidasplus.com/p/biology-vs-bullsht-at-the-fda