My “God help us…” comment was a broader comment and not related specifically to Neuren.
The impact of all this on Neuren?
Well, who can exactly predict what will happen, but let’s just say it’s not helpful.
If you follow the last link provided in my post, there are comments from insiders such as Janet Woodcock, ex-Commissioner of the FDA, and Frank Sasinowski, who joined the FDA in 1983 as regulatory counsel and helped establish several modern drug laws, such as the Orphan Drug law.
Woodcock says that the claim that the cuts at the FDA won’t impact drug reviews is a “naive conception.” She predicts that the targeted removal of health agency leaders will have catastrophic consequences for drug development, suggesting it will be a “slow-moving catastrophe”.
Sasinowski believes that the restructuring at the FDA will have a “disproportionate effect” on rare disease development.
Meanwhile, Scott Gottlieb, who served as FDA commissioner during the first Trump administration, shared his concerns, especially for rare diseases :
"Through a generation of congressional actions, investments in expertise and hiring, and careful policymaking, we built the FDA into the most efficient, forward-leaning drug regulatory agency in the world — and established the US as the global center of biopharmaceutical innovation."
However — referring to the "drug lag" of decades past when European patients received medical advances years before Americans — Gottlieb warned that "the cumulative barrage on that drug-discovery enterprise threatens to swiftly bring back those frustrating delays for American consumers, particularly affecting rare diseases.
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