FDA Has the Wrong Mission. That’s Why It Fails.

Congress introduced legislation this month allowing seriously ill patients to access select treatments their physicians would prescribe – without FDA approval. That would mark a fundamental departure from the FDA’s total control over every prescription drug in America. That stranglehold is the efficacy mandate – the FDA’s requirement to certify that drugs work before any patient can access them, a federal override of the physician-patient relationship. Six center directors, two commissioners, thousands of departures since January 2025 – yet the FDA’s fundamental problem is not its leadership….
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