FDA’s New Drug Approval Pathway Raises Questions About Oversight and Patient Safety

The Food and Drug Administration recently unveiled a proposal aiming to accelerate the approval of personalized treatments for rare genetic diseases—conditions traditionally ignored by big pharma due to limited profitability. While this move might appear to prioritize innovation, it actually signals a troubling departure from proven regulatory safeguards designed to protect American families. Are We Lowering the Bar at the Expense of Patient Protection? The FDA’s new "plausible mechanism" pathway would allow experimental therapies tested on only a handful of patients to progress toward commercialization, sidestepping the robust clinical trials long held as gold standard in drug approval. This shift...