"Dr. Richard Pazdur, a longtime FDA official whom President Donald Trump's administration recently appointed to be the nation's top drug regulator, has warned that several fast-tracked initiatives to overhaul drug approvals pose a risk to public health. According to the Post, Pazdur, who was appointed on Nov. 11, has privately raised alarms about the legality and pace of FDA Commissioner Marty Makary's plans to dramatically accelerate drug-related decisions,"
"Pazdur has also questioned a separate Makary-championed drug-review program, embraced by the Trump administration as part of its push for lower drug prices and increased domestic manufacturing. The program allows the FDA to significantly shorten review times and expedite approvals for treatments tied to national health priorities, yet Pazdur has reportedly warned colleagues that it's not transparent enough and could be illegal."
Richard Pazdur, a senior FDA official recently appointed as the nation's top drug regulator, warned that several accelerated initiatives to overhaul drug approvals could risk public health. He privately raised concerns about the legality and pace of Commissioner Marty Makary's plans to speed drug-related decisions and proposals to reduce the number of studies required before approving label changes or other regulatory actions. Pazdur argued that multiple studies may be essential to safeguard patients. He questioned a Makary-backed expedited drug-review program for national priorities as insufficiently transparent and potentially illegal, and pushed back against sidelining career scientists on sensitive drug matters.
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