FDA Announcements Spark Vigorous Debate, Controversy

The U.S. Food and Drug Administration is often described as the most influential scientific regulator in the world. Its decisions shape global drug development, investment, and patient access. But in recent weeks, the agency has undergone one of the most tumultuous periods in its modern history. A cascade of announcements and internal leaks has generated a storm of controversy, culminating in the abrupt retirement of Richard Pazdur , one of the FDA’s most respected leaders.

At the center of the upheaval are sweeping reforms announced by FDA Commissioner Marty Makary, a leaked memo from the agency’s top vaccine regulator Dr. Vinay Prasad, a new proposed approval pathway for bespoke therapies, and a rare, forceful public rebuke from former FDA commissioners. Together, these