What accounts for this descent into cargo cult science? Much of the blame must go to the FDA’s reliance on industry paid user fees. Over the past three decades the proportion of the FDA’s annual drug budget made up of such fees has risen from less than 10% (fiscal year 1994) to more than two thirds (fiscal year 2023). In addition, the alluring “regulatory flexibilities” provided by the FDA Modernization Act of 1997 and the 21st Century Cures Act have become habit forming, enabling the FDA’s leadership and managers to deny scientific reality by defining effectiveness downward. In its quest to avoid difficult choices and hard decisions the FDA has increasingly embraced non-inferiority trials (or vice versa), ignoring the serious regulatory, clinical, and ethical problems caused by their misuse.However, the corruption of the FDA’s scientific culture remains the primary culprit driving the deterioration of safety and effectiveness standards. During my tenure at FDA, managers would admiringly speak of “crafting an approval,” as if it were a skilful demonstration of regulatory legerdemain rather than an act of scientific fabrication. The Recarbrio approval illustrates that the situation has, if anything, worsened since then. FDA leadership’s continued hostility towards meaningful peer review, transparency, and accountability dims the prospect for institutional self-renewal. So has the failure of much touted internal pathways for disagreement, which have amounted to little more than virtue signalling.
FDA scientists said that they couldn’t draw any inferences from the clinical trials for a new combination antibiotic from Merck—but the agency approved Recarbrio anyway. Peter Doshi investigates
