FDA cuts threaten medical product review programs

April 8, 2025

picture of the U.S. Food and Drug Administration sign

(Axios) – The upheaval at the Food and Drug Administration is threatening to cripple the user fee system that funds reviews of new drugs, devices and diagnostic tests, with the most immediate threat to look-alike biological drugs, according to four recently dismissed agency officials familiar with the process.

Why it matters: Drug and device manufacturers pump billions of dollars into the system to ensure their products get timely evaluations. The collapse of that process could return the FDA to the early 1990s, when patients faced long waits before they could access promising treatments and devices. (Read More)