September 16, 2026
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our nonprofit think tank has always supported the idea of user fees, but we’ve become increasingly concerned that CDER is agreeing to so many labor-intensive tasks on industry’s wish list every 5 years.
Like many of my colleagues, I spent hours attending the Stakeholder meetings. As patient groups, medical professionals, and public health experts, we represented a variety of viewpoints, but we all agreed that user fees should support the important mission of the FDA, which is ensuring safe and effective treatments. Some of us were more concerned about speed and flexibility than others, but nobody urged the FDA to prioritize speed of approval over the quality of the reviews or of FDA approval standards.
During the hours of meetings with the FDA, many of us repeatedly requested that PDUFA performance goals include metrics to evaluate the quality of evidence for approved drugs — and not just speed. After all our efforts, we read a Commitment letter that did not contain anything we asked for, and included many things that we did not want. We also read about programs that we hadn’t been told about and would have wanted to comment on. Even when the Commitment letter aims to improve transparency, it is for industry, not for the public. For example, if there are biannual updates for drug sponsors about Sentinel or any other program, why aren’t other Stakeholders invited? Why aren’t these meetings public? We may not be paying user fees, but as taxpayers we are paying for FDA salaries, and we’re paying for those drugs and for health insurance policies that cover them.
We wonder whether the FDA is still the gold standard for quality — not just speed — and how that will be tarnished by so many new, time-consuming requirements for FDA staff at a time when there are fewer staff, and when CDER has lost so many experienced scientists.
The public deserves better. And stakeholders deserve more than 2.5 minutes to share their views.