The recent wave of high-level departures at the FDA – covered recently by biotech media, including Endpoints – marks a significant shift in the regulatory landscape. Historically, FDA decisions have been rooted in rigorous, data-driven processes, providing a degree of predictability for biotech companies planning years in advance. Now, with these departures, we face an unfamiliar and unpredictable dimension of regulatory risk.

This uncertainty is deeply concerning for an industry that relies on stable and transparent regulatory frameworks to guide innovation and investment. Will the FDA retain the capacity to evaluate drug applications with the rigor and objectivity that have long been its hallmark?

To those who have criticized the FDA’s processes in the past, I would urge caution. A robust, science-based regulatory agency is not just essential for our industry—it is vital for public health.