Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. This week's updates are as follows:
- Changes in the Center for Drug Evaluation and Research (CDER) Leadership
- Key Leaders in the Office of Therapeutic Products (OTP) Placed on Administrative Leave
- FDA Considers Reforms to Expedite Drug Development Amid Global Competition
Changes in CDER Leadership
During the past few weeks, there have been significant developments regarding CDER leadership. According to several reports, the acting director of CDER, Dr. Jacqueline Corrigan-Curay, J.D., M.D., intends to retire from the FDA in July. At this time, there has been no official announcement of who will replace Dr. Corrigan-Curay. BioCentury reports that Karim Mikhail, whose professional background includes executive roles in the pharmaceutical industry, is a potential candidate. Mikhail currently serves as a senior adviser in the Office of the Commissioner.
While we await an announcement regarding the next CDER Director, it has been reported that Dr. Mike Davis, M.D., Ph.D., will serve as deputy director. Davis's background includes roles in CDER's Office of Neuroscience – Division of Psychiatry as a clinical reviewer and a clinical team leader. Before returning to the FDA, Dr. Davis was the chief medical officer at a psychedelic medicine research organization.
Key CBER OTP Leaders Placed on Administrative Leave
Similar leadership developments have also occurred at the Center for Biologics Evaluation and Research (CBER). According to STAT News, two top officials in CBER's Office of Therapeutic Products (OTP) were recently placed on administrative leave. Before being placed on leave, Dr. Nicole Verdun, M.D., served as OTP's director, while Rachael Anatol, Ph.D., served as deputy director. OTP "oversees development for a wide variety of biological products, including gene and cell therapies, tissues and tissue-engineered products, xenotransplantation products, and more." Dr. Vijay Kumar, M.D., M.M.M., is now the acting director of OTP, according to reports. Additionally, Inside Health Policy reports that CBER Director Dr. Vinay Prasad, M.D., M.P.H., has also been named the Agency's chief medical and scientific officer.
FDA Considers Reforms to Expedite Drug Development Amid Global Competition
Endpoints News reported that during a CEO Forums meeting in Boston, FDA leaders acknowledged growing concerns over the U.S. being outpaced by countries like China and Australia in early-phase drug development. CBER Director Dr. Prasad mentioned that the U.S. trails Australia in Phase 1 study launches, while executives proposed streamlining investigational review boards to remove barriers. Discussions also highlighted industry calls for faster reviews, improved data sharing, and AI-driven efficiencies, with FDA officials signaling openness to reform.
In related news, the Agency recently announced its Commissioner's National Priority Voucher (CNPV) program, which aims to accelerate drug application reviews by having reviews completed 1–2 months after submission. How the recent leadership changes will impact FDA's push for faster drug reviews—and whether they signal a broader shift in regulatory focus—remains to be seen.
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions on how the contents of this article may impact you or your business's interactions with the FDA, please contact the authors today.