Key Takeaways
- Several managers in CBER's Office of Therapeutic Products have announced their departures as the Trump Administration continues the push to reduce the size of the federal workforce.
- Among those who will be leaving is Lola Fashoyin-Aje, who has worked on clinical trial diversity, accelerated approval and rare disease issues at the agency.
- The departures, and others expected, could undercut CBER efforts to better handle its cell and gene therapy workload.
Multiple leaders in the US Food and Drug Administration’s cell and gene therapy office are departing as the deadline for a decision on the buyout and early retirement offer looms.
Among those leaving the Center for Biologics Evaluation and Research’s Office of Therapeutic Products is Lola Fashoyin-Aje, director of the Office of Clinical Evaluation. Also leaving are Heather Lombardi, director of the Office of Cellular Therapy and Human Tissue CMC, Heather Erdman, associate director of quality assurance in the Office of Review Management and Regulatory Review, and Vaishali Popat, branch chief of General Medicine Branch 3 in the Office of Clinical Evaluation.
They join former CBER Deputy Director Celia Witten, who left the agency earlier this year.
The FDA did not respond to a request for comment.
More departures are expected. The Health and Human Services Department earlier this week offered a buyout payment, as well as eight weeks of pay and benefits, to FDA and other eligible staffers who chose to retire or resign.
HHS also has offered early retirement to staffers meeting age and service time requirements. The deadline for a decision to join both programs is 5 p.m. Eastern Standard Time 14 March.
The moves are intended to cut the size of the federal workforce. The Trump Administration, through its Department of Government Efficiency, laid off FDA workers in multiple centers and offices, but also rehired many of them.
Fashoyin-Aje Worked On Rare Disease, Trial Diversity Issues
Fashoyin-Aje is leaving on 28 March after tearfully announcing her departure during a 12 March meeting.
She moved to OTP from the Oncology Center of Excellence in February 2024 and was considered a rising star at the agency when she became head of the OTP general medicine, oncology and hematology application divisions.
Fashoyin-Aje was heavily involved in clinical trial diversity efforts and was the program lead for OCE’s Project Equity. When the FDA began more aggressively pushing clinical trial diversity, she spoke about the consequences of sponsors missing diversity goals and analyzed the FDA’s early experience with clinical trial diversity plans.
The Trump Administration’s efforts to remove diversity, equity and inclusion programs included taking down the FDA clinical trial diversity guidance and other webpages. The document was replaced following a court order, but the administration still made clear it rejected “gender ideology extremism."
She worked to improve the efficiency of evidence generation and offered tips to sponsors on confirmatory trials following accelerated approval while pathway reform efforts were ongoing.
Fashoyin-Aje also worked in rare disease drug development. She was among the reviewers that recommended against approving Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl), but was overruled by CBER Director Peter Marks.
Erdman advocated for the INTERACT program, which offers early meetings with CBER staff for sponsors in early development stages. In 2024, she said the meetings were not difficult to schedule if sponsors meet the criteria.
Departures Threaten Internal Improvements
The departing staff will be difficult to replace and may undercut efforts within CBER to better handle its cell and gene therapy workload.
The majority of the hiring authorized in the 2022 prescription drug user fee reauthorization was intended for CBER, including the cell and gene therapy program. The result was substantial growth, which included a reorganization to accommodate the larger cell and gene therapy staff.
Internal review processes also improved. After years of sponsor complaints about in-person meetings being converted to written response only format, OTP Director Nicole Verdun recently reported that sponsors have grown increasingly happy with written responses and not needed face-to-face sessions.
