FILE PHOTO: Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
A medical expert warned that the latest Trump administration cuts will prove to be a "significant setback for cell gene therapy."
Nicole Verdun, who headed the office that reviews cell and gene therapies at the Food and Drug Administration, was placed on administrative leave and escorted out of the agency along with her deputy Rachael Anatol, STAT reported Wednesday, citing a recording of a meeting.
Verdun had worked with, Peter Marks, the former head of the Center for Biologics Evaluation and Research, to create new pathways to bring gene therapies to market, particularly in rare diseases, according to the report. That former head was also previously ousted by the Trump administration.
Adam Feuerstein, one of the reporters who broke the news, noted on X that Verdun was viewed as an "essential regulator for cell and gene therapies by nearly every CEO I've spoken with since Marks was kicked out."
"This is really bad," he said.
Gene therapy modifies a person's genes to treat or cure diseases. Cell therapy transplants intact, living cells into patients to repair or replace damaged cells. The therapies, sometimes used together, aim to target the root causes of diseases, including genetic disorders, cancers and neurodegenerative conditions.
Verdun's unceremonious exit caught the attention of Dr. Scott Gottlieb, senior fellow at the nonpartisan American Enterprise Institute think tank.
"Along with loss of other senior FDA staff, this is a significant setback for cell gene therapy," he warned. "The advent of these advances was one of Pres Trump's first term triumphs, along with his efforts to expand access to them. The field now faces a harder future."
In a follow-up post, Gottlieb said the now-former FDA leaders had "deep subject matter expertise" and "knew how to make the pathway for these cell and gene therapies more viable."
"They have been doing hard work to pave the way for safe and effective advances to reach patients who could benefit from them," he wrote.