The head of vaccines and biologic medicines at the U.S. Food and Drug Administration (FDA) will step down from his position next month after several controversial regulatory decisions.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, is expected to leave the agency at the end of April, according to an FDA spokesperson.
The center is responsible for overseeing the approval and regulation of vaccines, gene therapies and other biological medicines in the United States.
Second Time Leaving the Role
This is the second time Prasad has stepped down from the position in less than a year.
He briefly left the role in July after criticism over some regulatory decisions but returned two weeks later in August.
After leaving the FDA in April, Prasad is expected to return to the University of California, San Francisco, where he previously worked before joining the agency.
Industry Concerns Over FDA Decisions
In recent months, the FDA has faced criticism from the biotechnology and pharmaceutical industries over several drug approval decisions.
Reports indicate that the agency rejected or discouraged approval applications for at least eight drug treatments.
Some companies said the FDA changed its guidance on the type of data needed for drug approvals, creating uncertainty for drug developers.
FDA Responds to Criticism
The FDA said it makes decisions based on scientific evidence and independent reviews.
An agency spokesperson said the FDA does not guarantee approval outcomes and must carefully evaluate the safety and effectiveness of new treatments.
Leadership Change Expected
FDA Commissioner Dr. Marty Makary said the agency will appoint a new leader for the biologics division.
Prasad’s departure comes as the FDA faces growing attention over its role in regulating vaccines and new medical treatments.
