FDA Official Vinay Prasad To Exit As Trump Team Weighs Replacement##
Dr. Vinay Prasad, a controversial figure at the Food and Drug Administration who oversaw vaccines, will leave the agency at the end of April, according to a spokesman for the Department of Health and Human Services.
His departure follows a tenure marked by high-profile disputes over vaccine approvals, drug policy and the agency’s broader regulatory direction. As the FDA’s chief science and medical officer, Prasad held sweeping authority over vaccines, drugs and gene therapies.
He drew criticism from some inside the agency for overruling career scientists on certain vaccine decisions and for taking action against a biotech company linked to the deaths of two teenagers, The New York Times reported. Prasad, an oncologist, was an outspoken critic of U.S. drug and vaccine policies before joining the FDA, particularly opposing COVID-19 mandates.
Prasad’s Controversial Tenure at FDA
His views and public statements often put him at odds with elements of the scientific establishment even before he entered government service. During his time at the agency, Prasad was involved in a series of disputes over product reviews, including decisions tied to COVID-19 vaccines, gene therapies and treatments for rare diseases.
Those disagreements sometimes played out publicly, adding to scrutiny surrounding the FDA’s internal decision-making process.
Trump Administration Considers Replacement
The Trump administration is now considering Houman Hemmati to lead the FDA’s Center for Biologics Evaluation and Research, according to multiple media reports. Endpoints News first reported the development, and The Washington Post cited three people familiar with the matter who confirmed Hemmati is under consideration.
FDA Commissioner Marty Makary is said to favor Hemmati for the role, according to two of the people familiar with the discussions. However, a final decision has not been made, and officials emphasized that the vetting process is ongoing.
“No decision has been made on the selection of the next CBER director,” Andrew Nixon, a spokesman for the Department of Health and Human Services, said in a statement. “We continue to vet highly qualified candidates,” Nixon said.
Hemmati’s Background and Views
Hemmati has served in a number of industry roles, including senior medical positions at Optigo Biotherapeutics and Vyluma, companies focused on treatments for retinal and eye diseases. He has also worked as an adjunct clinical assistant professor at the University of Southern California’s Keck School of Medicine, according to his professional background.
In 2023, Hemmati publicly questioned why the federal government should continue paying for additional coronavirus vaccines. He also praised a revised vaccine strategy outlined by Prasad and Makary that narrowed approval for updated shots to older adults and people with underlying health conditions.
“This is REAL science, not political science,” Hemmati wrote on social media last year, referring to the updated approach to vaccine approvals. The policy marked a shift from earlier years when vaccines were broadly recommended across age groups, including for healthy adults and children.
Hemmati’s Policy Positions
Hemmati has also voiced support for several administration initiatives, including efforts led by Robert F. Kennedy Jr. to restrict purchases of soda and candy through federal food assistance programs. He has backed policies aimed at accelerating treatments for ultrarare genetic diseases through new regulatory pathways.
At the same time, Hemmati has encouraged vaccination for those at higher risk of serious illness. “For many people, the flu shot actually can be very beneficial,” he said during a January television appearance, adding that individuals should consult their doctors to determine what is appropriate for them.
Hemmati’s skepticism of the federal government’s pandemic response has earned him support from figures now serving in senior roles in the Trump administration. Those include Makary and Jay Bhattacharya, both of whom have taken positions aligned with a more limited federal role in public health mandates.
His potential appointment would come at a time of heightened scrutiny of the FDA from the White House and industry stakeholders. Leadership turnover in recent months has raised concerns among pharmaceutical companies that rely on a stable and predictable regulatory process for drug approvals.