Dr Vinay Prasad, the FDA's Chief Medical and Scientific Officer, resigned from his post on 29 July 2025 after mounting criticism over vaccine restrictions and a controversial gene therapy decision. The resignation, which was confirmed by the Department of Health and Human Services (HHS), came just months after Prasad's rapid rise within the federal agency.
According to officials, he will return to California to spend time with family, citing a desire 'not to be a distraction' to the FDA's work. His exit followed clashes over key regulatory decisions and growing pressure from political figures.
Who Is Vinay Prasad and Why Was He Appointed?
Dr Vinay Prasad is a haematologist-oncologist, epidemiologist, and academic known for his outspoken views on evidence-based medicine. With over 450 peer-reviewed publications, he gained prominence for his critiques of FDA drug approval processes and pandemic-era health policies.
In May 2025, Prasad was appointed Director of the FDA's Center for Biologics Evaluation and Research (CBER). Just weeks later, he was elevated to Chief Medical and Scientific Officer, serving as the top adviser to FDA Commissioner Marty Makary. His appointment was seen as an effort to tighten regulatory standards across vaccines, biologics, and gene therapies.
Vaccine Rulings Spark Internal and External Backlash
One of Prasad's most debated decisions came when he overruled internal FDA reviewers and restricted the use of Moderna and Novavax's updated COVID-19 vaccines, as reported by WVTM 13. Under his direction, the vaccines were authorised only for people aged 65 and older or those with weakened immune systems.
This ruling drew immediate concern from some within the agency and sparked criticism from political commentators who viewed the restriction as overly cautious. Critics argued that the policy undermined public health messaging and eroded confidence in FDA consistency.
Gene Therapy Controversy Adds to the Fallout
The scrutiny intensified following the FDA's handling of Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy. After reports of patient deaths, the FDA temporarily paused distribution of the treatment. However, according to a Reuters report, the agency reversed course and resumed authorisation shortly before Prasad's resignation.
The back-and-forth raised questions about internal coordination and risk communication. The reversal created confusion among physicians and families seeking clarity on treatment safety. While no direct blame was placed on Prasad, the incident added to the growing perception of instability under his scientific leadership.
Political and Ideological Pressures Mount
Prasad also became a lightning rod for political criticism. Right-leaning activists and commentators publicly accused him of holding progressive views that conflicted with the Trump administration's direction. Media figures including Laura Loomer labelled him a progressive leftist saboteur', while The Wall Street Journal published an editorial calling him 'a Bernie Sanders acolyte in MAHA drag'.
The ideological divide placed the FDA in a difficult position, as scientific caution clashed with political expectations.
Resignation Confirmed, Future of FDA Unclear
Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed Prasad's resignation. 'Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California to be with his family,' he said in a statement.
Commissioner Marty Makary has not yet announced a replacement.
