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Rachel V Thomas

US FDA Vaccines Chief Vinay Prasad Exits Again After Criticism Over Drug Application Handling

The US Food and Drug Administration (FDA)’s Vinay Prasad has once again — for the second time in less than a year — stepped down from his post as director of the agency’s Center for Biologics Evaluation and Research, amid controversies over the review of vaccines and specialty drugs for rare diseases.

Announcing the news to FDA staff in an email late Friday, FDA Commissioner Marty Makary said Prasad would depart at the end of April. Makary added that Prasad would return to his academic position at the University of California, San Francisco (UCSF).

Taking to social media platform X, Makary said that under Prasad’s leadership, his center recorded a record number of approvals in December.

“A year ago, Dr. Prasad came to the FDA to implement four major long-lasting reforms: a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified COVID vaccine framework, and the new plausible mechanism framework for ultra-rare diseases, which we launched last week,” Makary said.

The FDA commissioner noted that Prasad “got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning to his academic home later next month,” and thanked him “for his service and personal sacrifice in taking time away from his family.”

The FDA is expected to announce Prasad’s successor before his departure.

Vinay Prasad is an Indian-origin American hematologist-oncologist and author. He was first appointed as the FDA’s vaccines chief in May 2025.

Prasad, known as a longtime critic of the FDA’s standards for drug reviews, drew controversy for raising the bar for new drug approvals. The move did not sit well with pharmaceutical companies and reportedly dashed the hopes of some patients with rare diseases.

In July, he was removed from his position following disputes with biotechnology executives, patient organisations, and conservative allies of US President Donald Trump. He was later reinstated after Makary and US Health Secretary Robert F. Kennedy Jr. pushed for reconsideration.

While Prasad, along with Makary, announced several measures to make FDA drug reviews faster and easier for companies, he also imposed new warnings and study requirements for some biotech drugs and vaccines.

This was particularly evident in the case of COVID-19 vaccines, which have been a target of criticism from Kennedy, who was a longtime anti-vaccine activist before joining the Trump administration.

The latest controversy involves the FDA’s interactions with Dutch biopharma company uniQure, which developed an experimental gene therapy for Huntington’s disease that is injected directly into the brain during a surgical procedure.

Huntington’s is a deadly neurological condition affecting about 40,000 Americans, and currently has no cure.

UniQure faced a setback after Prasad’s centre said its earlier studies were insufficient to support a biologics licence application.

During an earnings call earlier this week, the company said the FDA was demanding a new trial involving sham surgery for some patients.

Executives said the request for a sham-controlled trial contradicted earlier FDA guidance. They also questioned whether such an approach would be ethical for patients with Huntington’s disease, which is progressive and ultimately fatal, typically in middle age.

Earlier, Prasad also refused to allow the FDA to review a highly anticipated flu vaccine from Moderna made using mRNA technology.

The rejection of the application -- highly unusual for the FDA -- prompted Moderna to go public with Prasad’s decision and vow to formally challenge it.

A week after the rejection became public, the FDA reversed course and said it would accept the vaccine for review, pending an additional study from the company.

Prasad’s handling of rare-disease therapy applications also drew criticism after the FDA asked Sarepta Therapeutics, a drugmaker developing treatments for Duchenne muscular dystrophy, to pause shipments following reports of patient deaths.

The company initially resisted, wanting to continue distributing treatments for patients who could still walk, but later agreed. The agency, however, reversed the pause just days later.

Duchenne muscular dystrophy affects a small number of boys and young men who typically lose their ability to walk before puberty and often die by around age 30.

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The US Food and Drug Administration (FDA)’s Vinay Prasad has once again — for the second time in less than a year — stepped down from his post as director of the agency’s Center for Biologics Evaluation and Research, amid controversies over the review of vaccines and specialty drugs for rare diseases.Announcing the news to FDA staff in an email late Friday, FDA Commissioner Marty Makary said Prasad would depart at the end of April. Makary added that Prasad would return to his academic position at the University of California, San Francisco (UCSF).Taking to social media platform X, Makary said that under Prasad’s leadership, his center recorded a record number of approvals in December.“A year ago, Dr. Prasad came to the FDA to implement four major long-lasting reforms: a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified COVID vaccine framework, and the new plausible mechanism framework for ultra-rare diseases, which we launched last week,” Makary said.The FDA commissioner noted that Prasad “got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning to his academic home later next month,” and thanked him “for his service and personal sacrifice in taking time away from his family.”The FDA is expected to announce Prasad’s successor before his departure.Who Is Vinay Prasad?Vinay Prasad is an Indian-origin American hematologist-oncologist and author. He was first appointed as the FDA’s vaccines chief in May 2025.Prasad, known as a longtime critic of the FDA’s standards for drug reviews, drew controversy for raising the bar for new drug approvals. The move did not sit well with pharmaceutical companies and reportedly dashed the hopes of some patients with rare diseases.In July, he was removed from his position following disputes with biotechnology executives, patient organisations, and conservative allies of US President Donald Trump. He was later reinstated after Makary and US Health Secretary Robert F. Kennedy Jr. pushed for reconsideration.What Is The Controversy?While Prasad, along with Makary, announced several measures to make FDA drug reviews faster and easier for companies, he also imposed new warnings and study requirements for some biotech drugs and vaccines.This was particularly evident in the case of COVID-19 vaccines, which have been a target of criticism from Kennedy, who was a longtime anti-vaccine activist before joining the Trump administration.The latest controversy involves the FDA’s interactions with Dutch biopharma company uniQure, which developed an experimental gene therapy for Huntington’s disease that is injected directly into the brain during a surgical procedure.Huntington’s is a deadly neurological condition affecting about 40,000 Americans, and currently has no cure.UniQure faced a setback after Prasad’s centre said its earlier studies were insufficient to support a biologics licence application.During an earnings call earlier this week, the company said the FDA was demanding a new trial involving sham surgery for some patients.Executives said the request for a sham-controlled trial contradicted earlier FDA guidance. They also questioned whether such an approach would be ethical for patients with Huntington’s disease, which is progressive and ultimately fatal, typically in middle age.Earlier, Prasad also refused to allow the FDA to review a highly anticipated flu vaccine from Moderna made using mRNA technology.The rejection of the application -- highly unusual for the FDA -- prompted Moderna to go public with Prasad’s decision and vow to formally challenge it.A week after the rejection became public, the FDA reversed course and said it would accept the vaccine for review, pending an additional study from the company.Prasad’s handling of rare-disease therapy applications also drew criticism after the FDA asked Sarepta Therapeutics, a drugmaker developing treatments for Duchenne muscular dystrophy, to pause shipments following reports of patient deaths.The company initially resisted, wanting to continue distributing treatments for patients who could still walk, but later agreed. The agency, however, reversed the pause just days later.Duchenne muscular dystrophy affects a small number of boys and young men who typically lose their ability to walk before puberty and often die by around age 30.