Trump administration's embattled FDA vaccine chief is leaving for the
second time
[March 07, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration’s embattled vaccine
chief, Dr. Vinay Prasad, is once again leaving the agency — the second
time in less than a year that he’s departed after controversial
decisions involving the review of vaccinations and specialty drugs for
rare diseases.
FDA Commissioner Marty Makary announced the news to FDA staff in an
email late Friday, saying Prasad would depart at the end of April.
Makary said Prasad would return to his academic job at the University of
California, San Francisco.
In July, Prasad was briefly forced from his job after running afoul of
biotech executives, patient groups and conservative allies of President
Donald Trump. He was reinstated less than two weeks later with the
backing of Health Secretary Robert F. Kennedy Jr. and Makary.
Prasad’s latest ouster follows a string of high-profile controversies
involving the FDA’s review of vaccines, gene therapies and biotech drugs
in which companies have criticized the agency for reversing itself, in
some cases calling for new trials of products previously greenlighted by
regulators.
In the last month, Prasad has come under fire from pharmaceutical
executives, investors, members of Congress and other critics for
multiple decisions at the agency.
First, Prasad initially refused to allow the FDA to review a highly
anticipated flu vaccine from drugmaker Moderna made with 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 shot for review after all, pending an
additional study from Moderna.
Then, in the past week, the FDA engaged in a highly unusual public fight
with a small drug company developing an experimental treatment for
Huntington’s Disease, a fatal condition that affects about 40,000 people
in the U.S.
The company, UniQure, said Monday that the FDA was demanding a new trial
of its gene therapy that would involve performing a sham surgery on some
of the patients in the trial. The company’s gene therapy is injected
directly into the brain during a surgical procedure.
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 Company executives said the request
for a sham-controlled trial contradicted previous FDA guidance and
raised ethical concerns for patients.
On Thursday, the FDA held a highly unusual press conference with
reporters to criticize the company’s therapy and defend the agency's
request for an additional study.
A senior FDA official, who requested anonymity to speak with
reporters, called the company’s original study “stone cold
negative.”
“We have a failed product here,” he added.
The FDA typically communicates in carefully-vetted written
statements when speaking about scientific disagreements, especially
those involving experimental drugs that are still under the agency’s
review.
Prasad’s time as the FDA’s top vaccine and biotech regulator has
been marked by a series of similar disputes with the companies the
agency regulates.
More than a half-dozen drugmakers studying therapies for rare or
hard-to-treat diseases have received rejection letters or requests
to run additional studies, adding years and potentially many
millions of dollars to their development plans.
A longtime academic and critic of the FDA’s standards for drug
reviews, Prasad’s approach to regulation since arriving at the FDA
last May has confounded many FDA observers and critics.
On repeated occasions, Prasad joined Makary in announcing steps to
make FDA drug reviews faster and easier for companies. But he also
has imposed new warnings and study requirements for some biotech
drugs and vaccines, particularly COVID shots that have long been a
target for Kennedy, a longtime anti-vaccine activist before joining
the Trump administration.
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