The Trump administration is considering #Houman #Hemmati, an ophthalmologist, entrepreneur and frequent Fox News guest,
to serve as the nation’s next top regulator of #vaccines and treatments for complex diseases
If selected, Hemmati would replace #Vinay #Prasad, who is slated to leave the high-ranking position at the Food and Drug Administration at the end of April
after a rocky year.
Prasad had overseen controversial decisions about drugs and a new plan to tighten vaccine approvals, which drew condemnation from former agency leaders.
Prasad was briefly forced out last summer after just three months on the job.
He was reinstated less than two weeks later with the help of vaccine critic Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
Hemmati, if given the job, would arrive amid scrutiny from the White House on FDA operations.
Concerns over the agency’s direction mounted late last year as leadership turned over,
rattling the drug industry,
which relies on a predictable FDA to understand what it needs to do to win approvals for new treatments.
Hemmati has served in various industry roles,
including top medical positions at Optigo Biotherapeutics,
which focuses on treatments for neovascular and degenerative retinal diseases,
and Vyluma, a company developing eye drops.
He has worked as an adjunct clinical assistant professor at USC’s Keck School of Medicine, according to his LinkedIn profile.
Hemmati’s outspoken skepticism of the federal government’s response to the coronavirus pandemic helped win him fans,
including Makary and then-Stanford professor Jay Bhattacharya
— who now hold senior roles in the Trump administration.
Hemmati, who has said he was forced to flee Iran with his family as a child, also has supported President Donald Trump’s efforts for regime change in the country, expressing support for the American military in a TV appearance last month and on social media.
In 2023, Hemmati questioned why the federal government should be paying for more coronavirus vaccines.
He praised a new approach to the coronavirus vaccine that Prasad outlined last year, which narrowed approval for updated shots to older adults and people with at least one health condition. -- In past years, shots had been broadly recommended, including to children and generally healthy adults
FDA's Vinay Prasad, controversial CBER chief, to depart
https://misryoum.com/us/trending/fdas-vinay-prasad-controversial-cber-chief-to-depart/
WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration who has been at the center of recurring public controversies, is exiting the agency for a second time. Prasad will leave the FDA at the end of...
#FDAs #Vinay #Prasad #controversial #CBER #chief #depart #US_News_Hub #misryoum_com
The U.S. Food and Drug Administration is
refusing to consider Moderna’s application for a new flu vaccine
made with Nobel Prize-winning mRNA technology.
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.,
particularly those using mRNA technology,
which he has criticized before and after becoming the nation’s top health official.
Moderna received what’s called a “refusal-to-file” letter from the FDA
that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.
The letter from FDA vaccine director Dr. #Vinay #Prasad said the agency doesn’t consider the application to contain an
“adequate and well-controlled trial”
because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.”
Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen
— but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study.
Still, Moderna said, the FDA did agree to let the study proceed as originally planned
The company said it also had shared with FDA additional data from a separate trial
comparing the new vaccine against a licensed high-dose shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our product”
and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,”
Moderna CEO Stephane Bancel said in a statement.
https://apnews.com/article/moderna-vaccine-flu-mrna-2fc551cb2fb45735e67db0a4e2e2b0fb
The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA technology. The company announced the news on Tuesday. The FDA's decision reflects heightened scrutiny under Health Secretary Robert F. Kennedy Jr., who has criticized mRNA technology. Moderna received a “refusal-to-file” letter, objecting to its clinical trial methods. The FDA said the trial didn’t compare the new shot to the best available standard of care. Moderna has requested an urgent meeting with the FDA and noted it has applied for approval in Europe, Canada and Australia.
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Prasad’s arguments “misrepresent both the science and the regulatory record.”…
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#cdc #clinical-trials #covid-19 #fda #health #science #vaccines #vinay-prasad
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