Top FDA vaccine regulator abruptly exits post

Politico

30-07-2025

With help from Lauren Gardner
Driving the Day
A SURPRISE VACANCY — Dr. Vinay Prasad, the FDA's chief vaccine regulator, departed unexpectedly from his position on Tuesday, POLITICO's David Lim reports.
His departure follows recent accusations from conservative activist Laura Loomer that he was a progressive and not aligned with President Donald Trump's agenda. It also comes amid a dispute between the FDA and biopharmaceutical company Sarepta Therapeutics centering around Elevidys, a Duchenne muscular dystrophy treatment that Prasad had publicly criticized before his government service.
'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 and spend more time with his family,' HHS spokesperson Andrew Nixon said in a statement. 'We thank him for his service and the many important reforms he was able to achieve in his time at FDA.'
While at the agency, Prasad served as FDA Commissioner Marty Makary's right-hand, playing a prominent role in developing the Trump administration's approach to Covid-19 vaccine policy. He was the director of the Center for Biologics Evaluation and Research and also worked as the FDA's chief medical and scientific officer. Prasad could not be reached for comment Tuesday night.
Endpoints News and STAT previously reported the news of Prasad's departure.
Prasad, a frequent guest on Makary's FDA podcast, was scheduled to participate in another round of meetings with pharmaceutical and biotech chief executives in New York, Raleigh and Atlanta in the coming weeks with Makary and top drug regulator George Tidmarsh.
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At the Agencies
DIRECTING A CHANGING CDC — The Senate voted to confirm Susan Monarez as the next CDC director Tuesday, marking an end to the agency's four-month stint without a director or acting head and setting her up to helm an agency that's undergoing a rapid transformation.
Over the past several months, the Trump administration has rapidly changed the CDC, terminating thousands of its employees and upending some of its key functions, like the way the agency recommends vaccines.
Here are the biggest challenges Monarez will have to navigate over the coming months.
— The impact of the reduction in force: In April, around 2,400 CDC employees were told they would be terminated, including scientists, communications officials and entire offices — though a few hundred of those employees have since been rehired.
The administration is refocusing the CDC on infectious disease as it sheds much of its personnel working on chronic disease, occupational safety and health equity. The agency also absorbed some other agencies' work, including the Administration for Strategic Preparedness and Response.
Implementing those changes — many of which are still up in the air — will now fall to Monarez.
— Vaccine choices: In June, HHS Secretary Robert F. Kennedy Jr. overhauled the CDC's vaccine advisory panel, which votes on the immunizations that should be included in the agency's childhood and adult vaccine schedules. Kennedy fired the panel's 17 members and replaced them with eight new picks, with one withdrawing soon after their appointment. Several of Kennedy's choices have histories in the anti-vaccine movement, and the new panel has indicated it plans to revisit the childhood vaccine schedule.
Monarez will likely have to approve any changes made by the committee before they become official policy. It's customary for the CDC director to approve such changes, but Kennedy himself could continue to do so.
At her confirmation hearing in June, Monarez said she hasn't seen a causal link between vaccines and autism, though she dodged questions about whether she disagrees with any of Kennedy's moves.
— Communication challenges: Over her tenure, Monarez will need to find a way to effectively communicate with various sectors of the public who say they have lost trust in the CDC. That could prove especially challenging, as public health experts question Kennedy's influence over the agency and post-pandemic distrust lingers.
And some of the agency's key tools for communicating information to the public have also been impacted over the past few months — including the Morbidity and Mortality Weekly Report, the agency's flagship journal.
An analysis of the journal's recent publications by MedPage Today found that MMWR has published fewer articles over the past three months compared with the output over the same period in past years.
Eye on Insurers
A NEW ALZHEIMER'S APPROACH — Nonprofit health insurer EmblemHealth launched a first-of-its-kind lifestyle medicine program Tuesday for patients with early-stage Alzheimer's disease, Kelly reports.
The New York-based insurer announced it would cover the program, designed by preventive medicine researcher Dr. Dean Ornish and aimed at enhancing brain health and slowing disease progression through lifestyle modifications. Eligible enrollees who have mild cognitive impairment or early-stage dementia associated with Alzheimer's disease can enroll in the program for free.
Why it matters: The new initiative aligns with the Make America Healthy Again agenda that HHS Secretary Robert F. Kennedy Jr. has spearheaded, focusing on targeting the nation's chronic disease crisis through lifestyle habits like healthy eating and regular exercise.
It also comes as promising new Alzheimer's drugs have come to the market over the past few years, but some insurers have been reluctant to cover the treatments, given their steep price tag.
Background: The program offers biweekly online or in-person classes to provide patients with clinical, emotional and food support, according to a news release from EmblemHealth, which serves more than 2 million people in the New York tristate area and is one of the nation's largest not-for-profit insurers. The services offered include access to 'nutritious, whole food, plant-based meals and snacks' and guidance on preparing the foods at home, getting daily exercise and mitigating stress.
On Tuesday, Ornish announced results of a study he conducted on the program, where 26 people participated for 40 weeks and showed 46 percent improvement in 3 in 4 standardized tests — including measures of memory, judgment, problem-solving and in-home functionality. About 38 percent of the participants showed no decline, and 83 percent overall improved or maintained cognition.
'Partnering with a leading insurer such as EmblemHealth provides access to invaluable resources,' said Ornish, founder and president of the nonprofit Preventive Medicine Research Institute in Sausalito, California, in a news release. 'Bringing this program to seniors through a leading physician group and a mature community support system makes it possible to achieve groundbreaking results.'
In the courts
ALIGNING BEHIND PLANNED PARENTHOOD — Nearly two dozen Democratic-led states filed a lawsuit Tuesday challenging the GOP megabill's provision blocking Medicaid payments to Planned Parenthood affiliates, arguing that lawmakers are trying to force states to violate constitutional protections for free speech, Lauren reports.
The suit, filed in federal district court in Massachusetts and led by California Attorney General Rob Bonta, echoes the constitutional arguments Planned Parenthood made in its own challenge to the law, for which a federal judge granted an injunction Monday. The states say the statute — and Congress' and the Trump administration's records of disparaging the nonprofit's abortion-rights advocacy — violates the First Amendment and the Fourteenth Amendment's equal-protection guarantees against government retaliation.
The states also argue the provision violates the Constitution's prohibition of bills of attainder, a constitutional concept that blocks legislators from singling out entities for punishment without a trial.
'The President and Congress are implementing a cruel, backdoor abortion ban through this provision, putting their political agendas over people's lives,' Bonta said in a statement.
State-specific arguments: The Democratic states' lawyers contend that lawmakers 'conscripted' states into unconstitutionally targeting Planned Parenthood clinics. The law also saddles states with determining which entities with operations across state lines would have to be excluded from Medicaid payments, they said.
Why now? Judge Indira Talwani, an Obama appointee to the U.S. District Court in Massachusetts, granted Planned Parenthood's motion for a preliminary injunction Monday, putting the defunding provision on hold as the case moves through the courts.
The states acknowledged that development in their Tuesday statement but said they 'remain committed to ensuring full relief.'
Some Planned Parenthood clinics lost their Medicaid funding last week after a temporary restraining order expired on July 21, the same day Talwani granted a partial injunction that applied only to the few affiliates that wouldn't be subjected to the defunding provision because they don't provide abortions.
At the White House
PATIENT DATA PLEDGES — The White House and CMS are expected to announce today that roughly 60 entities in the health care sector will pledge to make patient data more accessible and speed its delivery among patients, clinicians and payers, according to an HHS employee granted anonymity to discuss the sensitive plans, POLITICO's Ruth Reader reports.
The agency hopes the commitments will stoke companies to make it easier for patients to import their data into an app of their choice, where they can manage their day-to-day health and easily share their history with doctors.
Pledges, not rules: The Trump administration has sought such commitments to compel the industry to make changes without having to engage in a lengthy rulemaking or guidance process.
But the federal government has tried similar tactics in the past.
In 2016, the then-secretary of the Department of Health and Human Services, Sylvia Burwell, under President Barack Obama announced at a health IT conference that dozens of health industry organizations would commit to easing the flow of health information to patients. Nearly 10 years later, those voluntary commitments haven't materialized into better data access.
Still, the Trump administration thinks it can appeal to the private sector more effectively.
Names in the News
Andi Lipstein Fristedt is now executive vice president, chief strategy and policy officer at the Parkinson's Foundation. She previously was deputy director and chief strategy officer at the CDC.
WHAT WE'RE READING
STAT's Chelsea Cirruzzo reports that HHS is vetting potential new members for the U.S. Preventive Services Task Force, the federal advisory panel that recommends which preventive services insurers must cover.