Controversial FDA vaccine regulator resigns for a second time

Vinay Prasad, the top vaccine regulator at FDA who has been at the center of some controversial decisions at the agency, will be leaving his position at the end of April, a spokesperson at HHS said on Friday.

Prasad is a former professor of epidemiology at the University of California, San Francisco (UCSF) and currently leads FDA's Center for Biologics Evaluation and Research (CBER), the center that oversees the regulation of vaccines, gene therapies, and the blood supply.

Prasad has been a vocal critic of FDA and CBER in the past and gained prominence in the 2010s as an online critic of precision oncology, arguing that a variety of expensive new cancer medications targeted to tumor mutations were eating up resources and providing little benefit to patients.

During his time at CBER, Prasad has been at the center of some controversial decisions made by FDA, including the refusal to accept Moderna's application for a new mRNA flu vaccine and FDA's decision to limit future access to COVID-19 vaccines — only allowing people ages 65 and older and those at high risk of complications related to the disease to get updated shots going forward.

In July, Prasad resigned from his position at CBER following a public campaign led against him by right-wing influencer Laura Loomer and lobbying by former Republican Senator Rick Santorum. However, Prasad was brought back at the insistence of both FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr.

In a post on X, Makary wrote that Prasad "got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month."

In an email to staff, Makary praised Prasad's efforts to identify promising drugs for speedy review, to allow for drug approvals after companies have completed one major study instead of two, and to update FDA's new COVID-19 vaccine framework.

"These reforms represented a tremendous body of work achieved in a remarkably short period of time," Makary wrote. "They are substantive, durable changes that will shape the agency's approach for years to come and stand as part of Vinay's lasting legacy here."

(Jewett, New York Times, 3/6; Lawrence, STAT, 3/6; Roubein, Washington Post, 3/6)

More than 50 medical schools pledge to back RFK Jr.'s framework for nutrition education

A group of 53 medical schools have pledged to increase the amount of time their students spend on nutrition education starting this fall after a monthslong campaign from HHS Secretary Robert F. Kennedy Jr. to get universities to accept the federal government's curriculum recommendations.

"I'm pleased to announce a transformative breakthrough in medical education," Kennedy said during an announcement on Thursday. "It will reshape the way that we train doctors in our country and deliver on President Trump's promise to end the chronic disease epidemic in America."

Kennedy added that part of the process had been "school-led" and that the announcement didn't represent "the Trump administration dictating" curriculum.

"We respect the independence of medical schools and accrediting bodies, and the Department of Education will never mandate curriculum — that's not our job," said Department of Education Secretary Linda McMahon. "But we can and will spotlight promising, evidence-based models; convene leaders who are improving health outcomes; and celebrate institution-driven curricular reforms."

As part of the initiative, the 53 medical schools across 31 states will require 40 hours of comprehensive nutrition education or competency equivalent before graduation, Kennedy said. "More than 30,000 physicians each year will now graduate equipped with nutrition education to help prevent, treat, and reverse chronic disease."

According to a fact sheet from HHS, the competency program includes 71 requirements for students to reach, including understanding "the principles of a balanced diet according to the new Dietary Guidelines for Americans," which was unveiled by the White House in January.

(Blinder, et al., New York Times, 3/5; Suter, The Hill, 3/5; Frieden, MedPage Today, 3/5)

Tim Hunt, CEO of the Alliance for Regenerative Medicine, said that he believes there's been a change at FDA "in the last few months" regarding the agency's stance on approving rare disease therapies.

"I think of it as a new, toxic ideology that has crept into the FDA, and it's having tragic consequences," he said.

A senior FDA official told Axios that was "absolutely not the case. There's no new mindset, there's no methodological purity," adding that FDA is "looking for the smallest possible spark. When we don't grant approval, it's usually because we don't even see the spark, let alone the fire, let alone the blaze."

On Monday, Johnson told Bloomberg that he plans to seek out copies of FDA's written denial letters to drugmakers and formally write to the agency to understand the reasoning behind their decisions.

"The stories are so outrageous," Johnson said. "It just appears that they're looking for excuses to say no."

(Feuerstein, STAT+ [subscription required], 3/3; Owens, Axios, 3/3; Laws, Newsweek, 3/10)

Oz says ACA enrollment numbers may be fraudulent

CMS Administrator Mehmet Oz told NBC News that enrollment in Affordable Care Act (ACA) plans is too high, suggesting that millions of people could be fraudulently enrolled or eligible for other types of coverage.

The most recent CMS data shows that around 23 million people signed up for ACA plans during this year's open enrollment, which ended in January — roughly 1.2 to 1.3 million fewer signups than last year.

Oz said that some people enrolled in ACA plans shouldn't have, and that he expects enrollment to drop to around 19 million.

"In fact, the fact that we have 23 million makes me think we have too many participants in the ACA," he said. "It's too high of a number."

Oz added that he believes some of ACA's enrollment could stem from fraud in the sign-up process, as well as cases where people were enrolled accidentally, were signed up for duplicate coverage, or received tax benefits they didn't qualify for.

"Either their income would not qualify them, they made too much or made too little, or they didn't file the forms, maybe on purpose, or they were duplicately enrolled in Medicaid or more likely other states' ACAs," he said. "These are major concerns for us."

(Lovelace Jr., NBC News, 3/9)