Unforced errors flummox HHS’ radical transparency bid—again

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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.

Since his Senate confirmation hearing in February 2025, Robert F. Kennedy Jr. has pledged “radical transparency,” but the ethos at his Department of Health and Human Services has been anything but. In recent weeks, incidents at two HHS agencies underscore this problem.

On April 24, the FDA responded to President Donald Trump’s recent executive order to accelerate the development of psychedelic therapies by awarding Commissioner’s National Priority Vouchers (CNPVs) to three companies in the space. The agency did not, however, disclose the names of those recipients, and declined to do so when asked directly by BioSpace.

Meanwhile, at both the FDA and CDC, attempts to conceal information related to vaccines appear to be alive and well. On Tuesday, The New York Times reported that FDA officials have blocked the publication of several studies supporting the safety of vaccines against COVID-19 and shingles. This follows the revelation last month by The Washington Post that a study investigating the efficacy of the COVID-19 vaccine in preventing hospitalization will not be published. An HHS spokesman confirmed the decision to The Associated Press.

These are just the latest examples of what appears to be a clear lack of full disclosure from HHS. And for me, the agency’s failure to disclose its latest CNPV recipients was maybe the most egregious yet. The psychedelics space is small—we were going to figure it out. Best to just be upfront.

Secretive CNPV Selection

Following the FDA’s nameless psychedelics CNPVs, biopharma reporters—including myself—went on a hunt to determine the identity of the winners. The FDA did leave some breadcrumbs, including the type of psychedelic, the indication the drug was being developed for and a requirement that the product already hold the agency’s Breakthrough Therapy designation. This allowed us to cobble together a list of likely awardees.

One of our choices, Compass Pathways, issued a press release shortly after the FDA’s announcement, revealing itself as the winner of a priority voucher for psilocybin-based COMP360, in clinical trials for treatment-resistant depression. Our other two bets—Otsuka Pharmaceutical and Transcend Therapeutics’ methylone-based TSND- 201 for post-traumatic stress disorder and Usona Institute’s psilocybin-based candidate for major depressive disorder—were also guessed that afternoon by Psychedelic Alpha. Transcend has since confirmed its voucher in a press release.

Withholding such information undoubtedly flies in the face of the administration’s transparency push, especially considering the FDA has previously divulged the names of its CNPV recipients. First announced in June 2025, the CNPV program aims to shorten review times from 10–12 months to 1–2 months for investigational products that align with certain national priorities. Exactly four months later, the agency announced the first round of CNPV recipients—naming the products. The second batch of CNPV awardees was revealed in November, with, again, all six drugs being named. So why not this time?

“I can’t think of a reason why they wouldn’t have shared who it was,” Patrick Trucchio, an analyst at H.C. Wainwright who closely follows the psychedelics space, told BioSpace. It’s possible, Trucchio speculated, “they may not want to have an appearance of favoring certain companies over others.”

Controversy around the CNPV program is nothing new. In February, after the FDA allegedly failed to respond to several inquiries from Congress, Democratic representative Jake Auchincloss said in a letter to the agency that the pathway has been “shrouded in secrecy,” while regulatory experts have expressed confusion around the selection criteria for CNPV recipients.

FDA
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.

Censorship at FDA and CDC?

In the vaccine space, the apparent lack of transparency has been particularly challenging. Last September, former CDC Chief Medical Officer Debra Houry testified in front of Congress that she learned of changes to the CDC’s COVID-19 vaccine guidance for healthy children and pregnant women on an X social media post. This was a palpable demonstration of the absence of clear communication even within the agency, never mind straightforward explanations for such changes to the public.

During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.

Now, the administration appears to be censoring new science around vaccines. In the past two weeks, the withdrawal of vaccine-focused papers from both the FDA and CDC has come to light. In a statement to The New York Times regarding the FDA studies, HHS spokesperson Andrew Nixon said that “the studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.

“The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards,” Nixon continued.

But The Times had a different interpretation, arguing that the decision “is the latest step by the administration to try to limit access to vaccines.”

Over at the CDC, the decision not to publish appears to revolve around NIH Director Jay Bhattacharya’s concerns about the study’s methodology, according to The Post. As acting CDC director, Bhattacharya delayed publication of the paper, which had been set to appear in the CDC’s flagship scientific journal Morbidity and Mortality Weekly Report (MMWR) on March 19.

The study was later posted online by multiple individuals, including emergency physician Jeremy Faust. The results show that between September 2025 and December 2025, this year’s COVID-19 vaccines were 53–55% effective against hospitalization among non-immunocompromised adults.

It is “routine for CDC leadership to review and flag concerns about MMWR papers, especially relating to their methodology, leading up to planned publication,” HHS Spokesperson Andrew Nixon told The Post following the delay.

Bhattacharya doubled down on this point in an opinion piece published in The Washington Post on Thursday.

“The CDC director is responsible for ensuring that the agency’s methods reflect the best available science,” he wrote. Bhattacharya further noted that as MMWR papers are not subject to formal external peer review, he has called for the development of a peer-reviewed journal in addition to MMWR, “to complement it and elevate scientific rigor across all CDC publications.”

Scientific rigor is critical but wary researchers sounded the alarm. This isn’t the first time that HHS under Kennedy has appeared to censor its scientists, after all. Last May, NIH scientist Kevin Hall announced he was taking early retirement after the health department refused a media interview regarding his recent research into the connections between ultra-processed foods and chronic disease.

In a LinkedIn post, Hall wrote that he “experienced censorship in the reporting of our research because of agency concerns that it did not appear to fully support preconceived narratives of my agency’s leadership about ultra-processed food addiction.”

A balance problem

Transparency is a tricky concept. There are many legitimate reasons why the FDA may withhold information: to safeguard the privacy of trial participants or to protect sponsors’ proprietary information. But the pendulum can also swing in the opposite direction when decisions are not explained or clearly communicated.

In addition to these recent example, this was on full display in March, when FDA Commissioner Marty Makary revealed that controversial Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad would depart the agency at the end of April. Makary revealed at the time that this was always the plan—that Prasad was on a one-year leave of absence from his professor position at the University of California, San Francisco. This information, however, was never previously communicated to the industry or the public.

Stakeholders are clamoring for more transparency, from guidance around new policies like the one pivotal trial policy and the CNPV program to the actual process for selecting priority voucher awardees. Effective communication is a balancing act, and from a perception standpoint, the FDA appears to be struggling for equilibrium.

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Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
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