Darwin's Our Take: Feature: A rare FDA refusal, CDC grant cuts, and proposed ACA exchange changes

In a relatively vapid week of health care news, federal agencies and lawmakers carried the headlines. Here are several of last week’s top stories out of D.C. ‍

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FDA refuses to review Moderna’s flu vaccine application

The FDA sent Moderna a refusal-to-file letter regarding the company’s Biologics License Application (BLA) for an investigational influenza vaccine made with mRNA technology.

The letter, signed by Dr. Vinay Prasad, director of the Center for Biologics Evaluation (CBER), stated that Moderna had not conducted an “adequate and well-controlled trial” to support the application, the company said Tuesday in a press release. The letter further stated that the FDA-approved comparator vaccine Moderna used in its Phase III efficacy trial “does not reflect the best-available standard of care.”  

According to Moderna, the company submitted its Phase III study protocol to CBER for review in April 2024.

In CBER’s response to the protocol submission, Moderna said, the agency agreed that “it would be acceptable to use a licensed standard-dose influenza vaccine as the comparator” but recommended that the company use a vaccine “preferentially recommended” for use in adults ages 65 and older by the Advisory Committee on Immunization Practices (ACIP). Doing so would help to inform ACIP’s recommendations on the vaccine’s use in that population, the agency noted.

CBER added that if Moderna were to proceed with a standard-dose flu vaccine comparator, “we agree with your plan to include statements in the Informed Consent Form.”

Moderna initiated the trial, which included more than 40,000 adults age 50 and older, in September 2024. By the end of the study, the investigational vaccine had met all agreed-upon, prespecified primary endpoints.

After a presubmission meeting in August 2025, CBER asked Moderna to include supportive analyses on the comparator vaccine in the BLA and said the data would be a “significant issue” during the application’s review. Moderna complied with the request, providing results from a separate Phase III trial that compared the investigational vaccine with a high-dose vaccine approved for use in older adults.

Moderna said CBER gave no indication before the company submitted the BLA that the agency would refuse to review it.

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” said Stephane Bancel, Moderna’s CEO.

In the refusal-to-file letter, Dr. Prasad told Moderna that 75% of the fee the company paid when it submitted the BLA would be refunded. If Moderna were to request that the BLA be “filed over protest,” he added, it would be considered a new original application and the company would be required to “remit the full fee or obtain a waiver.”

It’s rare for the FDA to issue a refusal-to-file letter, especially for any reason other than an incomplete submission. It’s also unusual for the company receiving the letter to make it public.

Analysts with TD Cowen stated in a note to investors that the letter “appears to deviate from historical review practices and seems unreasonably stringent, in our opinion.”

Dr. Peter Hotez, a professor at Baylor College of Medicine who’s an expert in global health and vaccinology, told CIDRAP News (an arm of the Center for Infectious Disease Research & Policy at the University of Minnesota) that the FDA had made “a commitment.” To “string Moderna along and all of a sudden say, nope, we’re not going to even review it” could undermine confidence in the FDA’s processes. He said the decision could have “an immediate chilling effect” — if regulatory expectations change late in the process, companies could begin to question whether the should invest in U.S.-based vaccine development.

Moderna said it has requested a meeting with CBER “to understand the basis for the refusal-to-file letter.

Meanwhile, Moderna noted, applications to approve the investigational vaccine have been accepted for review in the European Union, Canada, and Australia. The company also pointed out that many other countries do not preferentially recommend high-dose flu vaccines over standard-dose vaccines for older adults (which, presumably, could be why Moderna chose the comparator vaccine used in the main clinical trial instead of one CBER suggested).

The New York Times and other news outlets reported that Dr. Prasad overrode the recommendations of CBER staff, including career scientists, when he decided the agency would not review the BLA.

In an op-ed titled “Vinay Prasad’s Vaccine Kill Shot,” the Wall Street Journal’s editorial board criticized the decision. “It’s hard to recall a regulator who has done as much damage to medical innovation in as little time as Vinay Prasad,” they wrote, referring to the decision as “his latest drive-by shooting.”

“This is arbitrary government at its worst,” they added.  

The Times also reported that Dr. Marty Makary, commissioner of the FDA, talked about the decision during an interview on Wednesday, the day after Moderna issued its press release.

“Some say that the trial that [Moderna] conducted was unethical” because it did not offer the best control vaccine for older participants, Dr. Makary said. However, he also said the agency would continue to work with Moderna and the vaccine candidate might eventually be approved.

Under Health Secretary Robert Kennedy Jr., agencies within the Department of Health and Human Services have revised their stances on vaccines made with mRNA technology and have taken a stricter approach to vaccines in general.

Last April, Kennedy fired all ACIP members and subsequently replaced them with panel members who are more aligned with his views on vaccines. In May, HHS terminated a $590 million contract with Moderna to support late-stage development of an mRNA vaccine candidate for avian flu.

Also in May, Kennedy said he “couldn’t be more pleased to announce” that the Centers for Disease Control and Prevention had removed the COVID-19 vaccines from its recommended immunization schedule for healthy children and healthy pregnant women.

In August, HHS said it was “winding down” development of mRNA vaccines under the Biomedical Advanced Research and Development Authority (BARDA) and halted 22 projects involving approximately $500 million in contracts and funding.

Kennedy said at the time, “The data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”

In October, the CDC ended its universal recommendation for COVID-19 vaccines, and in January the agency eliminated certain vaccines from its recommended immunizations for children and adolescents.

Judge blocks CDC from cutting over $600 million in public health grants

The Hill reported that the White House Office of Management and Budget (OMB) sent a directive to the CDC on Feb. 5 ordering the agency to rescind $602 million in funding from California, Colorado, Illinois, and Minnesota — all states with Democratic governors.

The money would go toward state and local grants deemed too “woke” by the Trump administration, according to The Hill. An OMB spokesperson told the news outlet the rescissions are targeting “states fraught with waste and mismanagement” of taxpayer funds.

(The OMB directive also ordered the Department of Transportation to cancel $943 million in funding for the same four states.)

Becker’s Hospital Review reported that, according to an HHS spokesperson, the grants are being terminated because they “do not reflect agency priorities.”

According to Healthcare Dive, the grants would fund health-related concerns such as workforce initiatives; measures to prevent sexually transmitted diseases, including HIV; health equity proposals; and training for pediatric clinicians.

The rescissions would affect state public health departments and municipal agencies in Chicago, Denver, Minneapolis, and San Francisco, as well as universities and nonprofits, including the American Medical Association and the National Environmental Health Association.

On Wednesday, the attorneys general for all four states filed a lawsuit in Illinois against the Trump administration to prevent the proposed funding cuts, along with a motion for a temporary restraining order.

The judge issued a ruling on Thursday to keep the cuts from taking effect for 14 days, NPR reported, which will keep the funds “flowing” to their intended recipients while the court case proceeds.    

CMS proposes wide-ranging ACA marketplace changes

In a 577-page proposed rule issued on Monday, CMS revealed a lengthy list of changes it wants to make to standards for the Affordable Care Act exchanges for 2027, along with “provisions to improve implementation of the ACA.”  

Among the changes, CMS wants to expand access to catastrophic coverage and allow payers to offer catastrophic plans with terms as long as 10 years. The agency also wants to discontinue requirements that insurers on the exchanges offer standardized plan designs and eliminate the limit on the number of nonstandard plans insurers can offer.

Under the proposal, plans without any provider networks could be sold on the exchanges if they can ensure access to a sufficient range of providers.  

Other changes would have an impact on special enrollment periods, state-run exchanges, eligibility and income verifications, how plans are marketed, and, potentially, the federal medical loss ratio standard.

Public comments are being accepted through March 13.

House Republicans subpoena health insurers in probe of ACA subsidies fraud

Eight insurers have been subpoenaed by Republicans on the House Judiciary Committee in connection with an investigation into potential fraud centering on ACA premium subsidies.

The three Republican congressmen said in a press release that the insurers failed to comply with a voluntary document request sent in December. The request was made after auditors with the Government Accountability Office said they had obtained subsidized coverage for individuals who didn’t exist. The auditors identified other fraud risks as well, according to Axios.

Based on letters sent with the subpoenas, all of the insurers — Blue Shield of California, Centene, CVS Health, Elevance Health, GuideWell, Health Care Service Corp., Kaiser Permanente, and Oscar Health — responded to the December request, but their responses did not satisfy the committee chairman, Axios reported.

The subpoenas set a deadline of Feb. 23 for the insurers to submit the requested documents and information.

Senators introduce bill to break up ‘Big Medicine’

Sen. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., introduced legislation called The Break Up Big Medicine Act, which would prohibit health care “conglomerates” from owning companies that pay for health care services along with companies that set the prices for those health care services.

In other words, the same parent company could not own both a medical provider or management services organization (MSO) and a pharmacy benefit manager or insurer. The proposed bill would also prohibit the parent companies of prescription drug or medical device wholesalers from also owning a medical provider or MSO.

Companies in violation of the bill would need to come into compliance within a year.

Sen. Warren said in a press release, “The only way to make health care more affordable is to break up these health care conglomerates. Our bill would be a monumental step toward ending the stranglehold that corporate giants have on our broken health care system.”

What we’re reading

Medicare Advantage and Quality Measurement—A System at Risk. JAMA, 2.12.26 (registration or subscription may be required)

A System Built For Ordinary Times: Why US Vaccine Policy Fails When It Matters Most. Health Affairs, 2.13.26

Health Consequences of Immigration Enforcement in U.S. Communities. NEJM, 2.11.26 (registration or subscription may be required)