At President Donald Trump’s direction, the Food and Drug Administration plans to toughen oversight of prescription drug advertising, announcing plans Tuesday to “aggressively deploy its available enforcement tools.”

In a statement, the FDA said it is sending “thousands” of letters to drugmakers demanding they take down any noncompliant ads or bring them into compliance. The statement links to a form letter addressed “Dear Pharmaceutical Company.” The agency said it also is issuing around 100 cease-and-desist letters to companies with ads it has judged to be deceptive. No specific companies were named, however.

The FDA’s actions are in response to an executive order issued by Trump on Tuesday. “The FDA has historically stipulated that a manufacturer, packer, or distributor must provide the public with materially complete information that fairly balances both the benefits and the risks of the drug,” the order states. “Over time, however, the FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising.”

The order alludes to a requirement known as “adequate provision” that was introduced for drug ads in 1997. Under this framework, companies can pair disclosure of a drug’s major risks with a statement pointing consumers to sources where they can obtain more complete information.

In its statement, the FDA said it has grown concerned consumers are no longer seeing a “fair balance” of risks and benefits in drug ads, particularly in digital and social media channels. Going forward, the regulator said it would use “AI and other tech-enabled tools to proactively surveil and review drug ads.”

Trump tried to rein in pharma advertising in his first term, proposing a rule drugmakers include prices in their marketing materials. Several drugmakers sued, however, and successfully got the rule struck down in court. — Ned Pagliarulo

HHS said it has removed Susan Monarez as director of the Centers for Disease Control and Prevention, a post for which she was confirmed by the Senate a month ago. Monarez’s attorney claimed the firing was invalid because, as Monarez is a presidential appointee, the decision to fire her must come from President Donald Trump.

Monarez’s attorney, Mark Zaid, said Monarez “refused to rubber stamp unscientific, reckless directives and fire dedicated health experts,” leading HHS Secretary Robert F. Kennedy to try to push her out.

Per reporting by Inside Medicine, the termination order prompted resignations of three other top CDC officials: Debra Houry, chief science officer; Demetre Daskalakis, immunization and respiratory diseases director; and Daniel Jernigan, emerging and zoonotic infectious diseases director.

On Thursday, the CDC website was updated to list their roles and the director’s post as “vacant.” 

Following the announcements, Sen. Bill Cassidy, R-La., chair of the Senate Health, Education, Labor and Pensions Committee, stated on X, “These high profile departures will require oversight by the HELP Committee.”

The attempted ouster follows an attack by a gunman on the CDC headquarters in Georgia that resulted in the death of a police officer and at least 180 shots fired at workers inside. A letter sent last week to Kennedy, signed by HHS public health officials, criticized Kennedy for sowing the distrust in their agencies that led to the attack. “When the federal workforce is not safe, America is not safe,” the letter read. — Jonathan Gardner

The Senate on Tuesday confirmed by a 51-47 party-line vote Susan Monarez as the next director of the Centers for Disease Control and Prevention.

Monarez’s confirmation ends uncertainty about authority at the CDC, which had no formal acting head while she awaited confirmation.

She had served as acting director from January through March. After a previous nominee to head CDC, former Rep. Dave Weldon, was withdrawn before confirmation, President Donald Trump nominated her to head the agency, which required her to step down as its acting head.

In the interim, decisions and recommendations made by the CDC and its advisory committees have been signed by HHS Secretary Robert F. Kennedy Jr., who has questioned established science on vaccines and other public health issues.

Monarez will lead an agency that has been hit hard by budget and staffing cuts. She also may be under pressure from Kennedy due to the CDC’s role in recommending public health measures such as vaccines and other strategies for combating infectious diseases.

Monarez holds a doctorate in microbiology and immunology from the University of Wisconsin and did post-doctoral studies at Stanford University. Before CDC, she served at the Advanced Research Projects Agency for Health and in health roles at the White House Office of Science and Technology Policy and the National Security Council. — Jonathan Gardner

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time on June 25 since the HHS secretary abruptly fired their predecessors earlier in the month

While the advisers didn’t vote on any new recommendations, they probed aggressively into the evidence underpinning use of vaccines for COVID-19 and signaled plans to look at other established shots, like those for hepatitis B and measles.

Read more here.

Six medical groups and a pregnant physician have sued HHS Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.

Filed July 7, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”

Read more here.

The Trump administration could issue a rule this year requiring healthcare companies to share more information on drug costs, as it pushes for greater price transparency in the sector, CMS Mehmet Oz said at a June 24 event.

The administrator’s comments suggest CMS could be considering rulemaking to force insurers and their pharmacy benefit managers, powerful middlemen in the pharmaceutical supply chain, to disclose the net prices of drugs, according to one expert.

Read more here. 

HHS Secretary Robert F. Kennedy Jr. on June 12 continued his efforts to alter the government structure supporting immunizations, naming vaccine skeptics and doctors with different focus areas to a critical advisory board days after purging the old one.

Kennedy shocked public health advocates and the vaccine industry on Monday by firing the 17 previous members of the Advisory Committee for Immunization Practices, or ACIP, which advises the CDC. The panel’s recommendations are crucial for setting inoculation schedules, maintaining federal vaccine assistance programs and shaping private insurance coverage.

Read more here. 

HHS secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding the CDC’s vaccine recommendations, creating fresh uncertainty about the way the public health agency might scrutinize new and existing shots going forward.   

In an op-ed published in The Wall Street Journal June 9, Kennedy said the move was designed to “re-establish public confidence in vaccine science” and eliminate the “conflicts of interest” and “skewed science” pervading the panel. Analysts, however, warned that their replacements could be more aligned with RFK Jr.’s disproven beliefs about the alleged dangers of vaccines. 

Read more here. 

Hundreds of HHS employees have been reinstated after mass layoffs at the department earlier this year, according to agency head Robert F. Kennedy Jr.

The HHS has reinstated 722 workers at the CDC and 220 employees at the NIH, Kennedy said during a House Energy and Commerce subcommittee meeting on Tuesday.

Additionally, the secretary said he returned more than 300 people to the National Institute for Occupational Safety and Health, including for a program that provides care for first responders and survivors of the 9/11 attacks.

Read more here.

The NIH is building a strategic plan on artificial intelligence in healthcare, an agency official said during a meeting held by the Coalition for Health AI.

The plan aims to guide AI research funding and initiatives in the sector “for years to come across the entire agency,” according to Matthew Memoli, principal deputy director at the NIH.

The NIH is issuing a request for information to inform the agency’s approach to the plan. Responses are due by July 15, Memoli said at the CHAI summit. The group was formed to create standards for the adoption of AI in healthcare.

Additionally, Memoli discussed some of the NIH’s priorities under the Trump administration, including creating reliable datasets that can be used for AI tools and “taking risks” on large research projects.

The HHS has signaled interest in AI tools during the Trump administration. The Food and Drug Administration in early June launched a generative AI product aimed at improving efficiency in its workforce, according to the agency. — Emily Olsen

Moderna will test its recently approved COVID-19 vaccine in a new placebo-controlled study, according to HHS Secretary Robert F. Kennedy Jr. 

In a post to the social media site X, Kennedy said the FDA “will monitor and collect data throughout the trial for every adverse outcome—not just a table list of expected outcomes.”

Moderna did not respond to BioPharma Dive’s request for comment. 

For approval of mNexspike, Moderna submitted Phase 3 study data evaluating the shot against its original COVID vaccine Spikevax. Moderna said mNexspike matched Spikevax’s in efficacy, and even appeared slightly more protective in people older than 12. 

According to an FDA letter for mNexspike’s approval, the agency is requiring Moderna conduct, among other surveillance, a placebo-controlled trial in adults aged 50 to 64 years. It must begin the trial by the end of November and deliver interim results by next May, according to a timeline outlined in the document.

MNexspike is cleared for people aged 12 to 64 years of age who are at high risk of severe disease, and healthy adults over the age of 65.

COVID vaccines, specifically those using mRNA technology, have faced higher scrutiny under the Trump administration.

Last month, the FDA outlined a new, stricter framework for COVID approvals in healthy adults, potentially limiting accessibility. Kennedy has also said the CDC will no longer recommend shots in healthy children and pregnant women, although there has been some conflicting messaging on that score.

Moderna’s shot targets the JN.1 covid variant and is expected to be available in the fall. 

CDC advisers will meet this month to vote on vaccine recommendations, but it’s not clear if FDA and HHS will continue to follow the usual procedures for issuing guidance. — Delilah Alvarado

HHS has released a more detailed budget proposal that shows the extent to which it intends to reshape the NIH.

The updated proposal reveals HHS’ plans to nearly halve the NIH’s budget, eliminate more than 5,000 contracts and scrap dozens of federal healthcare and social welfare programs.

HHS’ discretionary funding would be cut from $127 billion in 2025 to $95 billion in 2026, while the NIH would lose almost $18 billion of its discretionary budget. The NIH’s 27 institutes would be trimmed down to just eight as well. Though the National Cancer Institute, the National Institute of Allergy and Infectious Diseases and the National Institute on Aging would survive, they’d all have a smaller budget.

The proposal assumes that a 15% cap on indirect costs for research institutions, which has been blocked by the courts, will continue next year

Biotech investors and researchers have warned that the planned cuts could stifle U.S. medical innovation at a time when the country’s biopharmaceutical industry is losing ground to China. — Ben Fidler

HHS has provided more details on President Donald Trump's ambitious, but vague plan to link pharmaceutical prices in the U.S. to those paid abroad. 

In a brief statement on May 20, HHS said that it "expects" drugmakers to align U.S. prices of their brand-name medicines to the lowest price among OECD countries whose per-capita gross domestic product is at least 60% of the U.S.'.That cut-off would include countries like Denmark, Australia, Sweden, Germany, Canada and Israel.

“For too long, Americans have been forced to pay exorbitant prices for the same drugs that are sold overseas for far less,” HHS Secretary Kennedy said in the statement. “That ends today. We expect pharmaceutical manufacturers to fulfill their commitment to lower prices for American patients, or we will take action to ensure they do."

It's not entirely clear how HHS would take action. Trump's executive order, which HHS is acting on, indicated new prices would be set through regulation or legislation. But this "most favored nation" approach to drug pricing was reportedly left out of Congressional budget discussions and new regulations are likely to be challenged by industry in court. 

The agency's statement also doesn't specify what they mean by "price," which can indicate a range of figures adjusted for various discounts and rebates. Not all prices are publicly available, either. 

"Our take is that the Administration's demand is extreme, and we do not think that the industry can deliver what is stated," wrote Leerink Partners analyst David Risinger in a client note.

The statement hinted, though, that the administration expects some cooperation. "President Trump and Secretary Kennedy look forward to highlighting commitments in the coming weeks," it said. — Ned Pagliarulo

Nearly two months ago, President Donald Trump named acting CDC director Susan Monarez as his pick to run the agency permanently. (His first pick, Dave Weldon, withdrew over scrutiny of his vaccine views.)

His nomination of Monarez seems to have meant she could not continue as acting director, leaving a leadership void, as Inside Medicine's Jeremy Faust reported in April.

Pressed on this point by Sen. Lisa Blunt Rochester, D-Del., at a May 14 Senate hearing, Kennedy said CDC Chief of Staff Matthew Buzzelli is now serving as acting director. 

While Kennedy described Buzzelli as a "public health expert," his CDC biography describes him as a trial attorney who previously worked in private equity and consulting.

The issue of who's in charge is obviously an important one. But it also has immediate consequences, as the CDC director — acting or permanent — has responsibility for signing off on vaccine recommendations from the agency's panel of advisers. 

That panel met in April, making a number of recommendations on shots for respiratory syncytial virus, chikungunya and meningococcal disease. Those recommendations seem to be in limbo, at least for the time being. — Ned Pagliarulo

During a May 14 committee meeting, Sen. Josh Hawley, R-Mo., questioned HHS Secretary Kennedy on whether he would "review" the abortion pill mifepristone, citing a new study that claims to show higher rates of severe complications than currently indicated by the FDA's labeling. 

"[The study] indicates at the very least the label should be changed,” Kennedy said. “I’ve asked Marty Makary to do a complete review and to report back."

During his confirmation hearing, FDA Commissioner Makary had said he would take a hard look at mifepristone data gathered under the agency's Risk Evaluation and Mitigation Strategy, or REMS, program.

Mifepristone, and access to it, has been the focus of a legal battle that reached the Supreme Court last year. The high court ultimately preserved broadened access to the pill that the FDA had established in 2016 and 2021. 

"I feel that policy changes will ultimately go through the White House and President Trump," Kennedy said.

Mifepristone has been on the market for over two decades and was demonstrated safe and effective in multiple studies. — Delilah Alvarado

The large-scale layoffs conducted by HHS on April 1 were marked by confusion, clerical errors and poor communication. In the weeks since, some cut employees have been rehired as HHS leadership responds to backlash, lawmaker criticism and lawsuits. 

As a result, the actual extent of the layoffs remains unclear. At a Senate committee hearing on May 14, Sen. Tim Kaine, D-Va., shared numbers he said were relayed to the panel's staff during a mid-April briefing. While they are possibly now out-of-date, they are one of the most precise accountings of the layoffs. 

Among the cuts, Kaine said, were 2,519 FDA workers, 2,473 CDC employees and 1,312 NIH staff.These numbers, he added, were only individuals laid off April 1, and don't include any who took early retirement offers or were otherwise forced out in prior cutbacks. 

“I pushed back on certain ones and canceled certain ones,” said Kennedy, who noted he could have blocked earlier layoffs of probationary workers in February. He didn’t, however. — Ned Pagliarulo

Secretary Kennedy faced a forceful challenge from Sen. Chris Murphy, D-Conn., during a May 14 Senate committee hearing. 

Murphy sharply criticized Kennedy's comments on the measles vaccine, adding to criticism the secretary has faced over his handling of an outbreak that's led to more than 1,000 confirmed cases and the death of two children. 

“When you say you support the measles vaccine and then go out and repeatedly undermine the vaccine with information that is contested by public health experts, that is not supporting the vaccine,” Murphy said.

Kennedy has a long history of questioning vaccines, including the MMR shot that's proven highly effective. When pressed in recent weeks about his stance, he has offered muted support for vaccination, but also touted fringe treatments. 

At the May 14 hearing, he doubled down on false statements, such as erroneously claiming the vaccine contains the debris of aborted fetuses. “I am not going to just tell people everything is safe and effective if I know there’s issues,” Kennedy said. 

Murphy argued Kennedy has overseen changes to vaccine policy that go against promises he made during his confirmation hearing and to Sen. Bill Cassidy, R-La., the chairman of the Health, Education, Labor and Pensions committee. 

Cassidy fact-checked Kennedy on his claim that nearly all childhood vaccines haven't been tested in placebo-controlled studies prior to licensing. 

"For the record that is not true," Cassidy said. "The rotavirus, measles and HPV vaccines have been and some vaccines are tested against previous versions. So just for the record to set that straight."

Vaccines are sometimes tested against currently available shots, rather than placebo, because denying trial participants access to the standard of care is considered unethical. — Delilah Alvarado

The NIH and the Centers for Medicare & Medicaid Services on Wednesday announced a partnership to support research into the causes of autism using data from Medicare and Medicaid.

The two agencies will create a real-world data platform to evaluate claims information, electronic medical records and consumer wearables data from people enrolled in Medicare and Medicaid. The platform will operate under a CMS data use agreement and focus on enrollees diagnosed with autism spectrum disorder, according to a Wednesday statement. The platform will eventually be used to support research on other chronic illnesses.

Addressing chronic diseases in children, especially autism, is a top priority of the administration’s Make America Healthy Again commission. In March, the Centers for Disease Control and Prevention announced it would conduct a large study to probe whether there are links between vaccination and autism, despite years of studies finding evidence to the contrary. 

Last month, Kennedy . pledged his agency would “begin to have answers” on autism’s cause by September. Kennedy has for years spread misinformation linking the neurological disorder to vaccines.

The NIH and CMS said the new platform would comply with privacy laws, but did not give specifics. — Delilah Alvarado

The Trump administration aims to reduce HHS spending by more than one quarter in the next fiscal year, proposing deep cuts to the NIH and CDC in a “skinny” budget request released Friday.

NIH funding would be slashed by nearly $18 billion under the proposal, which outlines changes in appropriations that the White House wants Congress to adopt. The CDC would lose roughly $3.5 billion. Congress does not have to follow the administration’s requests.

Overall, the budget outline calls for a 23% reduction in base non-defense discretionary spending. HHS is somewhat harder hit, with a proposed 26% cut to funding for fiscal year 2026, or about $33 billion less than what the Office of Managed Budget said was enacted for the current year. An earlier OMB document that was leaked had called for $40 billion in HHS cuts.

No cuts to the FDA are specified in the outline, which is a change from reductions laid out in the earlier document.

In describing the cuts to NIH, the proposal lays out a litany of complaints Trump administration officials have lodged against the world’s largest public funder of biomedical research. The White House aims to consolidate the agency’s institutes around five new focus areas: body systems, neuroscience, general medical sciences, disability and behavioral health.

The budget does, however, call for $500 million in new funding to support the establishment of the Make America Healthy Again initiative, which is stays would help HHS Secretary Kennedy “tackle nutrition, physical activity, healthy lifestyles, over-reliance on medication and treatments, the effects of new technological habits, environmental impacts, and food and drug quality and safety across HHS.” — Ned Pagliarulo

HHS appears to be changing vaccine review policy under Secretary Kennedy. According to an agency spokesperson, all new vaccines will now need to be tested in placebo-controlled trials prior to FDA approval.  

Many experimental shots already are, but others are evaluated against an active comparator. And in the case of seasonal vaccines, like those for influenza and COVID, annual updates to better match circulating strains are typically made without conducting placebo-controlled studies.

"Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products," HHS spokesperson Andrew Nixon wrote in an email. 

Both Novavax and Moderna have recently been asked to provide additional clinical trial data for vaccines they had submitted for FDA approval. (Novavax did complete a placebo-controlled study, but HHS noted the data is now four years old.)

The new policy could be costly and time-consuming for some biotechnology companies, as well as unethical in certain circumstances. Pneumococcal conjugate vaccines are one example, Leerink Partners analyst David Risinger wrote in a client note: "It is difficult to fathom how it would be ethical to require placebo-controlled trials and how subjects would be motivated to enroll in a trial in which they are at risk of receiving placebo." 

The update “highlights increased scrutiny and (potentially) a higher bar for success in vaccine development – especially novel vaccines," Mani Foroohar, Risinger's Leerink colleague, added in the same note. 

Nixon also noted plans to build new vaccine safety surveillance systems, claiming that current systems like "VAERS" and the Vaccine Safety Datalink are inadequate. — Delilah Alvarado 

Read more on Moderna here.

HHS and the National Institutes of Health have launched a new research initiative to develop universal vaccines against "pandemic-prone" viruses. 

Dubbed Generation Gold Standard, the initiative is being led by the NIH’s National Institute of Allergy and Infectious Diseases, according to a May 1 statement. According to The Wall Street Journal, the project will receive $500 million in government funding.

“Generation Gold Standard is a paradigm shift,” said NIH Director Dr. Jay Bhattacharya. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats — not just today’s, but tomorrow’s as well using traditional vaccine technology brought into the 21st century.”

Research will center on beta propiolactone-inactivated, whole-virus platform, which is the basis of two universal influenza and COVID vaccines candidates. The hope is that these shots could protect against multiple strains at once, such as the coronaviruses SARS-CoV-2, SARS-CoV-1 and MERS-CoV. 

In the future, the platform could be deployed against RSV, metapneumovirus and parainfluenza, the agencies said in their statement. 

Clinical trials for the universal flu vaccine are slated to begin in 2026. An intranasal candidate is already in testing. 

In the past, these funding awards were typically administered via the Biomedical Advanced Research and Development Authority, or BARDA, which, in the final days of the Biden administration, awarded Moderna a grant to develop pandemic influenza and bird flu shots. 

However, HHS and NIH said they are "realigning" BARDA's operations. Reports previously indicated Moderna's funding may be withdrawn as well. — Delilah Alvarado

A draft budget document shows the Trump administration’s plan to slash funding to the HHS includes substantial cuts to the FDA.

The preliminary budget sets a total of $2.9 billion in requested congressional appropriations for the FDA, according to Steven Grossman, the former executive director of Alliance for a Stronger FDA, and a copy of the document obtained by MedTech Dive. That would be a roughly 18.6% decrease from $3.6 billion in budget authority the FDA received in its 2024 fiscal year.

The fiscal 2026 budget must be passed by Congress and could look different from the current proposal.

Read more here.

The FDA will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced April 17.

Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.

Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.

Read more here.

President Trump on April 16 said his administration would try to address one of the pharmaceutical industry’s biggest complaints with the Inflation Reduction Act of 2022. 

In a wide-ranging executive order, Trump directed HHS Secretary Robert F. Kennedy Jr. to work with Congress to modify a portion of the law that differentiates between small molecule drugs and biologic medicines for purposes of Medicare price negotiations. 

Currently, a small molecule drug becomes eligible for government-negotiated prices nine years after approval, compared with 13 for biologics. While Trump’s order only directs Kennedy to work with Congress to “align” the treatment of the different medicines, the industry is hopeful that would mean pushing back the timeline for pills to 13 years, closer to the expected end of patent protection. 

Read more here.

Biotech executives and venture capital investors are banding together to press Congress to act on FDA layoffs they say are already impacting drug development.

In a letter to Bill Cassidy, R-La., the head of the Senate’s health committee, dozens of executives and investors said the Senate needs to identify how the FDA has been affected “in order to quickly preserve and restore its core functions.” Drug development timelines, feedback for industry and regulatory judgment are all at risk, they said.

Read more here.

Research universities won an extended reprieve April 4 when a federal judge permanently barred the NIH from capping funding for indirect research costs at a 15% rate, a move that would cost institutions billions a year. 

U.S. District Judge Angel Kelley ruled NIH had violated federal statute, was “arbitrary and capricious” in creating the cap, failed to follow rulemaking procedures when doing so and violated constitutional prohibitions on applying new rules retroactively. 

The permanent injunction came in response to NIH’s request earlier on Friday for a final judgment in the case so as to expedite the appeals process — meaninglitigation is very likely to continue.

Read more here.

A Senate committee hearing involving HHS Secretary Robert F. Kennedy Jr. won’t happen this week as initially proposed by the panel’s leading lawmakers, who are seeking answers on the deep-cutting restructuring of the health department that Kennedy ordered last month. 

Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., sent an invitation to Kennedy on April 1, the same day layoff notices went out to thousands of federal health workers across the FDA, CDC and other agencies overseen by HHS.

In their letter, Cassidy and Sanders asked Kennedy to give an update on the reorganization to the Senate Committee on Health, Labor and Pensions on April 10. However, hearings must be scheduled at least seven days prior, and as no official notice has gone out, the proposed hearing won’t take place on April 10.

The Trump administration will not permit Medicare to pay for obesity drugs directly, declining April 4 to finalize a Biden-era proposal that would have allowed the federal health insurance program to cover popular GLP-1 medicines like Wegovy and Zepbound.

The decision is a setback for drugmakers, especially Novo Nordisk and Eli Lilly, that had sought a green light. However, few market watchers expected the Trump administration, which has made cutting government spending the priority of its first few months in Washington, to greenlight the policy, which carried an estimated 10-year cost to taxpayers of tens of billions of dollars. 

Still, CMS didn’t entirely rule out the possibility of expanded coverage, noting it could address Medicare prescription drug coverage of obesity medications in future rulemaking. Currently, Medicare is forbidden by law from covering drugs for weight loss specifically.

Read more here. 

The FDA’s review deadline for Novavax’s COVID-19 vaccine has come and gone amid the agency’s major organizational shake-up.

Novavax said April 3 the deadline passed for its vaccine without an update from the FDA, even though the company believes it responded to all of the agency’s requests. However, reporting by Politico and The Wall Street Journal indicated new senior leaders at the FDA intervened with the application. HHS spokesperson Andrew Nixon said this is “false.” 

The protein-based vaccine, which has been under emergency use authorization since 2022, was set to receive an approval decision by April 1. 

Read more here.

Employees who were supposed to receive layoff notices didn’t get them. Notices that did go out had the wrong office name, or specified an office that no longer exists. Some employees were told that, if they had discrimination complaints, to reach out to an equal opportunity office director who died last year.

The broad reduction in force for HHS, which agency head Robert F. Kennedy Jr. ordered last week, began April 1. It was a mess, according to many sources who worked across the large federal health department.

Thousands of civil servants, from low-level staffers to leaders, were cut across multiple HHS agencies, including the FDA, CDC, NIH and CMS.

Read more here. 

Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on March 28, citing disagreement with HHS Secretary Robert F. Kennedy Jr.

Marks, who helped lead the successful advancement of COVID-19 vaccines during the first Trump administration, said he had tried to address Kennedy’s concerns around vaccine safety and transparency.

“However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in a letter to acting FDA Commissioner Sara Brenner, a copy of which was obtained by BioPharma Dive.

Read more here. 

HHS secretary Robert F. Kennedy Jr. plans to dramatically reshape the department he leads through mass layoffs and consolidation of the sprawling agency that provides health insurance to tens of millions of Americans, responds to disease outbreaks and regulates medical products.

About 10,000 full-time employees at HHS will be let go under Kennedy’s plans, which were announced March 27. The planned terminations are in addition to the roughly 10,000 or so employees who have already left HHS through other Trump administration efforts, such as offers of early retirement. All told, the department will shrink in size by about 25% to about 62,000 full-time employees.

HHS will also centralize many functions that are currently spread out across the department, consolidating work involving human resources, information technology, procurement and policy. The number of HHS regional offices will be cut in half to five, and the department’s 28 divisions will be reduced to 15.

Read more here.

The U.S. Senate on March 25 confirmed Johns Hopkins University surgeon Martin Makary to be FDA commissioner, giving him authority over an agency that regulates a wide swathe of the U.S. economy that includes food, tobacco, drugs and medical devices.

Three Democrats joined 53 Republicans to confirm Makary in a 56-44 vote. Sen. Bernie Sanders, the senior minority member of the Senate Health, Education, Labor and Pensions Committee, voted no.

Makary will be under pressure to change the FDA’s direction on some drug regulation issues in response to guidance from Trump and new HHS Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic. Direct-to-consumer drug advertising could receive renewed scrutiny, although Trump failed to ban it in his first administration. Trump has also raised concerns about the role of pharmaceuticals in chronic disease trends, the topic of a recent closed-door federal commission meeting.

Read more here.

A meeting of the CDC’s Advisory Committee on Immunization Practices has been rescheduled for April 15 and 16. The meeting was supposed to take place in February but was abruptly canceled.

Advisers will discuss the current measles outbreak as well as vaccines for COVID-19, human papillomavirus, monkeypox and respiratory syncytial virus, among others. The meeting had previously been slated to discuss influenza strains, but that item is no longer part of the agenda.

Read more here.

CMS has signed agreements with the 12 companies whose drugs will be involved in the next round of price negotiations, the agency said Friday.

The CMS will next hold a series of roundtable meetings and make initial “maximum fair price” offers to drugmakers before working to negotiate a final price by Nov. 1. Fifteen drugs are subject to negotiations in this round, including diabetes and obesity drugs Ozempic and Wegovy, cancer medications Calquence and Ibrance and depression treatment Vraylar. The new prices will take effect in 2027.

The FDA on March 14 recommended influenza vaccine formulations to manufacturers for the upcoming season without seeking advisory input as it usually does.

The FDA determined formulations for the 2025-26 flu season during a meeting with staff from the CDC and Department of Defense. Typically, the FDA forms its recommendations after consulting outside advisors, a meeting with whom was scheduled for March. The meeting was canceled without reason — the second vaccine review disrupted under HHS Secretary Robert F. Kennedy Jr.

The FDA recommended flu shots to target H1N1, H3N1 and B/Victoria influenza lineages. The agency set its guidelines after reviewing data on currently circulating strains as well as the efficacy of the shots now on market.

Read more here. 

Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of agency staffing if confirmed but didn’t offer any views on the appropriateness of layoffs ordered by the Department of Government Efficiency.

At a Senate confirmation hearing on March 6, the Johns Hopkins University surgeon said he wasn’t involved in decisions to fire hundreds of FDA employees, but vowed to make sure that the staff has “all the resources they need to do their job well.”

Read more here. 

A meeting with advisers from the FDA’s Vaccines and Related Biological Products Advisory Committee to determine upcoming flu vaccine formulations has been canceled. The meeting, which was scheduled for mid-March, is the second to be disrupted under new HHS Secretary Robert F. Kennedy Jr.

The meeting is typically held annually to determine which strains of influenza to target ahead of the upcoming flu season in the fall and winter. Committee members review recommendations that come out of an annual meeting held by the World Health Organization before giving advice to the FDA.

Read more here.

The first meeting of the year with vaccine advisers to the Centers for Disease Control and Prevention was suddenly postponed. The meeting, planned for Feb. 26 to Feb. 28, was set to discuss vaccines for several infectious diseases including respiratory syncytial virus, meningococcal disease and human papillomavirus.

An HHS spokesperson confirmed the meeting was “postponed to accommodate public comment in advance of the meeting.” However, Politico reported health secretary Robert F. Kennedy Jr.  is considering whether to remove members of the vaccine panels that advise the federal government. 

Read more here.

The Trump administration on Feb. 11 directed federal agencies to “undertake plans for large-scale reductions in force” as part of a sweeping plan to shrink the size of the U.S. government.

The executive order instructed agency heads to coordinate their plans with the Department of Government Efficiency, the cost-cutting initiative led by Elon Musk, one of Trump’s closest advisers and the world’s richest person.

The order tasked agencies to prioritize for layoffs all temporary employees and any staff of offices not “mandated by statute or other law.” Additionally, the order laid the groundwork for a policy limiting hiring to no more than one employee for every four that leave their positions.

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