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

A federal judge in Rhode Island has blocked HHS Secretary Robert F. Kennedy Jr.’s layoffs of some employees in his department because it violated federal laws regulating major changes in government programs.

The ruling temporarily blocks HHS from following through on the terminations announced April 1, as well as laying off more employees or putting them on temporary administrative leave.

Nineteen states and the District of Columbia sued HHS, claiming that the agency’s plan to consolidate 28 divisions into 15 and 10 regional offices into five had caused the states irreparable harm because it shut down or limited access to HHS programs on which states rely.

The decision was “arbitrary and capricious” and didn’t follow normal decisionmaking processes governed by the Administrative Procedures Act, Judge Melissa DuBose ruled.

The states also argued the orders violated Congress’ constitutional authority to establish and fund HHS programs, but DuBose did not rule on the constitutional claims.

The ruling specifically applies to the Centers of Disease Control and Prevention, the FDA’s Center for Tobacco Products, the Office of Head Start and Head Start employees in regional offices, and the Office of the Assistant Secretary for Planning and Evaluation. — Jonathan Gardner

The National Institutes of Health 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

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

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

The NIH and the CMS 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. 

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

Read more here.

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

The Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Healthcare Research and Quality, and the Administration for Community Living would be cut under the plan. It would also eliminate Head Start, which provides early child care to low-income families.

Some programs would be consolidated under the Administration for a Healthy America, a new division proposed by Kennedy.

All told, the HHS’ budget would be reduced from roughly $120 billion in fiscal year 2024 to about $80 billion in fiscal year 2026.

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

Read more here.

The CMS won’t approve or extend federal Medicaid funding requests for certain state health programs.

The health programs, dubbed designated state health programs and designated state investment programs, aim to address social determinants of health.

Regulators said the programs duplicate resources available through other methods and serve as an “overly-creative financing mechanism to skirt state budget responsibilities.” In 2017, the Trump administration said it wouldn’t approve or renew state funding requests for DSHPs, a course the Biden administration ultimately reversed.

One expert said states will likely stop proposing these projects to the federal government — and if they want to fund these types of social needs programs, they’ll have to fund them on their own. — Emily Olsen

Read more here.

The House passed a budget resolution that could set the stage for significant cuts to Medicaid, in a win for Republicans who had to work until the 11th hour to convince some conservative lawmakers to approve the measure.

The resolution calls for $4 billion in budget cuts, far less than the at least $1.5 trillion initially proposed by House Republicans in February.

The House’s initial budget blueprint called for the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880 billion in spending reductions. That target is likely impossible to hit without cutting major healthcare programs under the committee’s purview, according to the Congressional Budget Office.

The Senate version of the blueprint retained the $880 billion reduction, but it also allows the Senate Committee on Finance, which also has jurisdiction over Medicare and Medicaid as well as tax and other fiscal policy, to add up to $1.5 trillion to the federal deficit. — Emily Olsen

Read more here.

The Trump administration finalized a 5.1% benchmark increase for Medicare Advantage plans, significantly higher than what the Biden administration proposed in January. All told, it should result in more than $25 billion in additional payments to MA plans next year, although the real sum will be higher, according to the CMS.

The CMS also completed phasing in changes to insurers’ coding practices meant to make it harder for companies to inflate members’ sickness for higher reimbursement.

The rate increase is one example of how the Trump administration is attempting to balance supporting MA plans with attempts to reform the program. — Rebecca Pifer

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. — Ned Pagliarulo

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 that day for a final judgment in the case so as to expedite the appeals process — meaning litigation is very likely to continue. — Ned Pagliarulo

Read more here.

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. — Rebecca Pifer

Read more here. 

The Senate confirmed Dr. Mehmet Oz, a physician and TV personality, to lead the CMS, the federal agency responsible for providing health insurance to more than 160 million people. 

He takes the reins of the CMS at a turbulent time for federal health programs and agencies after the HHS, which oversees the CMS, announced it would cut 10,000 full-time employees in a major restructuring. Republican lawmakers are also weighing cuts to Medicaid.

During his confirmation hearings, Oz largely avoided questions on whether he would support cuts to the safety-net insurance program. However, he said he would support Medicaid work requirements, which tie eligibility for the insurance to work, volunteer or education hours.

He also promised to scrutinize Medicare Advantage insurers, after Democrats criticized Oz for his advocacy for and financial ties to the plans. — Emily Olsen

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 the HHS, which agency head Robert F. Kennedy Jr. ordered in late March, 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. — Rebecca Pifer

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 around 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. — Rebecca Pifer

Read more here.

The HHS terminated $11 billion in public health funding approved by Congress during the COVID-19 pandemic, arguing the funds had outlived their function now that the “pandemic is over.” The funds were allocated for a broad range of programs, including vaccination clinics and others that supported healthcare workers and substance abuse prevention.

A federal judge issued an emergency restraining order to temporarily block the cuts after 23 states and Washington D.C. sued to stop the funding freeze. States filed thousands of pages of exhibits attached to their lawsuit detailing alleged harms associated with the terminated funds. — Susanna Vogel

Read more here.

The CMS Innovation Center is canceling four payment models early and halting two demonstrations before they begin. Four models, Maryland Total Cost of Care, Primary Care First, End-Stage Renal Disease Treatment Choices and Making Care Primary, will end by Dec. 31.

The Trump administration said cutting the demonstrations — which test new payment and delivery models with the goal of lowering costs and improving quality in government healthcare programs — will streamline functions and reduce spending.

The canceled models affected millions of patients across the country. The CMS estimated terminating the programs early will save nearly $750 million, though regulators did not quantify where those savings will come from. — Emily Olsen

Read more here.

The Trump administration proposed a new rule that would require ACA enrollees to provide more information to prove they’re eligible for subsidies and special enrollment periods, and charge people automatically re-enrolled in subsidized coverage a monthly premium until they confirm their eligibility.

The rule would also shorten the annual open enrollment period for ACA plans by one month and reduce opportunities for people with very low incomes to sign up for coverage. 

The new policies, meant to tackle fraud and abuse, will make it harder for Americans to enroll in the coverage, after ACA enrollment swelled to record highs during the Biden administration. — Rebecca Pifer

Read more here.

Trump released an executive order directing three federal agencies to develop a framework to enforce an executive order the president released during his first administration targeting price transparency.

During Trump’s first administration, he ordered hospitals to publicly disclose prices reflecting what patients and insurers “actually pay” for services. Hospitals will be required to disclose actual prices of services, not estimates, and post information in a standardized fashion that is easily comparable across hospitals and health plans.

The president blamed the Biden administration for not enforcing the rules and promised a stronger stance on noncompliance. Advocacy groups say hospitals have mostly dropped the ball on implementing hospital price transparency measures, which went into effect under CMS guidance in 2021. — Susanna Vogel

Read more here.

Robert F. Kennedy Jr., a prominent vaccine critic who President Donald Trump directed to “go wild” on healthcare, was confirmed by the U.S. Senate as HHS secretary. 

The 52 to 48 vote to confirm Kennedy was nearly along party lines except for Sen. Mitch McConnell, R-Ky., who joined with the 47 senators caucusing with the Democrats in opposition.

Sen. Bill Cassidy, R-La., was a key vote to secure Kennedy’s confirmation to lead the HHS. Cassidy, a physician, had admitted to “struggling” with Kennedy’s history of promoting vaccine misinformation during a confirmation hearing. Ultimately, he voted to confirm him Thursday, after Kennedy promised to “work within” existing vaccine approval and safety systems.

As HHS secretary, Kennedy will run one of the federal government’s largest agencies, which oversees the Food and Drug Administration, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services. 

He’s promised to tackle the country’s rising incidence of chronic disease and take aim at over-processed foods that contribute to obesity in a movement the administration has dubbed “Make America Healthy Again.”

Kennedy also said he would follow President Donald Trump’s lead on abortion policy, despite his prior political position supporting a woman’s right to choose.

Kennedy’s plans for other major healthcare programs he’ll now oversee, like Medicare and Medicaid, are unclear, however. During confirmation hearings, he made errors about how Medicaid was funded and fumbled Medicare basics.

Read more here. — Emily Olsen

House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880 billion in savings.

The entire resolution calls for $1.5 trillion in cuts over the next decade to help pay for an extension of Trump’s tax cuts.

The brunt of healthcare cuts could come from Medicaid, which provides coverage to almost 80 million Americans, since the Trump administration has said it won’t cut Medicare. 

Republicans could seek to pass Medicaid work requirements, which would require enrollees to log work, volunteer or education hours to qualify for coverage. They could also look to reduce the rate at which the federal government matches states’ Medicaid spending, or consider limiting supplemental payment programs in Medicaid.

Passing Medicaid cuts, however, may be tricky given Medicaid’s high approval rate among voters. — Emily Olsen

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 required 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. — Ned Pagliarulo

Read more here. 

Trump issued an executive order barring providers from offering gender-affirming surgeries and hormone treatments to patients under the age of 19, stating the federal government will not “fund, sponsor, promote, assist, or support” gender-affirming care for children. 

The executive order faced swift pushback from providers, including some medical groups who sued to stop the order from taking effect.

Major medical groups, including the American Medical Association, American Psychological Association and the American Academy of Pediatrics, support gender-affirming therapies for minors. — Susanna Vogel

Read more here.

Trump issued an executive order mandating federal agencies recognize only two sexes, prompting health agencies like the Centers for Disease Control and Prevention to purge public-facing materials that refer to gender identity instead of sex.

The purge caused many widespread, large-scale national health surveys, indices and dashboards that inform research and policymaking to go offline. — Sydney Halleman

Read more here.