Weekly Spotlight

For this week’s standard regulatory news (a little light this week) please scroll down. Below, we break down the reporting on the HHS purge: what we know / what we don’t know / and what all of this might mean going forward.

General HHS

Opinion: A former HHS secretary’s fears for America’s future

On this episode of the podcast, Shalala and I discussed her career in public health and her frustration with what’s happening at HHS now. We spoke on Monday morning, after the reorganization of the department was announced but before “reduction in force” layoffs began Tuesday. Our conversation was based in part on a recent First Opinion essay she wrote arguing that the reorganization was “silly” and “confusing.”

Musk, DOGE Created New HHS Org Chart

Elon Musk and his Department of Government Efficiency (DOGE) team created the new org chart for HHS, said Robert F. Kennedy Jr. during an interview. The HHS secretary said when he arrived at the department, the org chart was “incomprehensible,” and Musk “came in for the first time with a real org chart for the agency.”

Who Is RFK Jr.’s Special Adviser Calley Means? — Means and his sister, Casey Means, MD, are vocal “Make America Healthy Again” proponents

Calley Means and Casey Means, MD, have leveraged their entrepreneurial and medical backgrounds to launch themselves into HHS Secretary Robert F. Kennedy Jr.’s orbit and hold increasing influence in Washington. The sibling pair are vocal proponents of Kennedy’s Make America Healthy Again (MAHA) agenda. Calley Means was booed, shouted down and laughed at during a health conference while defending mass layoffs at the agency.

‘A cruel April Fool’s joke’: HHS layoffs characterized by confusion, errors

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

Inside Trump and RFK Jr.’s Health Agency ‘Bloodbath’

Current and former staffers say that after thousands of people were laid off, the future of agencies like the CDC and FDA are uncertain: ‘Shitshow is an understatement’

Laid off HHS leaders offered transfers to remote Indian Health Service regions

Amid the layoff notices sent to stunned employees of the Department of Health and Human Services Tuesday was yet another surprise: some of them were offered the chance to transfer to the Indian Health Service. Those who received the offer include Brian King, the top tobacco regulator at the Food and Drug Administration; Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases; Emily Erbelding, who directed the division of microbiology and infectious diseases at NIAID;  Diana Bianchi, director of National Institute of Child Health and Human Development; and Dylan George, director of the CDC Center for Forecasting and Outbreak Analytics.

Federal Health Workers Make Up Less Than 1% of Agency Spending

Health Secretary Robert F. Kennedy Jr. suggests that laying off thousands of federal workers would tame a massive budget. But nearly all of the agency’s money goes to hospitals, doctors and nursing homes.

Federal judge says she will temporarily block billions in health funding cuts to states

A federal judge will temporarily block President Donald Trump’s administration from cutting billions in federal dollars that support Covid-19 initiatives and public health projects throughout the country.

#All

Opinion: Decimation of HHS comms, FOIA offices will leave Americans in the dark about urgent health matters

Because in addition to cutting HIV prevention and combating smoking, Kennedy’s HHS gutted Freedom of Information Act (FOIA) and communications teams across the agency. The dismissal of these employees will make it harder for HHS agencies to communicate with the public, and that endangers Americans’ access to vital health information.

Rollout of ‘miracle’ HIV prevention drug is threatened by Trump cuts to global AIDS relief program

The medicine, lenacapavir, made by Gilead Sciences, has caused a stir because clinical trial data showed a single set of injections every six months could provide virtually complete protection against infection, a form of prevention known as pre-exposure prophylaxis, or (PrEP). The President’s Emergency Plan for AIDS Relief, or PEPFAR, has been poised to play the leading role in making lenacapavir available, given its experience distributing HIV prevention drugs around most of the world.

Opinion: The body of public health is taking two destructive hits at once

Over the past week, cuts to federal programs that have long-standing roles in public protection have been layered on top of massive funding reductions to state and local health departments. Public health and population protection are thus now at the most vulnerable levels in decades, with clear potential consequences.

US Senator Cassidy calls on Kennedy to appear before Senate panel over health agency cuts

The U.S. Senate Health, Education, Labor, and Pensions Committee will on April 10 hold a hearing on the reorganization of the Department of Health and Human Services, its chairman Senator Bill Cassidy said in a statement.Health and Human Services staff will brief the House Energy and Commerce Committee next week in the wake of a massive overhaul of the agency which included significant layoffs, said a spokesperson for chair Brett Guthrie.

AHRQ, ARPA-H, ASPE, ASPR, ATSDR, BARDA, HRSA, NIOSH, OASH, SAMHSA

Trump administration begins mass cuts of federal health policy researchers

More than half of employees at the Office of the Assistant Secretary for Planning and Evaluation and the Agency for Healthcare Research and Quality — both part of the Department of Health and Human Services — have been laid off, according to several current and former employees. The two agencies operate on less than $600 million combined, or about 0.04% of what the federal government spends on health care.

HHS emergency response unit given two days to figure out its fate

The George W. Bush-founded Administration for Strategic Preparedness and Response is caught in the crosshairs of Kennedy’s mass restructuring. Established to respond to national disasters from Hurricane Katrina to infectious disease outbreaks, ASPR has worked for two decades as an independent division within HHS, collaborating across the health, defense, and homeland security departments. Restructuring will include merging BARDA with Biden-founded ARPA-H

Trump administration to shut down CMS, HHS minority health offices amid restructuring

The CMS and HHS offices that coordinate efforts to eliminate health disparities are being shut down completely as part of the Trump administration’s overhaul of the federal healthcare department, according to sources with direct knowledge of the matter.

HHS cuts leave future of mental health, substance use hotlines uncertain

Hotlines that have fielded millions of calls from people — including new mothers — looking for mental health support or to quit smoking are in limbo after federal officials fired the workers who oversaw them.

Federal advisory panel on ethical, legal issues in human health research disbanded

The Secretary’s Advisory Committee on Human Research Protections is an 11-member panel of volunteers with expertise in bioethics and regulatory affairs that typically meets three times a year to provide recommendations to HHS’ Office for Human Research Protections.

Five Agencies Being Merged Into AHA: Here’s What They Do

The restructuring plans  announced by HHS last week included folding five offices into one entity: the Substance Abuse and Mental Health Services Administration (SAMHSA), the Health Resources and Services Administration (HRSA), the National Institute for Occupational Safety and Health (NIOSH), the Agency for Toxic Substances and Disease Registry (ATSDR), and the Office of the Assistant Secretary for Health (OASH).

CDC

CDC Cuts Threaten to Set Back the Nation’s Health, Critics Say

The reorganization that began on Tuesday will scale back an agency that has been a public health model around the world.

These CDC Teams Were Hardest Hit by Trump’s Mass Layoffs

The dust of the Trump administration’s reorganization of HHS is still settling, but it’s clear that several offices and divisions of the CDC were particularly hard hit by the reduction-in-force (RIF) that launched on April Fool’s Day.

Opinion: Former CDC Director Tom Frieden: Cuts to the agency will cost American lives and dollars

The CDC cuts announced Tuesday threaten America’s health, safety, and economy. Despite claims of efficiency, these cuts target proven programs that prevent disease and save lives — and as a result, Americans will be sicker and face increased health care costs. The government’s goal should not be to hit an arbitrary number of jobs eliminated, but to focus on the number of illnesses and premature deaths prevented.

CMS

HHS reorganization raises questions for claims appeals process

The Health and Human Services Department is changing how it manages three oversight and appeals offices.

#All

Oz confirmed to oversee health insurance for millions of Americans

Dr. Mehmet Oz was confirmed by the Senate to run the Centers for Medicare and Medicaid Services.

#All

FDA

Makary gets some critical reviews after first town hall at FDA

In his first address to FDA staff, Commissioner Marty Makary made sweeping declarations about the need to challenge scientific norms and identify the root causes of chronic disease, but he said little about specific plans for the agency and about the mass layoffs that roiled staff earlier this week, according to a recording of the meeting obtained by STAT.

#All

STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs

Marty Makary’s first official day as commissioner of the Food and Drug Administration began with employees in tears, learning from security guards that they were losing their jobs. The news release announcing the start of his tenure points readers to a press office that, after large-scale layoffs, basically no longer exists. His first email to staff summarized his resume.

#All

Top F.D.A. Vaccine Official Resigns, Citing Kennedy’s ‘Misinformation and Lies’

Dr. Peter Marks, a veteran of the agency, wrote that undermining confidence in vaccines is irresponsible and a danger to public health.

Stat+ Keeping A running list of senior FDA officials who have left the agency

Name	Title	FDA Center	Date	Replacement
Namandje Bumpus	Principal Deputy Commissioner	Office of the Commissioner	12/17/2024	Sara Brenner
Patrizia Cavazzoni	Director	Center for Drug Evaluation & Research	12/20/2024	Jacqueline Corrigan Curray (Acting)
Troy Tazbaz	Director, Digital Health Center of Excellence	Center for Devices & Radiological Health	1/1/2025
Bob Temple	Deputy Director for Clinical Science	Center for Drug Evaluation & Research	1/18/2025
Marjorie Shapiro	Chief, Laboratory of Molecular and Developmental Immunology	Center for Biologics Evaluation and Research	1/20/2025
Ross “Rusty” Segan	Director, Office of Product Evaluation and Quality	Center for Devices & Radiological Health	2/15/2025	Owen Faris (Acting)
Jim Jones	Deputy Commissioner	Human Foods Program	2/17/2025	Kyle Diamantas (Acting)
Celia Witten	Deputy Director	Center for Biologics Evaluation and Research	3/12/2025	Scott Steele (Acting)
Heather Lombardi	Director, Office of Cellular Therapy and Human Tissue CMC	Center for Biologics Evaluation and Research	3/12/2025	Megan Velez
Lola Fashoyin-Aje	Director, Office of Clinical Evaluation	Center for Biologics Evaluation and Research	3/12/2025
Marc Theoret	Deputy Director	Oncology Center of Excellence	3/27/2025
Paul Kluetz	Deputy Director	Oncology Center of Excellence	3/27/2025
Peter Marks	Director	Center for Biologics Evaluation and Research	3/28/2025
Carlotte Christin	Director, Office of Policy and International Engagement	Human Foods Program	4/1/2025
Brian King	Director	Center for Tobacco Products	4/1/2025
Hilary Marston	Chief Medical Officer	Office of the Commissioner	4/1/2025
James Myers	Associate Director for Policy	Center for Biologics Evaluation and Research	4/1/2025
Julie Tierney	Deputy Director	Center for Biologics Evaluation and Research	4/1/2025
Matthew Farrelly	Director, Office of Science	Center for Tobacco Products	4/1/2025
Patrick Raulerson	Director, Office of Regulatory Policy	Center for Drug Evaluation & Research	4/1/2025
Peter Stein	Director, Office of New Drugs	Center for Drug Evaluation & Research	4/1/2025
Sheryl Lard-Whiteford	Associate Director for Product Management	Center for Biologics Evaluation and Research	4/1/2025
Sridhar Mantha	Director, Office of Strategic Programs	Center for Drug Evaluation & Research	4/1/2025
Tristan Colonius	Chief Veterinary Officer	Center for Veterinary Medicine	4/1/2025

From https://www.statnews.com/2025/04/03/fda-senior-officials-exits-departures-list/ (4/4/2025)

FDA is looking for some laid-off employess to keep working

On Tuesday, thousands of Food and Drug Administratino workers were laid off. They were shut out from the government offices where they had worked and placed on administrated leave until June 2. But just hours after employess were shown the door, Barclay Butler, the agency’s new chief operating officer, asked top FDA officials to identify employess to keep working for the next two months, accordning to an email obtained by the Washington Post.

FDA’s Chief Medical Officer Hilary Marston is out amid mass layoffs

In her role, Marston oversaw the agency’s Office of the Chief Medical Officer (OCMO)—a unit designed to support medical product development and availability, promote patient health and advance innovative research—and served as the primary clinical advisor to the FDA commissioner. She led initiatives that support making effective and safe medical products available to Americans by ensuring timely reviews and promoting rare disease innovation.

‘FDA as we’ve known it is finished’: Former commissioner

Former Food and Drug Administration (FDA) Commissioner Robert Califf said the federal agency that he’s known for years “is finished” after mass layoffs began Tuesday morning.

‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs

Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people who work in communications and records requests; regulatory programs and administrative services; and other functions, according to two FDA employees and one person who was laid off from the agency yesterday. All three spoke to MedTech Dive on the condition of anonymity.

NIH

Scientists sue NIH, saying politics cut their research funding

A group of scientists and health groups sued the National Institutes of Health on Wednesday, arguing that an “ideological purge” of research funding is illegal and threatens medical cures.

Why a small journal’s ‘blueprint for NIH’ is getting so much attention

Normally, a perspective piece in a small, two-month old journal would not garner much attention. But, a paper published last week, called “A Blueprint for NIH Reform,” is circulating in academic circles as well as within the National Institutes of Health, as scientists search for hints of where the agency may go in the coming months and years.

Trump officials will screen NIH funding opportunities

HHS and the Department of Government Efficiency (DOGE) will review all NIH notices of new solicitations for grant proposals, Science reported

One of the darkest days’: NIH purges agency leadership amid mass layoffs

The NIH removed at least four directors — of the National Institute of Allergy and Infectious Diseases, the National Institute of Child Health and Human Development, the National Institute on Minority Health and Health Disparities, and the National Institute of Nursing Research — from their posts amid the mass layoffs. Some were offered reassignments to the Indian Health Service.

Billions to be slashed from NIH contracts

National Institutes of Health leaders must figure out how to cut $2.6 billion in contracts from the biomedical research agency’s budget by April 8, according to several sources.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Quality of care for heart patients does not improve in first year of ACO participation

Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.

#Patient, #Provider

APG Report Calls for Major Reforms to Medicare, Medicare Advantage

America’s Physician Groups (APG) has issued a report with detailed recommendations for reform suggestions for the Center for Medicare & Medicaid Services, including moving fully in the direction of accountable care in traditional Medicare and incentivizing two-sided risk payment arrangements between Medicare Advantage plans and physician groups.

#Provider

Food and Drug Administration (FDA)

FDA’s Critical Role in Keeping Medical Devices Secure

The US Food and Drug Administration (FDA) plays a critical role in regulating software in medical devices (SiMD) and software as a medical device (SaMD), under the FDA’s Quality System Regulation (QSR). So how do manufacturers and patient care environments navigate these regulations, particularly when it comes to urgent security patches?

#All

Hill Happenings

Sens. Moran, Baldwin, Capito, Kaine, Mullin, Hickenlooper Announce Senate 340B Bipartisan Working Group

U.S. Senators Jerry Moran (R-Kan.), Tammy Baldwin (D-Wis.) and Shelley Moore Capito (R-W.V.) welcomed Sens. Tim Kaine (D-Va.), Markwayne Mullin (R-Okla.) and John Hickenlooper (D-Colo.) as new members of the Senate 340B bipartisan working group.

#Drug, #Hospital

Notable Notes

What’s Ahead for Site-Neutral Payments in Medicare and State Policies | AMCP Annual 2025

Sean Shirk, Pharm.D., director of specialty clinical solutions at Prime Therapeutics, addressed three key points in a session he co-presented, titled “Legislative Impacts on Site of Service: What is the Big Deal?” While these legislative changes aim to reduce healthcare costs, they also raise concerns about how they could affect patients’ access to care and their treatment outcomes.

#All

SCAI Releases Landmark T-TEER eBook: The First Comprehensive Guide to Tricuspid Valve Repair

The Society for Cardiovascular Angiography & Interventions (SCAI) has published a first-of-its-kind educational resource for interventional cardiologists and imaging specialists performing Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER). Developed by leading experts in the field, the eBook provides step-by-step procedural guidance, patient selection criteria, imaging protocols, and best practices for achieving optimal patient outcomes.

#All

Leapfrog makes updates to annual hospital survey

Leapfrog Group has made several updates to its annual hospital survey, including changes to emergency department boarding, cybersecurity and natural disaster safety. The nonprofit watchdog group’s survey, which opens April 1, will now refer cybersecurity and natural disaster issues to its help desk as opposed to requiring provider respondents to report them on their survey.

#All

TAVR Equal to Surgery in Low-Risk Patients with Severe Aortic Stenosis | ACC 2025

Researchers found that at five years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

#Device

New TAVR research explores adverse outcomes, disease progression in patients with asymptomatic severe AS

Two separate studies at ACC.25 explored data from the EARLY TAVR trial. One analysis included stroke findings that surprised researchers.

#Device

TriClip’s Tricuspid TEER Cuts Heart Failure Hospitalizations

Champions of tricuspid transcatheter edge-to-edge repair (TEER) were buoyed by 2-year results of the TRILUMINATE trial marking the first report of reduced heart failure (HF) hospitalization for this technology. In the trial, people with severe tricuspid regurgitation (TR) showed a significant reduction in recurrent HF hospitalizations 2 years after tricuspid TEER with the TriClip G4 (0.19 vs 0.26 events per patient-year with medical therapy alone; HR 0.72, 95% CI 0.53-0.98), according to Saibal Kar, MD, of Los Robles Regional Medical Center in Thousand Oaks, California.

#Device

Cardiologists make case against routine interventions for asymptomatic severe AS

Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer.

#Device, #Provider, #Patient

Another Chapter in the PCI Vs. CABG Saga | ACC 2025

Compared with other studies, the differences in outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) narrowed in the FAME 3 five-year follow-up study, but there were fewer myocardial infarctions and repeat revascularizations in the PCI group.

#Provider

Pharmaceuticals are spared from tariffs, for now

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries that his administration sees as engaging in unfair trade. The White House wrote in a fact sheet, though, that pharmaceuticals are exempt from these tariffs.

#Drug

Amgen loses its battle against Colorado over a prescription drug affordability board

In a blow to the pharmaceutical industry, a U.S. court judge ruled that a Colorado state board can proceed with plans to place limits on the prices paid for medicines, the first such decision to support the controversial attempts by some states to control their prescription drug spending.

#Drug