Blog | 4/11/2025

Trump Administration Healthcare News: April 11, 2025

Health Advances weekly healthcare tracker focused on top level government administration news.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on April 10, 2025. The details and broad themes may have changed.

 

KEY FEDERAL GOVERNMENT NEWS

HHS' Proposed FDA Reorganization Would Drastically Alter Structure of Agency, Eliminate Product-Specific Offices

  • A plan to dramatically restructure the U.S. Food and Drug Administration (FDA) has been leaked, just days after 3,500 staffers were fired from the agency as part of an overhaul of the U.S. Department of Health and Human Services (HHS).
  • According to Inside Health Policy, the proposed reorganization would parse FDA into five newly created offices, with all of its product review divisions merged into a single Office of Product Evaluation and Regulation. This office would serve as a “central hub for product review and regulatory decision-making across drugs, biologics, devices, tobacco, and foods,” absorbing the existing, separate offices dedicated to reviewing these products.
  • Additionally, an Office of Inspections, Compliance, and Enforcement would combine the compliance units from each FDA Center, including the Office of Inspections and Investigations, which replaced the Office of Regulatory Affairs as part of the FDA reorganization that took effect in October 2024. An Office of Scientific and Regulatory Policy would also be formed from the ashes of FDA’s various policy offices, which took major hits during the sweeping HHS cuts implemented in the beginning of April.
  • Other offices that would be established by the proposed reorganization include 1) an Office of Administrative and Shared Services that would handle human resources, budget, information technology (IT), and training, 2) an Office of Strategic Programs and Innovation that would focus on cross-cutting agency initiatives and technology modernization, and 3) a Digital Health Center of Excellence, which would focus on long-term strategic planning and technology adoption.
  • The leaked HHS email provided to Inside Health Policy did not include information about how finalized the proposal may be or whether there is an established timeline for its implementation.

HHS Cuts Impacting Human Subject Research – No More SACHRP?

  • In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) has been disbanded. Formed in 2003, SACHRP was a federal advisory committee whose expert volunteers advised government agencies that regulate human subject research.
  • SACHRP provided advice and recommendations to HHS on a wide variety of cutting-edge human subject protection matters. Examples of recent SACHRP work product include guidance on decentralized clinical trials, research involving children and the use of artificial intelligence in human subject research.
  • Given that SACHRP was comprised entirely of volunteers, termination of this committee will have only a negligible impact on government expenditures – but the loss of this expert panel will immediately decrease sophisticated expertise on ethical and legal issues important to human subject research protections.
  • https://www.hklaw.com/en/insights/publications/2025/04/hhs-cuts-impacting-human-subject-research-no-more-sachrp#page=1

RFK Jr. says he's "not familiar" with all health program cuts in exclusive interview

  • In his first network TV interview since becoming Health and Human Services secretary under the Trump administration, Robert F. Kennedy Jr. spoke with CBS News chief medical correspondent Dr. Jon LaPook about the measles vaccine, major government cuts and health care costs.
  • Since his appointment in February, Kennedy has facilitated sweeping cuts affecting a wide range of programs and employees.
  • When asked by LaPook if he personally approved the more than $11 billion proposed in cuts to local and state programs that address infectious disease, mental health, addiction and childhood vaccination, Kennedy said, "No I'm not familiar with those cuts. We'd have to go … the cuts were mainly DEI cuts, which the president ordered."
  • LaPook provided Kennedy with an example of a $750,000 University of Michigan grant focused on adolescent diabetes, which was eliminated.
  • "I didn't know that, and that's something that we'll look at," Kennedy said. He added that he could not speak to if it should be considered a DOGE cut.
  • "I just, I'm not familiar with that particular study. But there's a number of studies that were cut that came to our attention and that did not deserve to be cut, and we reinstated them. Our purpose is not to reduce any level of scientific research that's important."
  • Around 10,000 HHS employees are being laid off in a restructuring move by Kennedy and Elon Musk's DOGE. The secretary acknowledged that some of the DOGE cuts will need to be reinstated.
  • “You may make mistakes, as much as 20[%], and then you go back and remedy that."
  • https://www.cbsnews.com/news/rfk-jr-sweeping-cuts-health-programs-employees-exclusive-interview/

A closer look at the nationwide impact of NIH cuts

  • Nearly half of all U.S. counties will experience economic losses of at least $250,000 as a result of the Trump administration's planned cuts to indirect funding by the National Institutes of Health, per the Science & Community Impacts Mapping Project.
  • Why it matters: Much of the discourse around the cuts has focused on the impact to states or individual universities. But this data compiled from a consortium of universities shows just how widespread the effects of the cuts would be at the local level, researchers tell Axios. More than 500 counties will lose more than $6.25 million in funding, their data shows.
  • https://www.axios.com/2025/04/09/nih-cuts-nationwide-impact-county-map

CMS finalizes 5.06% Medicare Advantage benchmark increase

  • The Centers for Medicare & Medicaid Services (CMS) finalized an increase of the average benchmark payments to Medicare Advantage (MA) plans by 5.06%, or $25 billion, on Monday.
  • It is nearly a three-percentage-point increase over the advance notice proposed in the waning days of the Biden administration and will be seen as favorable to payers. The CMS said this is due to the effective growth rate increase from 5.93% to 9.04% in the rate announcement.
  • “This change is primarily due to the inclusion of additional data on fee-for-service (FFS) expenditures, including payment data through the fourth quarter of 2024, which was not included on account of the early Advance Notice publication,” the agency said in a news release.
  • Rebasing and repricing ultimately brought the payments to plans down by approximately a quarter of a percent.
  • The CMS will also finish phase-in of the MA risk adjustment model and continue the phased-in approach for removing medical education costs from expenditures in growth rate calculations. Most insurers asked for the risk adjustment model to be paused.
  • https://www.fiercehealthcare.com/payers/cms-finalizes-506-medicare-advantage-benchmark-increase

Medicare Advantage final rule excludes anti-obesity drug coverage under Medicare, Medicaid

  • The Centers for Medicare & Medicaid Services (CMS) finalized a Medicare Advantage (MA) rule proposed by the Biden administration but is choosing to leave out the rule’s flashiest policy.
  • As outlined by the CMS, the Trump administration’s final rule will not include three proposals included in the initial proposal, including the plan to cover anti-obesity medications.
  • The previous administration attempted to have Medicare Part D and Medicaid cover anti-obesity drugs under the Contract Year 2026 MA and Part D rule, which would have substantially increased access to GLP-1 drugs for weight loss. (Some other indications are currently permitted.)
  • The rule also does not include an annual health equity analysis of utilization management policies and procedures nor new guardrails on artificial intelligence in the MA program.
  • Press: https://www.fiercehealthcare.com/payers/medicare-advantage-final-rule-excludes-anti-obesity-drug-coverage-under-medicare-medicaid
  • Rule:  https://public-inspection.federalregister.gov/2025-06008.pdf

Unique pain research office eliminated in HHS purge

  • Last week’s layoffs across the Department of Health and Human Services left a significant casualty in the vast ecosystem of government-backed science: an entire division focused on researching pain.
  • The reduction in force enacted last week by Health Secretary Robert F. Kennedy Jr. eliminated all but one full-time position, out of roughly a dozen, within the National Institutes of Health Office of Pain Policy and Planning, a unit devoted to coordinating pain-related research across the federal government.
  • None of the NIH’s 27 institutes focuses specifically on pain, leaving research into both acute and chronic pain, as well as its physiological causes and associated health outcomes, highly fragmented. By many measures, pain is the country’s most common disabling condition — 17 million people experience “high-impact” chronic pain, according to the Centers for Disease Control and Prevention.

HHS closes CDC lab that tracks STIs, alarming experts

Government shuts CDC office focused on alcohol-related harms and prevention

  • A small office that produced data on alcohol-related deaths and harms, and worked on policies to reduce them, has been shuttered by the Trump administration. Those involved with the work say it was the only group in the federal government focused on preventing excessive drinking and the many problems associated with it, including chronic diseases.
  • At least 11 states directly relied on the Alcohol Program in the Centers for Disease Control and Prevention for funding, data assistance and other guidance. The three-person, 24-year-old program was cut by the large reduction-in-force that began April 1 at Health and Human Services.
  • Most recently, the alcohol program was allocated $6 million for its work. Much of that went out the door, in grants to nearly a dozen state health departments so they could hire alcohol epidemiologists, conduct studies on excessive alcohol use, and try to reduce associated harms. Now, without the staff to tend to those five-year agreements, states are not sure if they will receive their final round of funding come fall.
  • https://www.statnews.com/2025/04/10/trump-cuts-cdc-program-alchohol-related-harm-6-million-budget-cut-felt-in-11-states/   (subscription required for full-text)

  Judge permanently blocks NIH grant caps, prompting HHS appeal

  • On Friday, a federal judge permanently blocked the National Institutes of Health from implementing indirect cost caps on research grants. The NIH is now appealing.
  • Kelley’s April 4 ruling prohibits the federal government from capping research grants, an initiative that President Donald Trump rolled out earlier this year to limit indirect costs tied to biomedical research, such as facilities, equipment and administrative expenses. Kelley had previously delivered a temporary injunction designed to halt the action.
  • The three separate cases were brought forward by 22 states, numerous universities across the country and several trade and healthcare advocacy associations.
  • https://www.fiercebiotech.com/biotech/judge-permanently-blocks-nih-grant-caps-decision-hhs-appealing

Firings at Federal Health Agencies Decimate Offices That Release Public Records

  • Public access to government records that document the handling of illnesses, faulty products, and safety lapses at health facilities will slow after mass firings at the federal Department of Health and Human Services swept out staff members responsible for releasing records, according to transparency advocates and health experts.
  • HHS Secretary Robert F. Kennedy Jr.’s layoffs across health agencies in recent days eliminated workers who handled Freedom of Information Act requests at the Centers for Disease Control and Prevention and cut FOIA staff at the FDA and the National Institutes of Health, said six current and former federal workers KFF Health News agreed not to name because they fear retaliation and are not authorized to speak to the press.
  • At HHS, FOIA requests are used to obtain a litany of records, including detailed CDC information about large outbreaks of food and waterborne illnesses, and FDA inspection reports of facilities that make food, drugs, medical devices, and dental products.
  • https://kffhealthnews.org/news/article/hhs-firings-federal-health-agencies-foia-requests-public-records/

KEY BIOPHARMA NEWS

Biotech CEOs to Cassidy: We're already seeing the effects of FDA's staff cuts

  • Biopharma companies with pending applications at the FDA have “already encountered regulatory difficulties that we believe are the consequences of the FDA’s loss of experienced staff,” more than 100 biotech and VC executives wrote to Sen. Bill Cassidy (R-LA).
  • As chair of the Senate Health, Education, Labor and Pensions committee, Cassidy has jurisdiction over HHS and has already sought a briefing with HHS Secretary Robert F. Kennedy Jr. over the significant cuts.
  • The group of CEOs’ letter from Wednesday raised concerns that the institutional knowledge “that makes the FDA the world’s leading regulatory body will be irretrievably lost” due to the cuts and retirements. The agency has lost many of its senior staff since the Trump administration took over, including the heads of CDER and CBER, the chief medical officer, the principal deputy commissioner and the head of the Office of New Drugs.
  • “We encourage agency leadership to possibly re-hire key people who carry substantial institutional knowledge and lift the FDA’s hiring freeze to ensure all key roles are adequately staffed,” they wrote. “Our companies have already faced delays in scheduling routine meetings and receiving routine agency feedback that guides drug development. Many have concerns that approval decision deadlines will be missed.”

Trump's proposed pharmaceutical tariffs could drive up costs, lead to drug shortages: Experts

  • At a political fundraising dinner on Tuesday night, President Donald Trump said he plans to announce tariffs on pharmaceuticals soon.
  • "We're going to tariff our pharmaceuticals, and once we do that, they come rushing back into our country, because we're the big market," Trump said at the National Republican Congressional Committee dinner in Washington, D.C.
  • "And when they hear that, they will leave China, they will leave other places, because ... most of their product is sold here, and they're going to be opening up their plants all over the place in our country -- we're going to be announcing that," he continued.
  • Although Trump recently implemented a 90-day pause on some tariffs, he said Wednesday he's still serious about putting tariffs on pharmaceuticals to boost U.S. drug manufacturing. "We're going to put tariffs on the pharmaceutical companies, and they're going to all want to come back," Trump said, speaking from the Oval Office.
  • The raw ingredients of almost all medications are made overseas, even for drugs that are manufactured in the U.S., meaning tariffs could drive up the costs of several medications including over-the-counter painkillers as well as antibiotics, heart medications and asthma drugs.
  • Tedeschi said an assessment from The Budget Lab found that a tariff of 25%, for example, would raise pharmaceutical prices by 15% on average.
  • https://abcnews.go.com/Health/trumps-proposed-pharmaceutical-tariffs-drive-costs-lead-drug/story?id=120630296

Congressional commission urges $15B, more action to maintain US biotech advantage over China

  • The report was published Tuesday by the National Security Commission on Emerging Biotechnology (NSCEB), an independent commission that includes two members of the Senate and two from the House of Representatives split by party alongside “seven prominent industry leaders, academic experts, and former government officials from the defense and intelligence communities.”
  • The commission’s main recommendation is for the government to dedicate $15 billion over the next five years to “unleash more private capital into our national biotechnology sector.” This is one of a number of areas where the report's authors argue the U.S. needs to adopt a “more proactive posture” to biotech.
  • The report contains a raft of measures that Congress could enact to “leverage our capital markets to advance national biotechnology priorities.” These include creating “simple pathways” for drugs to market, establishing an investment fund for tech startups that strengthen national security and defining biotechs’ data as “critical infrastructure.” When it comes to accessing these data, the report recommends that the Department of Energy create a single point of entry.
  • https://www.fiercebiotech.com/biotech/congressional-commission-urges-action-maintain-us-biotech-advantage-over-china

Why the closure of an FDA office may impact generics manufacturers — and everyday Americans

  • Amid the hard-to-follow cutbacks at the U.S. Food and Drug Administration, a little-known but important office was eliminated — and the implications will be felt not only by drugmakers, but consumers.
  • The Division of Policy Development in the Office of Generic Drug Policy, which was created more than a decade ago, was responsible for a host of activities that were central to ensuring generic drugs were approved properly for the American market.
  • Now, though, that goal may be in jeopardy.

House panel mulls ways to boost struggling US biosimilar market

  • The state of the US biosimilar market isn’t as healthy as it should be despite significant advances in the past decade, health policy experts told a House panel on Tuesday.
  • The US still struggles to see widespread adoption of biosimilars for some of the world’s most expensive drugs. Experts pointed to a variety of reasons during the hearing of the House Ways and Means subcommittee on health, including PBM and prescriber issues. Lawmakers on both sides of the aisle called for new ways to increase biosimilar access and remove development barriers.
  • “Outdated reimbursement models in Medicare may disincentivize providers to prescribe lower-cost biosimilar products,” Ways and Means health subcommittee chair Vern Buchanan said in his opening remarks. “Additionally, PBMs have perverse incentives to favor high-cost, high-rebate drugs, many times at the expense of patients.”
  • https://endpts.com/house-panel-mulls-ways-to-boost-struggling-biosimilar-market/  (free subscription required for full-text)

Rare disease hub at CDER and CBER faces new reality with staff crunch

  • Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she’s one of only a handful of FDA officials to speak at a live conference since the Trump administration took over.
  • Rick told a crowd of mostly pharma industry employees and analysts at the Biopharma Congress on Monday in Washington that the CDER-CBER joint rare disease hub that she directs is continuing on despite the recent reduction in force.
  • While her team lost only one member to the sweeping job cuts that happened last week, she also noted, “There’s no doubt that the staffing changes that occurred both in February and last week will impact the work of the staff.” She added that the hub’s goals are non-partisan.
  • Rick explained that the goals of the hub are the same as they were when it was first created in July: to centralize and better coordinate the 18 rare disease programs that FDA oversees and to improve internal coordination between CDER and CBER, making their communications more regular and to dispel “seeming inconsistencies” between the two centers.
  • Rick told Endpoints News after her talk that the other members of her team are on loan from CDER and CBER, and that it remains to be seen what the full impact of the staff cuts will mean for the hub.
  • https://endpts.com/rare-disease-hub-at-cder-and-cber-faces-new-reality-with-staff-crunch/   (free subscription required for full-text)

Bipartisan Package to Curb Pharmaceutical Industry Abuses and Lower Drug Prices Wins Senate Judiciary Committee Approval

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA May Fold Digital Health Center Of Excellence Into New Strategic Innovation Office

  • Telehealth stakeholders are working to understand the implications of an FDA plan to fold its Digital Health Center of Excellence (DHCE) with other technology modernization efforts under a new Strategic Programs and Innovation Office, as laid out in a document obtained by Inside Health Policy.
  • While industry lobbyists say increased collaboration among agency offices could boost health technology adoption, whether DHCE is given sufficient staffing levels would impact the new office’s efficiency.
  • https://insidehealthpolicy.com/daily-news/fda-may-fold-digital-health-center-excellence-new-strategic-innovation-office  (subscription required for full-text)

Trump Slashes FDA Digital Health Experts, Likely Limiting New Health Tech Access

  • Just as the Trump administration touts its support for digital health’s role in health care, the Department of Government Efficiency (DOGE) has slashed health technology experts in key FDA offices that help manufacturers gain approval and bring new devices to patients.
  • A health technology expert told Inside Health Policy the mass FDA layoffs have disproportionally impacted artificial intelligence experts, calling into question how emerging AI technologies will gain FDA approval.

KEY MEDTECH NEWS

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

AdvaMed Applauds Reciprocal Tariff Pause; Dems, Med Tech Groups Had Raised Alarms

KEY HEALTH NEWS (Global & US & EOs)

NIH blocks researchers in China, Russia and other countries from multiple databases

CURRENT APPOINTEE STATUS

 https://ourpublicservice.org/performance-measures/political-appointee-tracker/

Updated April 10 at 11 AM EST.

KEY ACRONYMS

  • CADRs = controlled-access data repositories
  • CBER = Center for Biologics Evaluation and Research
  • CDER = Center for Drug Evaluation and Research
  • CMS = Center for Medicare & Medicaid Services
  • DHCE = Digital Health Center of Excellence
  • DOGE = Department of Government Efficiency
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • HHS = Department of Health and Human Services
  • MA = Medicare Advantage
  • NIH = National Institutes of Health
  • NSCEB = National Security Commission on Emerging Biotechnology
  • OHRP = Office for Human Research Protections
  • PBMs = Pharmacy Benefit Managers
  • SACHRP = Secretary's Advisory Committee on Human Research Protections
  • STI = sexually transmitted diseases
  • USPTO = U.S. Patent and Trademark Office

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