Blog | 2/7/2025

Trump Administration Healthcare News: February 7, 2025

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

With any new Executive administration in the United States comes change. The Trump Administration appears unprecedented in the amount of change driving across the entire federal government – in particular in the healthcare arena.

Here at Health Advances, our amazing Library Services team (HALS) has been helping us make sense of the whirlwind, and we’re excited to share those insights with our network. Each Friday for the foreseeable future, we’ll be publishing the “Trump Administration News” highlighting meaningful events across the Executive branch, the HHS agency, relevant departments (including FDA, ASTP/ONC, CMS, and others), and the legislative/judicial branches. We’ll have a particular focus on items as they apply to our work in biopharma and biotech; diagnostics, precision medicine, life science tools and services; medtech; digital health and health IT.

If you have any suggestions or questions, don’t hesitate to reach out!

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 February 6, 2025. The details and broad themes may have changed!

KEY GLOBAL HEALTH NEWS

Trump stops US involvement with UN rights body, extends UNRWA funding halt

  • US President Donald Trump on Tuesday ordered an end to US engagement with the United Nations Human Rights Council and continued a halt to funding for the UN Palestinian relief agency UNRWA.
  • US funding to UNRWA was already frozen, having been so since 2024.
  • Former US President Joe Biden, along with more than a dozen countries, stopped funding the agency in January 2024 after Israel accused 12 of its 13,000 employees of participating in the deadly Hamas attack on Israel on Oct. 7, 2023, which triggered the Gaza war.
  •  The first Trump administration also quit the 47-member Human Rights Council halfway through a three-year term over what it called chronic bias against Israel and a lack of reform. The US is not currently a member of the Geneva-based body. Under former President Joe Biden, the US served a 2022-2024 term.
  • https://www.reuters.com/world/us/trump-signs-orders-iran-withdrawing-us-un-human-rights-council-unrwa-2025-02-04/

KFF analysis: Withdrawing the United States From and Ending Funding to Certain United Nations Organizations and Reviewing United States Support to All International Organizations

  • Stated Purpose: To review United States participation in all international intergovernmental organizations, conventions, and treaties and to withdraw from and end funding to certain United Nations (UN) organizations.
  • Impact: With a long history of multilateral global health engagement, the US is often the largest or one of the largest donors to multilateral health efforts (i.e., multi-country, pooled support often directed through an international organization). It provided $2.4 billion in assessed or core contributions in FY 2024 – 19% of overall US global health funding – as well as more funding in voluntary or non-core contributions.
  • Executive Order: Withdrawing the United States From and Ending Funding to Certain United Nations Organizations and Reviewing United States Support to All International Organizations

KFF analysis: Review of and Changes to USAID

  • Stated Purpose: To review and potentially reorganize USAID “to maximize efficiency and align operations with the national interest”, which may include the suspension or elimination of programs, projects, or activities; closing or suspending missions or posts; closing, reorganizing, downsizing, or renaming establishments, organizations, bureaus, centers, or offices; reducing the size of the workforce at such entities; and contracting out or privatizing functions or activities performed by federal employees
  • Impact: Related to but separate from the Executive Order on reevaluating and realigning foreign aid and on the America first policy directive to the Secretary of State, the administration has made changes to and begun a review of USAID, the US government’s international development agency which oversees and/or implements most US global health programs (see, The US Government and Global Health). Changes to date have included placing senior USAID career staff on leave on January 27 and letting go of hundreds of other staff; taking down the agency’s website on February 2; and closing the USAID building on February 3, which has prevented other staff from accessing it.
  • https://www.kff.org/quick-take/what-is-happening-to-usaid/

KFF analysis: Memorandum For The Secretary of State The Secretary of Defense The Secretary Of Health And Human Services The Administrator of The United States Agency For International Development

  • Stated Purpose: To reinstate Mexico City Policy and direct review of programs per the Kemp-Kasten Amendment.
  • Impact: The Mexico City Policy is a US government policy that – when in effect – has required foreign NGOs to certify that they will not “perform or actively promote abortion as a method of family planning” using funds from any source (including non-US funds) as a condition of receiving US global family planning assistance and, when in place under the Trump administration, most other US global health assistance. First announced in 1984 by the Reagan administration, the policy has been rescinded and reinstated by subsequent administrations along party lines since; it was widely expected that the President Trump would reinstate it in his second term. The new memorandum calls for the implementation of a plan to extend the requirements to global health assistance furnished by all departments or agencies; until the plan is ready, the scope of the new memorandum is unknown.
  • Executive Order: Memorandum For The Secretary of State The Secretary of Defense The Secretary Of Health And Human Services The Administrator of The United States Agency For International Development

Chinese Products Hit with 10% Tariffs

  • On February 1, 2025, President Trump signed Executive Order Imposing Duties to Address the Synthetic Opioid Supply Chain in the People’s Republic of China.
  • On February 3, 2025, US Customs and Border Protection (CBP) issued a Federal Register notice and CSMS# 63988468 – GUIDANCE: Additional Duties on Imports from China following the Executive Order signed by President Trump on February 1, 2025. Both documents provide critical details that importers will need to make customs entries for products made in China and Hong Kong starting February 4.
  • All goods that are products of China, including Hong Kong, will be subject to additional duties of 10% with a few exceptions. Excluded from the tariffs are donations, informational materials, accompanied baggage, some goods claiming Chapter 98, and products that qualify as in-transit according to the details of Harmonized Tariff Schedule of the United States (HTSUS) 9903.01.23 (see below).
  • The new tariffs will be applied using HTSUS 9903.01.20 and are in addition to all other duties, taxes, and fees, including the General Rate of Duty, Section 301 China, antidumping, and/or countervailing duties.
  • Excluded Products: 9903.01.21: Articles the product of China and Hong Kong that are donations, by persons subject to the jurisdiction of the United States, of articles, such as food, clothing, and medicine, intended to be used to relieve human suffering.
  • https://www.nnrglobal.com/insight/chinese-products-hit-with-10-tariffs/

KEY FEDERAL GOVERNMENT NEWS

States secure sweeping temporary restraining order against Trump's federal assistance 'pause'

  • A second federal judge has put the Trump administration's "temporary pause" and review of federal financial assistance on ice, and this time the temporary restraining order is indefinite and much more sweeping.
  • The order, handed down Friday afternoon by Judge John J. McConnell, Jr., of the US District Court for the District of Rhode Island, comes after the Office of Management and Budget (OMB) rescinded a memo outlining a funding freeze that threw much of the country's federal funding recipients into a panic.
  • https://www.fiercehealthcare.com/regulatory/trump-admin-orders-temporary-pause-most-federal-financial-assistance

Trump administration sued over FBI Jan. 6 questionnaires, FDA clinical data removal

  • The third lawsuit was filed by the advocacy group Doctors for America against the Office of Personnel Management, the Health and Human Services Department, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
  • That complaint challenges the abrupt removal Friday from CDC and FDA websites “a broad range of health-related data and other information.”
  • Zach Shelley, an attorney for Public Citizen Litigation Group, which is representing Doctors for America in the suit, told CNBC that “without the information that the CDC and these other agencies have taken down, more people are going to get sick, more people are going to suffer and more people are going to die.”
  • Shelley said that under the Trump administration, “agencies are taking action that undermines their stated mission.”
  • The suit says that data is regularly used by “health professionals to diagnose and treat patients and by researchers to advance public health, including through clinical trials meant to establish the safety and efficacy of medical products.”
  • The removal of the data came two days after Charles Ezell, OPM’s acting director, issued a memo that ordered federal agency heads to “terminate” programs “that promote or inculcate gender ideology” and remove all websites, social media accounts and other media that have that goal.
  • https://www.cnbc.com/2025/02/04/trump-administration-sued-over-jan-6-information-requests-health-data-scrubbing.html
  • Lawsuit document: https://storage.courtlistener.com/recap/gov.uscourts.dcd.277069/gov.uscourts.dcd.277069.1.0_2.pdf

President Trump Issues 10-to-1 Deregulation Executive Order

PAUSED: Imposing Duties to Address the Flow of Illicit Drugs Across Our Northern Border (Trump EO)

  • Key Updates: February 3: Tariffs paused for 30 days. Trudeau announced also said Canada had committed to creating the post of a special czar to combat the smuggling of fentanyl and would ensure permanent monitoring of the shared border.
  • On February 1, President Trump signed executive orders imposing additional tariffs on Canada, Mexico, and China under the International Emergency Economic Powers Act (IEEPA) in response to an emergency declared at the border related to fentanyl, drug trafficking, and illegal immigration concerns.

Canada: The order confirms 25% on “all articles that are products of Canada” as defined in a forthcoming Federal Register (FR) notice, except 10% “energy or energy resources” defined in the same forthcoming FR notice. Sections 2(a), (b).

  • The order confirms that rates are cumulative with all other tariffs that would apply to the imported goods. Section 2(c).
  • No de minimis treatment will be available for shipments under $800 under 19 USC 1321. Section 2(h).
  • No drawback will be available for these duties (but drawback is otherwise still available). Section 2(g).
  • Duty inversion benefits will not be available for the duties under this order with respect to merchandise entered into the United States from foreign trade zones. Section 2(f).
  • No exclusions/exemptions, including for USMCA originating goods, except a very narrow category of items expressly exempted from the President’s authorities under IEEPA in 50 USC 1702(b). Those items include communications, donations intended to relieve human suffering, certain “informational materials,” and “transactions ordinarily incident to travel” like personal baggage. Section 2(j).
  • The order also states that if Canada retaliates, “the President may increase or expand in scope the duties imposed under this order to ensure the efficacy of this action.” Section 2(d).

Retaliatory Actions:

Physicians, families sue President Trump over gender-affirming care ban

  • Physicians with GLMA: Health Professionals Advancing LGBTQ+ Equality, an LGBTQ+ physician association, has joined seven families with transgender or nonbinary children, the American Associate of Physicians for Human Rights and PFLAG, a national LGBTQ+ group, as plaintiffs in a lawsuit over President Donald Trump's executive order to stop federal support for gender-affirming healthcare for transgender people under age 19.
  • The lawsuit was filed in Baltimore Feb. 4 by the American Civil Liberties Union, Lambda Legal, the ACLU of Maryland and law firms Hogan Lovells and Jenner & Block on behalf of two transgender young adults and five transgender adolescents and their families.
  •  The plaintiffs allege that their healthcare has been disrupted by the executive order and call the order "unlawful and unconstitutional," as it seeks to withhold federal funds previously authorized by Congress. It also alleges that the order infringes on the rights of parents and is discriminatory, as the policy does not prohibit federal funds for the same treatments when they're not used for gender-affirming care.
  • https://www.beckersphysicianleadership.com/news/physicians-families-sue-president-trump-over-gender-affirming-care-ban.html?

NIH resumes grant reviews after two-week pause, along with some communications and travel

  • On Tuesday morning, the National Institutes of Health hosted the first study section to review grant applications in over two weeks, following an abrupt and indefinite pause by the Trump administration on Jan. 22. Such meetings — in which expert scientists from around the country consider whether the agency should support proposed research projects — are a core part of how the NIH fulfills its mission to improve human health and reduce illness and disease.
  • https://www.statnews.com/2025/02/04/trump-nih-study-sections-grant-reviews-resume/
  • Note: may require a subscription to read the full-text

Mass retraction of papers submitted to journals

  • Jeremy Faust, MD, reported in his Inside Medicine newsletter on Substack that the CDC has instructed its scientists to retract or pause the publication of any research manuscript being considered by any medical or scientific journal.
  • According to a CDC email reviewed by Faust, the order was to ensure that those manuscripts do not include now-forbidden terms, such as "gender, transgender, pregnant person or pregnant people, LGBTQ, transsexual, nonbinary, assigned male or female at birth, and biologically male or biologically female."
  • Faust reports the order applies to previously submitted manuscripts under consideration and those accepted but not yet published.
  • https://www.cidrap.umn.edu/public-health/removal-pages-cdc-website-brings-confusion-dismay
  • Newsletter link: https://insidemedicine.substack.com/p/breaking-news-cdc-orders-mass-retraction

KEY NEW ENGLAND NEWS

‘Immediately terminate, to the maximum extent’: New England health agencies told to comply with Trump executive orders

KEY BIOPHARMA NEWS

Drug, device makers scramble for tariff exemptions, warn of supply disruptions

  • Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen tensions in medical supply chains and lead to shortages, if their products are not exempted.
  • A statement from the Healthcare Distribution Alliance (HDA), which represents pharmaceutical distributors in the US, stated that tariffs on pharmaceuticals could strain the US pharmaceutical supply chain and urged the Trump Administration to exempt pharmaceuticals from the tariffs.
  • According to USP’s Medicines Supply Map, companies in China, as well as India and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients (API) used in products destined for the US market in terms of locations cited in API drug master files (DMFs) filed with the US Food and Drug Administration (FDA).
  • https://www.raps.org/news-and-articles/news-articles/2025/2/drug,-device-makers-scramble-for-tariff-exemptions

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Some federal health websites restored, others still down, after data purge

  • The Atlas Tool, used by policymakers to track rates of infectious diseases such as HIV and STIs, disappeared but now is back.
  • Pages that explained the Youth Risk Behavior Surveillance System, which monitors adolescent health, were gone but can now be seen again.
  • And the CDC's data site, which was taken offline over the weekend, is back up with datasets available for download.
  • But there is uncertainty about what may be different.
  • An error code for a webpage that can no longer be found.
  •  "Across the country, folks like me are trying to catalogue what is missing and what has changed in terms of what's back up," says Dr. Megan Ranney, an emergency physician and dean of Yale University's School of Public Health.
  • Some of it is obvious, she says — broken links and pages that are no longer there. She's noticed how some pages have been scrubbed of certain words or categories of people. For example, pages on the CDC website that previously referred to "pregnant people" now refer to "pregnant women." But, she notes, researchers are systematically comparing archival data with the updated datasets that have been reposted online.
  • https://www.npr.org/sections/shots-health-news/2025/02/06/nx-s1-5288113/cdc-website-health-data-trump

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Trump administration indefinitely suspends meetings of HHS' health IT advisory committee

  • The Trump administration indefinitely canceled meetings of the Health Information Technology Advisory Committee (HITAC), an advisory panel that helps the federal government establish rules and standards for the use of healthcare data and technologies.
  • The HITAC was established by the 21st Century Cures Act, was enacted in 2016 and began having its first public meetings in 2018.
  • A memo sent out to HITAC members last Wednesday on behalf of Seth Pazinski, director of the Office of Planning, Evaluation, and Analysis for the Office of the National Coordinator for Health IT (ONC), announced that all HITAC meetings, including full committee meetings and task force and work group meetings, are canceled "until further notice." Fierce Healthcare reviewed a copy of the memo.
  • https://www.fiercehealthcare.com/health-tech/trump-administration-indefinitely-suspends-meetings-hhs-health-it-advisory-committee?

Troy Tazbaz, CDRH digital health leader, resigns

  • Troy Tazbaz, director of the Food and Drug Administration’s Digital Health Center of Excellence, said Friday in a LinkedIn post that he is leaving the agency effective immediately.
  • Tazbaz led the digital health center for the last two years, guiding the FDA’s policymaking on artificial intelligence and software as a medical device.
  • The FDA did not respond to a request for comment. The agency has not yet updated the Center for Devices and Radiological Health’s directory to reflect Tazbaz’s departure.
  •  During his tenure, the FDA created a new regulatory framework for updates to medical devices after they go to market. The FDA drafted guidance on pre-determined change control plans in 2023 and finalized guidance last year on changes to AI-enabled devices.
  • Tazbaz also drew out broader plans last year for what regulators will watch for as adaptive models and generative AI come into play. At Advamed’s The MedTech Conference in October, Tazbaz called for a total product lifecycle approach. A month later, the agency fielded advice from patients, physicians and researchers on regulating generative AI in its first digital health advisory committee meeting.
  • https://www.medtechdive.com/news/troy-tazbaz-fda-digital-health-resigns/738951/

KEY MEDTECH NEWS

How New Executive Orders May Affect FDA’s Medical Device Operations

  • Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health products. These executive orders may, for example, delay pending regulations, create uncertainty for FDA’s prior guidance related to artificial intelligence, and adversely impact FDA staffing and resources.
  • Present Trump’s Executive Order on Regulatory Freeze Pending Review requires federal agencies, including FDA, to cease proposing or issuing any rules in the Federal Register “until a department or agency head appointed or designated by the President . . . reviews and approves the rule.”
  •  The rescission of Executive Order 14110 will affect several FDA guidance documents and other resources related to AI. For example, FDA had cross-referenced Executive Order 14110 and used definitions from Executive Order 14110 in the final guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions and the cross-center discussion paper on artificial intelligence and medical products.
  • https://www.morganlewis.com/pubs/2025/02/how-new-executive-orders-may-affect-fdas-medical-device-operations

Trump Transition Updates, Digital Health Picks, and More

  • Software guide tweaked. FDA temporarily took down its 2022 guidance document on clinical decision support software over the past weekend and reposted it on Monday with the word “gender” excised from the document in two spots, but otherwise unchanged.
  •  There was no notification disclosing the edit and the date on the guidance remains listed as September 2022.
  • The edit was likely the result of President Trump’s January 20 executive order directing agencies to remove all references to gender identity as a distinct feature from biological sex, and generally stop using the word gender, in government policies.
  • The guidance describes the factors FDA considers for when CDS software is a regulated device, or when it is not a device, under provisions in the 21st Century Cures Act.
  •   https://www.mystrategist.com/market-pathways/article/trump_transition_updates_digital_health_picks_and_more.html

Drug, device makers scramble for tariff exemptions, warn of supply disruptions

  • Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen tensions in medical supply chains and lead to shortages, if their products are not exempted.
  •  A statement from the Healthcare Distribution Alliance (HDA), which represents pharmaceutical distributors in the US, stated that tariffs on pharmaceuticals could strain the US pharmaceutical supply chain and urged the Trump Administration to exempt pharmaceuticals from the tariffs.
  •  According to USP’s Medicines Supply Map, companies in China, as well as India and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients (API) used in products destined for the US market in terms of locations cited in API drug master files (DMFs) filed with the US Food and Drug Administration (FDA).
  • https://www.raps.org/news-and-articles/news-articles/2025/2/drug,-device-makers-scramble-for-tariff-exemptions

CURRENT APPOINTEE STATUS

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

KEY ACRONYMS

  • CDRH = Center for Devices and Radiological Health
  • CMS = Center for Medicare & Medicaid Services
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • OMB = Office of Management and Budget
  • UNRWA = United Nations Relief and Works Agency
  • USAID = US Agency for International Development
  • WHO = World Health Organization

Share this: