Blog | 5/9/2025

Trump Administration Healthcare News: May 9, 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 May 8, 2025. The details and broad themes may have changed.

 

KEY HEALTH NEWS (Global)

UNAIDS to slash workforce by more than half as funding by US and other big donors disappears

  • The U.N. agency that fights HIV plans to slash its workforce by more than half and move many posts to cheaper locations as a result of drastic funding cuts from longtime donors in the United States, Asia and Europe, the agency and staffers told The Associated Press on Tuesday.
  • UNAIDS said “the overall global AIDS response is facing a severe shock and many of the gains made in the past few decades are at risk of being reversed.” It said the restructuring follows an independent panel’s recommendations calling for “downsizing” its secretariat in Geneva while continuing to “prioritize the most essential functions.” It said it would maintain its presence in 36 countries.
  • Drastic U.S. cuts in assistance under the current Trump administration, part of wider cuts for global health, strike perhaps the biggest blow ever to the world’s efforts to fight HIV.
  • Employees were told at an internal town hall Tuesday that staff will be reduced to about 280 to 300 from about 600 currently, participants said.
  • UNAIDS officials were considering plans to move many posts to lower-cost locations where it already has offices: in Bonn, Germany; Nairobi, Kenya; or Johannesburg, South Africa — the country with the world’s highest number of AIDS cases, agency spokesperson Charlotte Sector told the AP.
  • https://apnews.com/article/united-states-trump-unaids-cuts-hiv-health-a5856416fbf093088e60daf5b4dd955f

NIH tightens reins on subawards, ending the process for foreign recipients

  • The National Institutes of Health (NIH) is making a major change to how grant recipients can use their funds. The agency plans to end the subaward process that has been under increased scrutiny since the beginning of the COVID-19 pandemic.
  • The policy will first only impact subaward recipients outside of the U.S., the agency said in a notice published May 1, with the goal of eventually expanding to include domestic subawards as well. 
  • A subaward occurs when a grant recipient redirects some of their received funds to a third party, like a research group at another university, which then carries out part of the grant’s work. 
  • “NIH is establishing a new award structure that will prohibit foreign subawards from being nested under the parent grant,” the agency said in the notice. 
  • Press:  https://www.fiercebiotech.com/research/nih-disallow-grantees-issuing-subawards-starting-foreign-recipients
  • Notice: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-104.html

KEY FEDERAL GOVERNMENT NEWS

Trump releases 2026 budget including heavy healthcare cuts

  • The White House released a 2026 budget on Friday that includes steep cuts to healthcare programs, particularly those housed in the Centers for Disease Control and Prevention and the National Institutes of Health, continuing the Trump administration’s broadside against biomedical research and public health funding.
  • The cuts are necessary to reduce fraud, waste and abuse at HHS agencies, many of which have backed programs opposed by the president, such as researching gender-affirming care for transgender individuals or publishing information on climate change, White House officials said in the budget document.
  • The president’s budget is a wish list and holds no weight on its own, though Congress often takes the blueprint into account when allocating funding for the upcoming year.
  • The 40-page request sent to Congress by Office of Management and Budget Director Russell Vought includes a 23% cut to the government’s discretionary funding and a 13% increase in military spending overall.
  • If enacted, the HHS would have its discretionary funding cut by 26%.
  • Under the budget, the NIH would lose almost $18 billion — the largest proposed cut for an HHS division in the blueprint. The NIH would also reorganize its variety of programs into five specific areas: the National Institute on Body Systems Research; National Institute on Neuroscience and Brain Research; National Institute of General Medical Sciences; National Institute of Disability Related Research; and National Institute on Behavioral Health.
  • Funding for the National Institute on Minority and Health Disparities and centers focusing on nursing research, global health and alternative medicines would be entirely eliminated.
  • Meanwhile, the CDC would lose $3.6 billion. Programs that are “duplicative,” “DEI” or “simply unnecessary” would be eliminated, including the National Center for Chronic Diseases Prevention and Health Promotion, the National Center for Environmental Health and the National Center for Injury Prevention and Control.
  • The CDC’s public health preparedness programs would also be shut down, as they “can be conducted more effectively by States,” according to the budget.
  • As for other HHS agencies, the Health Resources and Services Administration, which works to improve healthcare for underserved populations, would lose $1.7 billion, while the Substance Abuse and Mental Health Services Administration, which focuses on improving U.S. mental health and combating substance use disorders, would lose $1 billion.
  • The CMS, which oversees health insurance programs for some 150 million Americans, would lose almost $700 million, focused in areas like health equity and beneficiary outreach and education.
  • “This cut will have no impact on providing benefits to Medicare and Medicaid beneficiaries,” the budget says.
  • The HHS’ only funding increase in the budget would be for “MAHA,” or “Make America Healthy Again,” initiatives like promoting nutrition and exercise, a key focus of HHS Secretary Robert F. Kennedy, Jr. Such programs would receive $500 million next year.
  • Press: https://www.healthcaredive.com/news/trump-white-house-budget-healthcare-hhs-cuts/747062/
  • White House statement: https://www.whitehouse.gov/briefings-statements/2025/05/the-white-house-office-of-management-and-budget-releases-the-presidents-fiscal-year-2026-skinny-budget/
  • White House budget request: https://www.whitehouse.gov/wp-content/uploads/2025/05/Fiscal-Year-2026-Discretionary-Budget-Request.pdf

Medicaid cuts could cost 10 states, DC nearly $500B: Report

  • Ten states and Washington, D.C., could face a $468 billion shortfall over the next decade if Congress reduces the amount it guarantees states to run their Medicaid programs, according to a May 6 report from the Urban Institute and the Robert Wood Johnson Foundation.
  • The federal government has paid for at least half of every state’s Medicaid costs through the Federal Medical Assistance Percentage, which starts at a floor of 50%, according to the report. If that floor were reduced, 10 states and the district would be affected.
  • Researchers found that the proposed change would result in significant cuts in Medicaid support for people with disabilities ($189.5 billion), older adults ($161.1 billion), and children ($50.1 billion) across the affected states and Washington, D.C
  • To maintain existing Medicaid coverage, researchers said, states would need to drastically raise their Medicaid budgets — ranging from a 4.1% increase in Maryland to a 63.2% increase in Washington, D.C.
  • If combined with other proposed federal Medicaid cuts — such as eliminating support for expanded eligibility — the total loss in federal aid to these states and D.C. could reach $835 billion over the next 10 years, according to the report.
  • https://www.beckershospitalreview.com/finance/medicaid-cuts-could-cost-10-states-dc-nearly-500b-report/

Kennedy Announces New Database for Research Into ‘Root Causes’ of Autism

Trump administration has shut down CDC's infection control committee

  • The Trump administration has terminated a federal advisory committee that issued guidance about preventing the spread of infections in health care facilities. 
  • The Healthcare Infection Control Practices Advisory Committee (HICPAC) crafted national standards for hand-washing, mask-wearing and isolating sick patients that most U.S. hospitals follow.
  • Four committee members said the Centers for Disease Control and Prevention delivered the news about HICPAC’s termination to members Friday. 
  • A letter reviewed by NBC News — which members said the CDC sent out after a virtual meeting — says the termination took effect more than a month previously, on March 31. According to the letter, the termination aligns with President Donald Trump’s executive order calling for a reduction of the federal workforce. 
  • Four professional societies previously asked Health and Human Services Secretary Robert F. Kennedy Jr. in a letter on March 26 to preserve the committee amid widespread cuts to federal health agencies.
  • The CDC and the Department of Health and Human Services did not immediately respond to a request for comment Tuesday.
  • https://www.nbcnews.com/health/health-news/trump-administration-shut-cdcs-infection-control-committee-rcna205209

250 more NIH workers laid off, including cuts at the National Cancer Institute

  • The National Institutes of Health (NIH) has laid off 250 more employees, with this round of cuts hitting 50 workers at the National Cancer Institute (NCI).
  • “Guided by President Trump’s Executive Order, the department remains focused on cutting wasteful bureaucracy, eliminating duplicative administrative roles and allowing HHS to redirect resources where they’re most needed—delivering better outcomes for the American people,” a spokesperson for the Department of Health and Human Services told Fierce Biotech over email.
  • “HHS provided notification to approximately 250 new employees that they are being impacted by the reduction in force announced on March 27,” the spokesperson added, saying the notices were delivered on May 2.
  • https://www.fiercebiotech.com/biotech/250-more-nih-workers-laid-including-cuts-national-cancer-institute

States sue US over plan for reorganization of federal health agencies

  • Attorneys general from 19 states and Washington, DC have filed a lawsuit against the federal government alleging that its plan for a broad restructuring of health agencies is “an unlawful effort to undercut the will of Congress.”
  • The lawsuit, filed on Monday in the US District Court for the District of Rhode Island, challenges a March announcement that called for HHS to consolidate 28 divisions into 15, and to reduce staff by 10,000 full-time employees. HHS said at the time that the action, alongside other efforts, would lead to a total reduction in force of about 20,000 staffers.
  • While HHS has said the cuts would make the agency “more efficient and more responsive to Americans’ needs,” the states argued that “the consequences are severe, complicated, and potentially irreversible.” They asked the court to determine that the March directive is unlawful, and to “preliminarily and permanently enjoin” the government from implementing it.
  • https://endpts.com/states-sue-us-over-plan-for-reorganization-of-federal-health-agencies/   (subscription required for full-text)

FDA's top inspector abruptly retires

  • The Food and Drug Administration's top official overseeing drug and food safety inspections told staff on Monday he has decided to leave the agency, and multiple federal health officials told CBS News it comes amid frustration from inspectors with the FDA's new commissioner.
  • Michael Rogers had worked for the FDA for more than three decades, culminating in a role as the agency's associate commissioner for inspections and investigations. Colleagues said they were surprised to learn that his final day in the office will be May 14.
  • "I have decided to retire. It was my decision, but it was time after 34 years," Rogers told CBS News in an email on Monday.
  • Rogers has had a challenging tenure atop the agency's inspections workforce. He was the top official overseeing food inspections during the infant formula crisis in 2022,  when the agency mishandled whistleblower complaints about a troubled formula plant linked to a deadly recall. He also oversaw a resulting reorganization of the FDA's inspections office in 2024.
  • Two FDA officials, who spoke on the condition of anonymity, said Rogers had told colleagues privately that he was miserable in recent days, as the agency's inspections office has reeled from sweeping cuts to its ranks ordered by Health and Human Services Secretary Robert F. Kennedy Jr.
  • https://www.cbsnews.com/news/fda-top-inspector-michael-rogers-abruptly-resigns/

Trump nominates Casey Means, entrepreneurial doctor and MAHA leader, for surgeon general

  • The health entrepreneur and “Make America Healthy Again” leader Casey Means has been nominated to be the U.S. surgeon general after President Trump pulled his prior nominee suddenly on Wednesday.
  • Means, an M.D. and author who runs a holistic wellness blog and co-founded the health tech company Levels, is the sister of Calley Means, an adviser to Health Secretary Robert F. Kennedy Jr. Both Meanses have become key influencers in the MAHA world, with Casey lending her medical training and knowledge to the cause.
  • Trump’s original nominee to the post of surgeon general was Janette Nesheiwat, a medical doctor and Fox News contributor. The White House withdrew her nomination a day before Nesheiwat was scheduled to appear before a key Senate committee. She came under fire in recent weeks for previous comments she’d made online in support of the Covid vaccine and masking during the pandemic. CBS News also reported that Nesheiwat received her medical degree from a school in the Caribbean, not, as she claimed, the University of Arkansas School of Medicine.

FDA taps critic of COVID policies, drug industry to lead vaccines division

  • The Food and Drug Administration (FDA) has tapped Vinay Prasad, a prominent critic of federal COVID-19 policies and a proponent of more stringent approval standards, to lead the agency’s vaccines division.
  • Prasad replaces Peter Marks, the longtime leader of the Center for Biologics Evaluation and Research (CBER), who resigned in March after clashing with Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
  • “Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER — a significant step forward,” FDA Commissioner Martin Makary posted on the social platform X on Tuesday.
  • Prasad was previously an epidemiology professor at the University of California, San Francisco. He graduated medical school at the University of Chicago and has a master’s degree in public health from Johns Hopkins University. He is an oncologist and hematologist by training.
  • Prasad is the latest of a series of medical contrarians and critics of COVID-19 measures to join Kennedy’s HHS. 
  • https://thehill.com/policy/healthcare/5286050-fda-taps-vinay-prasad-leader/

FDA names first-ever AI chief

  • Jeremy Walsh is now heading up artificial intelligence and information technology in a newly created position at the FDA. He announced the move on LinkedIn.
  • Walsh comes from the government contractor Booz Allen Hamilton, where he worked for 14 years and was chief technologist, building out cloud networks and data analytics systems for the agencies the firm works with, Ruth reports.
  • While at Booz Allen, Walsh worked on contracts with the FDA, the CDC, the NIH, Veterans Affairs and military health services.
  • This is the first time the FDA has appointed a chief AI officer. Former chief information officer Vid Desai managed IT for the agency.
  • Walsh arrives at the FDA amid major workforce cuts. Among the losses have been key tech talent, including Sridhar Mantha, former director of strategic programs at the Center for Drug Evaluation and Research. He co-chaired the AI Council at CDER and helped develop policy around AI’s use in drug development.
  • Walsh could try to make the FDA more efficient by looking for areas where he can combine similar or redundant databases across the agency centers, said a source familiar with Walsh and granted anonymity to share insights on his thinking.
  • https://www.politico.com/newsletters/prescription-pulse/2025/05/06/fda-names-first-ever-ai-chief-00330461

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

  • In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
  • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
  • The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
  • To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.
  • Looking ahead, the FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.
  • The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer and Sridhar Mantha.
  • https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai

Democrats introduce resolution demanding transparency in HHS

  • Congressional Democrats are attempting to hold HHS Secretary Robert F. Kennedy Jr. to his promise of “radical transparency,” demanding Kennedy cease a new HHS policy of promulugating changes without always allowing public notice or an opportunity for public comment.
  • Kennedy said earlier this year the department would break longstanding precedent of giving notice and accepting public comments about policy changes.
  • https://www.healthcaredive.com/news/democrats-introduce-resolution-demanding-transparency-hhs/747053/

RFK Jr. asks CDC for new measles treatment guidance amid his unfounded claims

  • Health and Human Services Secretary Robert F. Kennedy Jr. will ask the Centers for Disease Control and Prevention to develop new guidance for treating measles with drugs and vitamins, an HHS spokesperson said.
  • The move comes as Kennedy has faced criticism during this year's record measles outbreaks for remarks misleading people into thinking that measles infections are easily curable and inflating myths about measles vaccines. Vaccination is the only way to prevent the highly infectious disease that can cause serious health complications or death in some cases.
  • "Secretary Kennedy will be enlisting the entire agency to activate a scientific process to treat a host of diseases, including measles, with single or multiple existing drugs in combination with vitamins and other modalities," the HHS spokesperson said in a statement to CBS News.
  • The statement said the CDC effort would involve working with universities "to develop protocols, conduct testing, and pursue approval for new uses of safe and effective therapeutics that meet the highest scientific standards."
  • While the CDC is continuing to recommend vaccination "as the most effective way to prevent the disease," the statement says they recognize some Americans "may choose not to vaccinate."
  • https://www.cbsnews.com/news/rfk-jr-cdc-measles-treatment-guidance/

Trump's new executive order targets gain-of-function research, citing unsupported 'lab leak' theory

  • President Donald Trump is continuing to promote the unsupported “lab leak” COVID-19 theory, using it now to rationalize a new executive order designed to prohibit federal funding of certain research on pathogens abroad and severely limit such research in the U.S.
  • The May 5 order, titled “Improving the Safety and Security of Biological Research,” calls on agencies to “end federal funding of dangerous gain-of-function research” in "countries of concern," plus other countries deemed to lack sufficient U.S. oversight.
  • The order also sets out to block federally-funded life science research occurring in these countries that “could reasonably pose a threat to public health, public safety and economic or national security.”
  • The only “country of concern” specifically mentioned in the order is China. In an April 2 measure blocking access to U.S. research data, the Trump administration used “countries of concern” to refer to China, Hong Kong, Macau, Russia, Iran, North Korea, Cuba and Venezuela.
  • Trump’s order also instructs federal agencies to revise or replace a Biden policy from 2024 that governs oversight of national gain-of-function research, calling for increased top-down scrutiny of federally funded work. Trump's order also calls for agencies to “develop and implement a strategy to govern, limit and track non-federally funded gain-of-function research” in the U.S.
  • Press: https://www.fiercebiotech.com/research/trump-executive-order-restricts-gain-function-research-citing-unsupported-lab-leak-covid
  • Executive Order: https://www.whitehouse.gov/presidential-actions/2025/05/improving-the-safety-and-security-of-biological-research/

KEY REVERSALS – RESCINDED ITEMS

House GOP backing off some Medicaid cuts as report shows millions of people would lose health care

  • House Republicans appear to be backing off some, but not all, of the steep reductions to the Medicaid program as part of their big tax breaks bill, as they run into resistance from more centrist GOP lawmakers opposed to ending nearly-free health care coverage for their constituents back home.
  • This is as a new report out Wednesday from the nonpartisan Congressional Budget Office estimated that millions of Americans would lose Medicaid coverage under the various proposals being circulated by Republicans as cost-saving measures.
  • House Republican lawmakers exiting a meeting late Tuesday evening indicated that Johnson and the GOP leadership were walking away from some of the most debated Medicaid changes to the federal matching fund rates provided to the states.
  • Rep. Jeff Van Drew, R-N.J., said those Medicaid changes “are dead.”
  • While those changes would bring in billions of dollars in cost savings, they would also result in roughly 10 million people losing Medicaid coverage, the CBO said.
  • They appear to be off the table.
  • But other proposed Medicaid changes are still in the mix for Republicans, including imposing new limits on a state’s tax on health care providers that generate larger payments from the federal government.
  • https://apnews.com/article/medicaid-cuts-trump-tax-bill-house-gop-257e1d90a69059dcf8c7b23cb6eefa69

CDC disease detectives exempted from Trump hiring freeze, averting cut to program

  • The Department of Health and Human Services has granted an exemption to the Centers for Disease Control and Prevention to hire a new class of its disease detectives, multiple CDC officials said, averting a feared halving of the highly selective fellowship.
  • Each year, the CDC usually hires a new class of its Epidemic Intelligence Service officers to replace those graduating from the agency's two-year program.
  • Nicknamed the CDC's "disease detectives," officers are often dispatched around the country to support the agency's response to investigating outbreaks and other health emergencies, or assigned to work with CDC teams or health departments.
  • "HHS granted the CDC an exemption to onboard and train newly selected EIS officers. EIS officers continue to investigate outbreaks, analyze public health data, respond to emergencies, and support health departments worldwide," an HHS spokesperson said in a statement.
  • The fate of the program had worried CDC officials, amid a sweeping federal hiring freeze that has halted most efforts to add new staff to the agency. Most officers need to move to a new location to serve in the program, ahead of a June 30 start date.
  • https://www.cbsnews.com/news/cdc-disease-detectives-trump-hiring-freeze-exemption

Trump pulls surgeon general nominee

  • President Trump has pulled his nomination of Janette Nesheiwat to be U.S. surgeon general and has instead chosen chronic disease entrepreneur Casey Means, a physician with close ties to the “Make American Healthy Again,” or MAHA, movement, as his new pick to fill the role.
  • Nesheiwat’s credentials came into question last month when CBS News reported that records showed she had graduated from the American University of the Caribbean School of Medicine, and not the University of Arkansas School of Medicine, as had been said when her nomination was announced.
  • The physician and former Fox News contributor also got on the wrong side of influential Trump supporters including MAGA influencer Laura Loomer.
  • The Senate Committee on Health, Education, Labor and Pensions was scheduled to hold a hearing Thursday on Nesheiwat’s confirmation.
  • Means, a graduate of Stanford Medical School, is the sister of Calley Means, a close ally to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and a special government employee at HHS. They are both high-profile proponents of Kennedy’s MAHA agenda.
  • https://thehill.com/policy/healthcare/5288601-trump-nominee-casey-means-surgeon-general/

Accelerating Access to Research Results: New Implementation Date for the 2024 NIH Public Access Policy

  • The 2024 Public Access Policy, originally slated to go into effect on December 31, 2025, will now be effective as of July 1, 2025.
  • To be clear, maximum transparency regarding the research we support is our default position. Since the release of NIH’s 2008 Public Access Policy, more than 1.5 million articles reporting on NIH-supported research have been made freely available to the public through PubMed Central. While the 2008 Policy allowed for an up to 12-month delay before such articles were required to be made publicly available, in 2024, NIH revised the Public Access Policy to remove the embargo period so that researchers, students, and members of the public have rapid access to these findings.
  • https://www.nih.gov/about-nih/who-we-are/nih-director/statements/accelerating-access-research-results-new-implementation-date-2024-nih-public-access-policy

In Reversal, FDA Rehires Staff Tasked With Releasing Public Records

  • The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory activities, two employees said. The recall reverses firings carried out roughly a month ago by the Department of Health and Human Services, which oversees the agency.
  • Workers who process records about medical device and tobacco regulation under the Freedom of Information Act received notices from an FDA official May 1 that they were no longer being fired as part of the department’s mass layoffs, according to the employees and documents reviewed by KFF Health News, which agreed not to name the workers because they are not authorized to speak to the press and fear retaliation.
  • The workers were told to return to their jobs immediately.
  • A notice from FDA to an affected FOIA staffer said the HHS’ “Reduction in Force” was being rescinded but did not provide a rationale for reinstatement, according to a copy viewed by KFF Health News. However, the worker said an FDA official had told them their job was “mission critical.”
  • Two current or former employees noted that the FDA missed several court-ordered deadlines to produce documents in April. Other FOIA workers were told they were being reinstated, two employees said.
  • HHS officials didn’t respond to a request for comment.
  • https://kffhealthnews.org/news/article/fda-rehires-foia-staff-public-records-requests-layoffs-trump-hhs/

KEY BIOPHARMA NEWS

Trump signs executive order to boost US drug manufacturing amid threat of tariffs

  • In President Donald Trump’s latest push to bring pharmaceutical manufacturing to the U.S., a new executive order tasks the FDA with reducing regulatory hurdles for domestic producers while making life harder for foreign manufacturers.
  • The new executive order, signed on Monday, asks the FDA to “reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants.”
  • In the meantime, the order directs the FDA to “increase fees for and inspections of foreign manufacturing plants.”
  • To benefit domestic manufacturers, Trump is asking the FDA to eliminate “duplicative and unnecessary requirements,” to streamline reviews and to “provide early support before facilities come online.”
  • New FDA Commissioner Marty Makary, M.D., appears on board with the order and is prepared to act on it.
  • https://www.fiercepharma.com/pharma/trump-signs-executive-order-boost-us-drug-manufacturing-amid-tariff-threats

Bipartisan senators offer new bill aimed at lowering drug prices

  • A bipartisan pair of senators introduced legislation to lower prescription drug prices by prohibiting pharmaceutical companies from selling drugs in the U.S. at higher prices than the international average.
  • The bill from Sens. Josh Hawley (R-Mo.) and Peter Welch (D-Vt.) is a riff on the “most favored nation” policy President Trump pushed in his first term, which tried to tie domestic prices for certain prescription drugs in Medicare to the lowest level paid by comparable countries.
  • Drug companies sued shortly after the effort was launched as an interim final rule, and it was blocked in federal court. 
  • The White House is seeking to revive the policy as part of the broader GOP discussions on paying for his domestic policy legislation, though the newest version would only apply to Medicaid and not Medicare, the White House confirmed to The Hill. 
  • It’s not clear how much savings could be gained, as federal law already requires Medicaid to pay the “best price,” a steep discount from the lowest price available on the private market. 
  • https://thehill.com/policy/healthcare/5283776-bipartisan-senators-offer-new-bill-aimed-at-lowering-drug-prices/

FDA will convene vaccine advisors to discuss Covid strain updates

  • FDA advisors will meet later this month to discuss which Covid-19 strain vaccine makers should target ahead of the the fall and winter, when infections tend to spike.
  • The May 22 meeting, disclosed in a federal register notice, is seen as an indicator of the FDA’s appetite for updating the shots under the new administration. Meeting notices are usually published at least 15 days before the scheduled time, but the government said it couldn’t meet that deadline because of “technical issues.”
  • An earlier February meeting of the Vaccines and Related Biological Products Advisory Committee to discuss flu vaccine strains was canceled, and the decision on strains was made privately by FDA officials.

PhRMA says tariffs are 'not the answer' as industry trade probe closes for comments

  • A leading pharmaceutical trade group urged the Department of Commerce not to place tariffs on the sector as the window for feedback on the trade probe draws to a close.
  • “Tariffs are not the answer for promoting greater domestic production of these products. On the contrary, every dollar collected in tariffs would be a dollar less that innovative biopharmaceutical companies are able to invest in US R&D, manufacturing facilities and infrastructure,” PhRMA said in a 40-page comment.
  • President Donald Trump is one step closer to implementing potential pharma levies as the public comment period on the Section 232 investigation ends at midnight on Wednesday. Trump said on Monday, during the signing of a new executive order, that he will make an announcement on the tariffs in the “next two weeks.”
  • PhRMA’s letter is currently the only comment that has been made public, yet in total there are at least 241 comments submitted for the pharma probe.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Trump’s Budget Cuts CISA Funding That Supports Health Care Cybersecurity

KEY MEDTECH NEWS

RFK’s FDA layoffs could slow safety communications, experts warn

  • Mass staff cuts at the Food and Drug Administration could affect public notices about medical device recalls and other product safety issues, experts told MedTech Dive.
  • Many communications staff in the FDA’s Center for Devices and Radiological Health were cut in early April after the Department of Health and Human Services unveiled a plan to lay off about 10,000 employees.
  • Some employees affected by the layoffs were responsible for writing public notices on safety issues and certain high-risk medical device recalls.
  • “There is ‘nobody’ to work on the communications side of issues with medical devices,” the former CDRH staffer said.
  • Another former CDRH worker knew of one communications official who still reports to Tarver, but believed the other communications staff in the device center were let go.
  • HHS Secretary Robert F. Kennedy Jr., in late March, said the department would cut 10,000 people, including about 3,500 full-time FDA workers. Staff began receiving layoff notices on April 1. The Office of Communication, Information Disclosure, Training and Education was among the groups affected at the CDRH.
  • The FDA has continued to update its recall database, which provides short, technical descriptions of recalls, but has posted fewer recall notices and early alerts, which provide more detailed information, since the March staff cuts.
  • https://www.medtechdive.com/news/fda-layoffs-slow-safety-communications-recalls/747276/

AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

  • AdvaMed and its British counterpart have called for reciprocal “zero for zero” tariffs on medtech products traded between the U.S. and U.K.
  • The trade groups, writing in a joint statement Tuesday, warned procurement times slipped in the first week of the tariffs but said “there is still time to ensure it does not devolve into a crisis.”
  • AdvaMed and the Association of British HealthTech Industries’ (ABHI) want zero tariffs and for the U.K. to accept Food and Drug Administration regulatory approvals and clearances.
  • AdvaMed and ABHI also argued that tariffs on medical devices will not be a net positive for the finances of governments that impose the taxes. The trade groups said the medtech industry is unique because the largest payers are governments. As such, “any national revenue raised through tariffs could be offset by higher costs to the taxpayers who fund those programs,” AdvaMed and ABHI said.
  • The trade groups said the U.K. and U.S. should take two steps to “successfully navigate the turbulence” and avoid the negative outcomes they foresee. First, the U.S. should agree to impose no tariffs on medtech imports from the U.K., and vice versa. The zero for zero tariff proposal echoes earlier calls made by Medtech Europe, the trade groups’ counterpart in the European Union, and AdvaMed itself.
  • https://www.medtechdive.com/news/AdvaMed-UK-ABHI-zero-tariffs/747343/

KEY ACRONYMS

  • ABHI = Association of British HealthTech Industries
  • AI = artificial intelligence
  • CBER = Center for Biologics Evaluation and Research
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • CISA = Cybersecurity and Infrastructure Security Agency
  • CMS = Center for Medicare & Medicaid Services
  • EIS = Epidemic Intelligence Service
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • GOP = Grand Old Party (Republican Party)
  • HHS = Department of Health and Human Services
  • HICPAC = Healthcare Infection Control Practices Advisory Committee
  • MAGA = Make America Great Again
  • MAHA = Make America Healthy Again
  • NCI = National Cancer Institute
  • NIH = National Institutes of Health
  • OMB = Office of Management and Budget
  • PhRMA = Pharmaceutical Research and Manufacturers of America

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