Global Health Watch: Restructuring PEPFAR, Political Control Over Science; FDA + African Medicines Agency MoU

Issue 73

This week, the US Administration continues to move to consolidate control over science, restructure the systems that underpin PEPFAR and global health security, and redefine US global health engagement through regulatory influence rather than long-term public health partnerships.

Restructuring PEPFAR and Weakening the US CDC

The US Administration is moving forward with its plan to significantly reduce the US Centers for Disease Control and Prevention’s (CDC) vital role in PEPFAR and global health programs, shifting much of the authority and funding to the US Department of State, which many argue, does not have the expertise or capacity to manage the programs. In contrast to CDC’s historical role in implementing PEPFAR in-country programs, the plan would require countries to “purchase” CDC technical assistance services (ranging from disease surveillance to laboratory support) through new bilateral agreements in a “fee-for-service” public health model. The future of in-country CDC offices and technical staff is uncertain under this new plan.

The Administration already significantly weakened PEPFAR’s infrastructure by shutting down USAID last year and delaying HIV funding in an interagency transfer to CDC. This new proposal could further undermine the CDC from much of the work that helps deliver HIV services and supports disease detection around the world. As eight former CDC directors – appointed by both Republican and Democratic presidents – warned previously, the proposed restructuring could disrupt not only HIV services but also the laboratory networks, surveillance systems, trained workforce and trusted relationships with ministries of health that support outbreak detection and response worldwide.

IMPLICATIONS: “This will completely destabilize HIV work abroad,” former CDC official Michele Montandon told the New York Times. “We’ve seen service disruptions, deaths and babies born with HIV after shuttering USAID, and we can expect more to come if CDC is also shut out of this work.” The rapid restructuring of PEPFAR could decimate HIV programs, complicate the transition to country ownership, and fracture global disease surveillance and outbreak-response systems built through decades of US investment. While there is broad stakeholder agreement about the importance of increasing country ownership and transitioning away from donor dependence, the accelerated pace and structure of the proposed changes makes technical expertise and relationships precarious before sustainable alternatives are in place. These changes come at a time of a rapidly unfolding Ebola epidemic in Central Africa, complicating current crises and creating doubt in response capacity for future epidemics.

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Political Control Over Science Moves Ahead

The proposed new regulations that would significantly expand political interference in federal funding decisions across all US government grants by the White House’s Office of Management and Budget (OMB) remains at the center of current controversy. In a recent New England Journal of Medicine editorial, editors warned that this Administration is increasingly using budgetary and regulatory tools to bypass longstanding scientific peer-review and congressional processes, including withholding appropriated funds, restructuring federal agencies, and proposing rules that would give political appointees greater influence over research funding decisions. At the same time, Hal Duncan, the nominee to serve as the Deputy Director of the OMB, defended the “pocket rescission” strategy during his confirmation hearings this week in front of Senate leaders. This strategy would allow the Administration to use additional spending cuts through “pocket rescissions,” which would allow funds to expire before Congress has an opportunity to act.

IMPLICATIONS: The moves by OMB signal increasing efforts to shift decision-making authority away from Congress and scientific peer review and toward the Executive Branch, giving the President more control over how federal money is spent and what research and programs get funded in alignment with ideology. For the last 18 months, the question of who gets to decide what scientific research and public health programming are funded and whether Congress’s decisions are carried out as intended continues to be raised, and the answer increasingly appears to be the White House rather than Congress or the broader scientific and public health community.

Scientists Issue Bethesda Declaration: One Year Later

Nearly 40 former and current staff at the National Institutes of Health (NIH) authored a new report, The Bethesda Declaration One Year Later, Continuing Harms to the NIH Mission, which outlines nine deepening concerns at the NIH over the last year along with proposed solutions. This report comes one year after hundreds of NIH employees accused the Administration of politicizing biomedical research through the original Bethesda Declaration. The new report notes that the Administration is slowing medical research, disrupting international collaborations, weakening ethical safeguards, driving away experienced staff and undermining public trust in science. Approximately 24% fewer NIH research projects were funded in 2025 than in 2024 and more than 5,500 peer-reviewed grants were terminated. The report also warns that the White House’s proposed Office of Management and Budget (OMB) rule, which would subject federal grants to greater political review and require alignment with presidential priorities, would institutionalize many of the changes researchers have opposed in the last year.

IMPLICATIONS: The updated Bethesda Declaration shows growing concern from the scientific community about the politicization of science. The NIH has served as the foundation of HIV research, from supporting basic science, vaccine development, implementation of new prevention technologies and global research partnerships. As political oversight expands and international collaboration is deconstructed, the US risks undermining the scientific infrastructure that has fueled decades of innovation and partnership.

US FDA and African Medicines Agency Enter Into New Partnership

The US Food and Drug Administration (FDA) and the African Medicines Agency (AMA) have signed a new Memorandum of Understanding (MoU) to create a shared framework for information sharing and regulatory cooperation. The agreement could allow African regulators to draw on FDA assessments and regulatory decisions when evaluating medical products, while also facilitating greater cooperation on inspections, scientific reviews and regulatory capacity building.

IMPLICATIONS: This agreement between two stringent regulatory authorities (SRAs) is another example of the Administration’s evolving approach to global health and in-line with the US government’s recent “America First” global health strategy. This partnership could be interpreted as a regulatory harmonization effort that would allow for the rapid influx of American-made health technologies for emerging markets in Africa. The expansion and procurement of US-made health commodities is a central feature to the US government’s new transactional approach to global health. However, this comes in stark contrast as the US cuts funding for global health programs, reduces the CDC’s international role and restructures PEPFAR, it is replacing long-term public health partnerships with narrower bilateral agreements focused on regulation and innovation. The disconnect between developing new health technologies and supporting the health systems needed to deliver them complicates the vision for greater regulatory cooperation between SRAs that is required for scale-up and access to the latest treatment and prevention modalities.

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A ‘perilous moment’ for the response to HIV

A new UNAIDS report released ahead of next week’s United Nations General Assembly’s High-Level Meeting on HIV/AIDS shows that external funding cuts, a strong push back on human rights and under investment and under prioritization of HIV prevention and community services are threatening to reverse years of gains in the AIDS response. Read AVAC’s UN High-Level Meeting on HIV/AIDS: What to Watch.

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What We’re Reading

CROI 2025 Cure Reflections Video Series

A PAVE (Pediatric Adolescent Virus Elimination) and REACH video series with HIV cure-related takeaways from CROI 2025.

Speeding Up Access to PrEP

Time from efficacy results to key milestones

The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.

Advocates’ Primer: Understanding Bioequivalence and Pharmacokinetic Studies in Next-Generation HIV Prevention Products

As more next-generation PrEP options become available, HIV prevention research is shifting away from large, multi-year efficacy trials toward pharmacokinetic (PK) and bioequivalence (BE) studies — which test whether a new formulation behaves in the body like a product already proven to work. This primer explains the shift and what it means for advocates.

An Advocates’ Checklist for Lenacapavir for PrEP Introduction

The Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting HIV PrEP developed a new resource that offers practical guidance to help civil society, advocates and implementers accelerate equitable access to LEN for PrEP. The checklist is designed to support faster, community-centered rollout ahead of broader generic availability in 2027.

PrEPWatch: Transforming Data into Action for PrEP Access

AVAC Impact Reports highlight the power of advocacy, research translation, and partnership to advance HIV prevention and global health equity. Read also about how African leadership drives HIV prevention access.

By Grace Tetteh

AVAC’s PrEPWatch is the trusted global repository for comprehensive, user-friendly and up-to-the-minute information about HIV prevention methods. The platform provides data, analysis, tools, and comprehensive resources that are widely used by governments, donors, and partners to inform HIV prevention policy, financing, and programmatic decisions. AVAC ensures that data are available, accessible, and now in partnership with its sister organization, Access Bridge, used to strengthen the efforts of advocates, civil society, policy makers, and funders to translate evidence into action.

Transparent data enables accountability by making gaps visible and actionable, leading to informed global advocacy and decision making that improves equity in PrEP access worldwide. The evidence collected and housed on PrEPWatch, especially through the Global PrEP Tracker, is more critical than ever as the current US administration dismantles USAID and increasingly restricts access to data. In May 2026, AVAC documented the drastic declines in PrEP initiations following cuts to PEPFAR in 2025.

A Brief History of PrEPWatch: Anticipating the results of the tenofovir PrEP trials

In 2005, with early clinical trials of oral tenofovir for PrEP underway and quite controversial, AVAC began tracking the early clinical trials – and the criticisms of them – in the report Will a Pill a Day Prevent HIV? It outlined key information about tenofovir, how it could be used to prevent HIV, tracking details on the status of clinical trials worldwide and surfaced insights, recommendations, and key questions about research ethics, product availability, and equitable access. Critically, it pushed the field to proactively consider and plan for equitable, comprehensive scale-up, should the pill work to prevent HIV.

The report became the foundation for PrEPWatch, which more than two decades later serves as the global resource for information, investigation and documentation for all PrEP products, both approved and in development.

Today, PrEPWatch hosts over 1,000 resources and attracts over 90,000 visitors annually. As the platform expands, so does its recognition as a trusted data source for media outlets, researchers, advocates, and other stakeholders. As Wesley Sundquist, biochemist at the University of Utah and one of TIME’s 100 Most Influential People of 2025 for groundbreaking research leading to the development of lenacapavir for PrEP (LEN), said about resources on LEN rollout: “This information is particularly valuable for me because I don’t follow the latest developments in the rollout nearly as closely as you do; it’s enormously useful for me to hear about this and transmit it accurately.”

The reach and visibility of PrEPWatch demonstrates the broad circulation of essential prevention resources and their fieldwide utility. From a single report 22 years ago, PrEPWatch has evolved into a trusted global resource that supports a broad network of informed stakeholders to engage with data to advance prevention and strengthen the overall HIV response.

Data transparency and accountability promote equity for PrEP access worldwide

One of the most powerful PrEPWatch resources is The Global PrEP Tracker — a comprehensive database with more than 15 years of country-specific data on PrEP initiations, uptake, and regulatory approvals. Updated on a quarterly basis, the dataset enables users to conduct country comparisons and analyses of trends over time, and surfaces insights on progress, setbacks, gaps, and inequities of PrEP availability and access worldwide. This historical and easily accessible dataset is a powerful tool for advocates, policymakers, and implementers to better understand national and regional data as they develop contextually relevant HIV prevention strategies and priorities.

Timely and actionable evidence supports coordinated and accelerated introduction of new prevention tools

As new prevention options emerge, maintaining access to timely, reliable information is critical to ensure effective planning, coordination, and scale-up. Lenacapavir offers the newest and one of the most tangible opportunities to curb the epidemic. It has surpassed previous milestones for the speed of regulatory approvals, guideline development, generic licensing and product introduction compared to previous PrEP products. At every step in the process from disseminating trial results to rollout, PrEPWatch has provided up to the minute resources and information to support LEN introduction and scale-up.

Across the early adopter countries of LEN for PrEP, national governments, supported by advocates, civil society organizations, and donors, used these resources to develop country-specific guidelines, implementation roadmaps, and projections for product demand and supply. As LEN introduction and scale up progresses, PrEPWatch remains essential to ensuring responsive evidence is available to support accelerated roll out, transforming innovation into real-world impact for communities.

“PrEPWatch is an invaluable clearinghouse to access global PrEP guidelines and resources for PrEP implementation. WHO is proud to have their documents included on this one-stop shop.”

—Michelle Rodolph

Leads HIV prevention and PrEP activities, World Health Organization

Sustaining access to credible evidence is a shared responsibility and commitment

PrEPWatch is an open-access platform across the HIV prevention ecosystem built on the collective contributions of partners and collaborators. Data, insights, updates, and resources are shared, synthesized, and translated to ensure accuracy and availability to a wide variety of stakeholders that are shaping policy, driving implementation, and advocating for equitable access to HIV prevention. As the pipeline continues to expand, AVAC and Access Bridge will ensure PrEPWatch remains responsive by providing comprehensive and timely resources that improve product introduction and access.

Analytical Treatment Interruption (ATI)

In this video, from the Series of Jojo, viewers are introduced to a methodology used to assess the efficacy of cure strategies — Analytical Treatment Interruption (ATI). Watch to learn more.

AVAC Infographics for HIV Vaccine Awareness Day

For HIV Vaccine Awareness Day, AVAC’s latest infographics — covering preventive vaccines, bNAbs, the HIV prevention research pipeline, and the impact of US funding cuts — are available as easy-to-use slides.

CROI 2026 Cure Reflections Video Series

Produced by PAVE (Pediatric Adolescent Virus Elimination), this weekly series of videos provides HIV cure-related takeaways from CROI 2026.

More videos forthcoming!

PxWire Volume 16, Issue 2

This issue showcases AVAC’s analysis of the recent PEPFAR data release, assessing how uptake of prevention programs—particularly PrEP initiations—have declined over the last year. As the field grapples with the lasting impact of the US government’s cuts to PEPFAR programs, AVAC takes a closer look at what the data show and what is still missing.

This is especially timely, given the recent announcement from PEPFAR and the Global Fund of their additional commitment to scale-up lenacapavir (LEN) for PrEP. AVAC’s recent infographic unpacks the enduring gap between current donor commitments, LEN volume capacity and potential market size. Lastly, AVAC’s newest infographic depicts the long-acting HIV treatment R&D pipeline. Coupled with research on long-acting prevention and vaccines, long-acting treatment is an important component of an integrated approach to ending HIV as a global health threat.

Read below or download a PDF version of this issue.

Progress in PrEP Uptake

  • On April 17, the US State Department released long-awaited PEPFAR data from the last quarter of Fiscal Year 2025 (FY25), representing the only data available on the status of PEPFAR programs following the US government’s drastic cuts to foreign assistance programs. Only one quarter of data, covering the fourth quarter of FY25 (July-September 2025) was released, and no data are available from the last six months of implementation.
  • While PEPFAR promoted the data release as reflecting significant progress in curbing the epidemic, the data actually reveal stark declines in HIV testing, diagnosis, and treatment. HIV prevention programs were some of the hardest hit by both cuts to PEPFAR programs and the narrowing focus on prevention for pregnant and breastfeeding women (PBFW).
  • In FY25, the number of individuals newly initiated on PrEP decreased by 41% as compared to the same quarter in FY24, with an overall decrease of 54% among all men and 53% among women who are not pregnant or breastfeeding. While PEPFAR touted a 140% increase in PrEP initiation among PBFW, the disaggregated data is historically inconsistent and not available in the latest data release; therefore it cannot be independently verified.
  • Especially worrying was PrEP initiations among adolescent girls and young women (AGYW) aged 15-24, which fell by 39% as compared to a 26% drop among women aged 25-49. AGYW previously benefited from PEPFAR’s DREAMS programs—packages of prevention services to address the high incidence of HIV among AGYW—but the number of program recipients decreased by 86% in FY25 as many of these programs were defunded.
  • Most alarmingly, the data do not include any information on HIV prevention services or PrEP initiation among key populations, including men who have sex with men, transgender people, and sex workers. This lack of data, coupled with the elimination of prevention programs for these populations, reflect an erasure of individuals at high risk for HIV that face life-threatening cuts to services.

Achieving Global 2030 Prevention Targets

The Global HIV Prevention Coalition (GPC) recently launched its HIV Prevention 2030 Global Access Framework, outlining how, by 2030, countries can ensure that 90% of people in need of HIV prevention services have access and that 90% of people living with HIV are virally suppressed. This, in combination, would lead to a 90% reduction in new HIV infections globally. “Innovations, especially lenacapavir, have added to the array of prevention choices. History will judge us harshly if we as a global community fail to meet this scientific moment,” said Mitchell Warren, GPC Co-Chair on a recent webinar. Actions must be country-led, sustainable, people-centered, and rooted in community leadership to achieve these targets.

graphic from UNAIDS report graphic from UNAIDS report

Graphics: HIV Prevention 2030 Global Access Framework

PrEParing for New Products

  • On April 14, the US State Department and the Global Fund announced an increase of their original commitment of LEN for PrEP, from two million to three million people over three years.
  • Gilead has confirmed that it is not supply constrained and can supplement generic supply until it is steady, as long as they receive orders within time, based on their sixto nine-month production lead time needed. Generic supplies are expected to reach the market by the middle of 2027, but their capacity and lead times are not yet known.
  • While this is an important step, it does not go far enough to have meaningful impact on rapid scale-up of LEN, and there are no guarantees that the product will reach those who need it most, including key populations and adolescent girls and young women.
  • AVAC and Access Bridge see more potential to build the market by meeting market demand, leading ultimately to a reduced price, higher annual volumes and significantly increased impact.
  • To achieve this, key priorities over 2026 and 2027 must be advanced:
    • Global Fund and PEPFAR need to raise the floor of their commitment to reach at least four million people in two years.
    • Global Fund must ensure that they have the resources to procure these volumes and meet demand, requiring resource mobilization beyond the recent GC8 replenishment.
    • Global Fund and PEPFAR need to provide clear, transparent LEN access plans, with volumes and countries, ensuring a more comprehensive joint strategy in more countries, as well as volumes and prices with Gilead and generics.
    • All procurers must place orders for 2027 by June 2026 with both Gilead and generics to ensure uninterrupted supply and expanded global access, whether through the Global Fund or directly with manufacturers.
    • Ministries of Health must collaborate with implementation partners and civil society to ensure people-centered approaches to rollout, and to address supply and demand issues as they emerge and develop robust forecasts for 2027.
    • Generic manufacturers must specify their lead-times from order to delivery to coordinate and ensure timely procurement.
    • Gilead must urgently finalize license and supply agreements for middle-income countries, especially in Latin America and Asia.

The Latest in the HIV Research Pipeline

  • AVAC has recently begun to track the research pipeline for long-acting HIV treatment (LA-ART). This focus aligns with AVAC’s work to advance an integrated approach to ending HIV transmission, including a comprehensive agenda for the development of novel and longer-acting products beyond PrEP, inclusive of PEP and treatment.
  • A rapidly expanding pipeline for LA-ART has the potential to introduce new regimens with dosing frequencies that range from weeks to months to, eventually, years. The benefits of LA-ART include reduced drug dosing, frequency, and number of drugs, with the potential for associated decreases in the cost of medications and the burden on health systems. New drug classes could close treatment gaps in children, adolescents, and those with high viremia, comorbidities and resistance.
  • CROI 2026 highlighted the potential future LA-ART landscape beyond today’s 2-month CAB + RPV injections. The range of products in development includes novel characteristics such as new ART classes and monoclonal antibodies, new ARV combinations, delivery via oral, implantable and injectable formulations, and longer regimens—currently up to six-months.
  • Ongoing clinical research will hopefully further demonstrate whether there are trade-offs (treatment failures or resistance) between LA-ART and highly effective daily oral ART. In addition to the new long-acting products, simplified single-tablet daily regimens are also in development.

Building the Market for New Products from the Trial Stage

MK-8527 is currently in Phase III trials (EXPrESSIVE-10 and EXPrESSIVE-11) across 17 countries. To build a supportive environment around the concept of a monthly oral PrEP pill, AVAC supported the development of communications materials for use in the EXPrESSIVE-11 trial which can be adapted for future market entry. AVAC worked with local partners and MSM, transgender, and non-binary communities in 8 trial countries in Africa, Asia, and Latin America to co-create the materials, ensuring that focus populations contributed to the design. The result is a global campaign with a localized feel that is generating awareness on MK-8527 early.

English poster example
Portuguese poster example
Spanish language poster
Swahili language poster

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