Global Health Watch: A New Congress and a New Cadre of Scientific Leadership, US FDA Approves Generic LEN, Future of Global Fund

November 6, 2026

The US midterm elections this week brought significant changes to Congress, creating both new opportunities and uncertainties for the future of science, global health and HIV. This is a moment that is both “celebratory and scary,” with much to unpack about what a new Congress will mean for US policies and investments. With potentially more than 100 new members taking office in January, the need for education, engagement and advocacy will be critical to securing supportive policies and sustainable funding for US-led global health programs and research.

This issue examines what the election results mean for science and global health, the US FDA regulatory approval of generic lenacapavir for HIV PrEP (LEN), and Mark Dybul’s vision for the Global Fund amid shrinking resources and shifting priorities.

US Midterm Elections: A New Congress and a New Cadre of Scientific Leadership 

Tuesday’s midterm elections in the US brought seismic shifts to Congress, creating new legislative opportunities to strengthen oversight, protect investments in science and public health, and shape the future of US global health engagement. Democrats won control of both chambers of Congress, opening new avenues for congressional oversight and challenges to the administration’s science and health policy agendas. The election also brought a new wave of lawmakers with backgrounds in science, medicine and public health. The organization 314 Action, which supports Democratic candidates with science backgrounds, “hailed the victories as a ‘STEM wave,’” noting that the first Democratic physicians since the 1960s were elected to the Senate. Among the newly elected lawmakers are Congresswoman-elect Jasmine Clark of Georgia, a microbiologist and professor who has identified restoring federal scientific research funding as a priority; Congressman-elect Richard Pan of California, a pediatrician and former state senator with a strong record of advancing evidence-based vaccination policy; Senator-elect Abdul El-Sayed of Michigan, a physician with a doctorate in public health and a former assistant professor of epidemiology; and Senator-elect Annie Andrews of South Carolina, a pediatrician. At the state level, Amy Acton, who led Ohio’s COVID-19 response as director of the Ohio Department of Health, was elected governor. Also elected to Congress was longtime HIV prevention advocate Scott Wiener, who won the seat long held by retiring former House Speaker Nancy Pelosi. Congressman-elect Wiener was among the first prominent US elected officials to publicly disclose taking PrEP.

IMPLICATIONS: While science and HIV prevention may not have appeared explicitly on the ballot, the decisions this new Congress makes about research funding, public health and global health partnerships will have far-reaching consequences. With sizable Democratic majorities in both chambers and new public health leaders emerging in Congress and state governments, this week’s election could bring greater scientific expertise and support for evidence-based policymaking to debates over research funding, public health and HIV prevention. New congressional leadership and turnover on key committees, including those overseeing appropriations, foreign affairs, healthcare, scientific research and other relevant areas, create opportunities for stronger oversight, renewed investment in research and engagement with lawmakers on US global health leadership. The elections come amid mounting evidence of damage to the US research enterprise under the Trump administration. A New York Times investigation this week documents how federal workforce reductions, canceled and delayed grants, pressure on universities and political interference have disrupted scientific research. The National Institutes of Health (NIH) delayed or canceled more than 2,000 biomedical research grants, while the National Science Foundation withheld more than $1 billion in funding. Although Congress has rejected some of the administration’s largest proposed cuts, the incoming Congress has an important opportunity to protect sustained public investment and strengthen accountability. As AVAC’s Mitchell Warren shared, “Congress did not create the ‘Institute of National Health’ to advance national priorities. It created the ‘National Institutes of Health’ to center the leadership of United States science in global research, development, and science.” 

READ:  

• Five Global Health Questions for a Brand New Congress—With & For Substack 
• A post-midterms USAID comeback?—Devex 
• What do the US midterm results mean for global development?—Devex  
• Health policy effects of budgetary actions under the second Trump administration—Lancet Regional Health 
• How Trump is Dismantling America’s Scientific Research Machine—New York Times  
• Five midterm winners and losers: MAHA mowed down, Dem docs scrub in, ‘Medicare for All’ returns—STAT  
• Top health takeaways from the midterm elections—STAT  
• Democrats win power to push back on Trump’s health care moves—STAT 
• New Congress Must Fight to Save Public Health—Defend Public Health 
• Democratic doctors and scientists ride the blue wave—STAT 
• A ‘STEM wave’: Democratic doctors, scientists win a record number of seats in the midterms—Washington Post 
• Meet the Doctors and Scientists Who Won in the Midterms—TIME  
• U.S. midterm election results brighten prospects for science—Science

US FDA Approves First Generic of Lenacapavir for HIV PrEP (LEN)

The US Food and Drug Administration (FDA) granted tentative approval to Dr. Reddy’s Laboratories for the first generic version of twice-yearly injectable lenacapavir (LEN) for PrEP. This comes just over two years since the first efficacy results from the PURPOSE trials, marking a significantly accelerated timeline to access. This timeline reflects early licensing by Gilead Sciences, technology transfer to generic manufacturers initiated before regulatory approval, and investments by Unitaid and the Gates Foundation to accelerate development by Dr. Reddy’s and Hetero. The approval enables procurement of generic LEN by PEPFAR and the Global Fund, with initial supplies expected to reach countries before the end of 2026. However, the approval covers only the injectable formulation, not the oral tablet loading dose needed to initiate PrEP. Generic oral approvals are anticipated in early 2027, making next year a transition period during which programs may rely on a combination of originator and generic products. 

IMPLICATIONS: The generic approval is a step toward lower prices and greater volumes of LEN, which will help with access, but regulatory approval alone will not translate into public health impact. AVAC and Access Bridge recently released Now What with Injectable LEN for PrEP, which calls for faster, more ambitious scale-up than the current Global Fund and PEPFAR commitment with the call to reach at least three million people by the end of 2027, which is “a floor, not a ceiling.” Earlier generic availability creates an opportunity to increase procurement volumes, drive down prices and expand access, but success will depend on country readiness, sustained financing, demand generation and effective delivery. Licensing and manufacturing are critical milestones, but the ultimate measure of success will be how quickly LEN reaches the people who want and need this new prevention option.

READ: 

• U.S. FDA approves first generic injectable lenacapavir for HIV prevention—Unitaid  
• FDA Approves Generic Lenacapavir PrEP — But Not for the U.S.—POZ  
• Lenacapavir, PrEP demand, and the efficacy-effectiveness gap in South African HIV prevention—South African Medical Journal 
• FDA OKs generic HIV prevention shot, widening access for lower-income countries—STAT  
• FDA tentatively approves first generic lenacapavir for HIV prevention in lower-income countries—Managed Healthcare Executive  
• FDA Approves First Generic of HIV Prevention Drug, Lenacapavir—Health Policy Watch  
• U.S. approval of cheap, generic HIV prevention shot may boost global rollout—Science  

The Global Fund’s Next Chapter

Last week we covered Mark Dybul’s appointment as executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which comes amid major changes to global health financing, including an 18% decrease in Global Fund financing compared to the previous three-year cycle. In new interviews with Health Policy Watch and Science, Dybul outlined his vision for the Global Fund. He describes the current moment as a “huge opportunity” to rethink global health financing and strengthen country ownership and emphasizes aligning external investments with national health plans, reducing duplicative management and reporting systems, and supporting countries to transition toward greater domestic financing. He also acknowledges the risks of reduced funding for community-led services and key populations, stressing that country ownership must include communities and civil society, not just governments. 

IMPLICATIONS: In a new analysis for ONE Data, former Global Fund Board member Jirair Ratevosian outlines ten critical questions facing the incoming leadership, including whether the Fund should expand beyond its HIV, TB and malaria mandate, how to sustain services as countries transition from donor support, and whether its procurement platform could play a larger role in accelerating access to innovations like LEN. The analysis also recalls the decline in PrEP coverage in Global Fund-supported countries from 1.4 million people in 2024 to 1.1 million in 2025. For HIV prevention, the central question is whether reforms and greater country ownership will translate into sustained financing, meaningful community leadership and faster access to prevention innovations—or leave critical services and marginalized populations further behind. 

READ: 

• Dismissing Geneva Mergers, Global Fund’s Dybul Wants to Focus on Country Capacity—Health Policy Watch  
• Ten Questions Shaping the Global Fund’s Future—ONE Data  
• Former head of global health fund returns, eyeing a ‘huge opportunity’ despite political and financial challenges—Science  

What We’re Reading

• Sheryl Gay Stolberg, NYT: Contagion of Mistrust—CSIS  
• Biscuit Tins, Barricades and Boardrooms: Linda-Gail Bekker, The Scientist Who Fought HIV Denialism—VICE  
• Case Update: Court Rejects Government’s Bid to Dismiss Dr. Jeanne Marrazzo’s Retaliatory Firing—Katz Banks Kumin 
• AFGHS co-signatory countries ask health care users to help fill the financing gap—To End A Plague…Again Substack  
• The tough realities facing Trump’s global health deals—Devex  
• Five overlooked steps to identify new epidemics, fast—Nature 
• Open letter to G20 leaders: Failing to act swiftly on Ebola outbreak in Africa risks a global crisis—The Elders 
• ‘No one is safe’ as Ebola outbreak surges to more than 10,000 cases, Africa’s top doctor warns Canada—CBC  
• What to Expect of Ebola Emergency Responses Amid Regional Spread—Think Global Health  
• Two new candidate vaccines to join Ebola trial as treatment research advances—WHO  
• New York child dies from measles in state’s first fatal case in 30 years—The Guardian 
• Doctors Say a Rare Kind of Measles Is on the Rise—The Atlantic 
• CDC scientists sought urgent alert on measles in pregnancy. It wasn’t approved.—Washington Post 
• U.S. expands access to unapproved peptides—Science 
• The Trump-Kennedy Effect on US Health: Slow-Burn Damage Over Decades—Health Policy Watch 
• Gilead rakes in huge profits while millions go without HIV prevention medicine—MSF 
• New research center aims to accelerate hepatitis C vaccine development—News Medical  
• First ever trial of long-acting injection against malaria to launch in Africa—The Telegraph 
• Delivery of US humanitarian aid undergoes historic shift—Devex 
• Is Germany ready to take the lead on global health?—Devex  
• Vasee Moorthy—Lancet Infectious Diseases  
• Postcards from IDWeek: Growing number of infectious disease professionals embrace advocacy—CIDRAP 

Resources

• Health Care in the 2026 Midterm Election—KFF
• Hiding in Plain Sight: Mpox and the Cost of Neglecting Known Threats—The Independent Panel for Pandemic Preparedness and Response 
• TAG’s 2026 Pipeline Report: HIV Vaccines and Passive Immunization—TAG  
• Innovation Interrupted—Global Health Technologies Coalition