Research Roundup: Low-cost genome sequencing project, Novel method of treating mosquitoes for malaria, New malaria rapid test

The recent staffing cuts at the U.S. Food and Drug Administration (FDA), which affected roughly 20 percent of its workforce, have prompted concerns about the agency’s ability to fulfill its mission. The cuts would severely impact US companies and US global leadership in the biomedical space.  The global implications would be even more grievous—particularly for low- and middle-income countries (LMICs) that depend on the FDA’s regulatory leadership. Many LMICs and other countries rely on the FDA’s assessments, approvals, and post-market surveillance data to inform their own regulatory decisions. These programs, often referred to as “reliance programs,” streamline national approval processes by referencing trusted decisions from agencies like the FDA. As the agency grapples with significant staffing reductions, there could be ripple effects on these international structures.What are reliance programs?Reliance programs allow regulatory authorities in one country to draw on the evaluations, inspections, and approvals of trusted agencies—known as Stringent Regulatory Authorities (SRAs)—such as the FDA. Many LMICs use FDA decisions to streamline access to essential medicines and vaccines, avoiding duplicative reviews and accelerating timelines. This model is especially valuable where regulatory resources are limited, allowing local agencies to focus on post-market surveillance and health care delivery. The FDA’s assessments serve as a de facto quality mark, reinforcing confidence in products worldwide.One example is the World Health Organization’s (WHO’s) Collaborative Registration Procedure (CRP), which enables countries to fast-track the registration of WHO-prequalified medicines by leveraging FDA and other SRA reviews. Between 2015 and 2021, the CRP facilitated 59 approvals for 16 medicines across 23 countries, demonstrating its impact on timely access to quality-assured medicines for patients.Implications for the United StatesIf the FDA’s reduced capacity compromises its ability to effectively conduct timely reviews, update guidance documents, or perform inspections, the most immediate impacts will be felt in the United States. The United States could lose influence in setting international safety, efficacy, and quality standards if other regulatory authorities begin supplanting the FDA's role in global reliance networks. Over time, this erosion of regulatory leadership could diminish the FDA’s status as the gold standard globally—a position that has long bolstered American soft power in global health and trade. Manufacturers based in the United States that are developing products for diseases endemic in LMICs may also find their innovations at a disadvantage if the FDA lags behind other regulators in review speed or capacity or if the WHO prequalification program, which allows US manufacturers to leverage mechanisms that streamline and accelerate the deployment of their innovations in LMICs,  no longer recognizes the validity of FDA review. In 2024, for example, WHO prequalified a Hepatitis C self-test manufactured by Bethlehem, Pennsylvania-based OraSure Technologies. An innovative mpox point-of-care molecular test developed by Sunnyvale, California-based Cepheid became the first such diagnostic ever approved by WHO for emergency use. These FDA-WHO collaborations are vital for the purchase and procurement of American products. If the FDA retreats from this space, it could reduce the competitiveness of American firms in emerging markets and make the United States a less attractive regulatory partner for international collaboration. Preserving the FDA’s global standing is, therefore, not only a matter of public health but also of economic and geopolitical significance.Potential impacts on LMICsHowever, the secondary consequences could be more acute for countries relying on the FDA’s efficiency to inform their regulatory decisions. Delays in product approvals may extend the time before essential medicines reach patients in LMICs—where the burden of disease is often highest and timely access is critical. The loss of experienced personnel and institutional knowledge may also weaken confidence in the consistency and rigor of FDA assessments, prompting some regulators to reevaluate the extent of their reliance. The FDA should build its internal capacity to address neglected diseases rather than reduce staff, providing training opportunities and ensuring their workforce has the prerequisite expertise.Looking aheadTo help safeguard both domestic and global health outcomes, it will be important for the FDA to maintain its capacity to carry out timely, science-based evaluations. One upcoming opportunity to support this effort is the Prescription Drug User Fee Act (PDUFA) reauthorization, which allows the FDA to collect fees from pharmaceutical companies to help fund its drug review programs. PDUFA has long been a bipartisan priority and is key in supporting the agency’s scientific workforce and review capabilities. Ensuring the continuity of this program will help the FDA meet its responsibilities at home and abroad. As global reliance on the FDA remains high—particularly among countries with limited regulatory resources—continued investment in the agency’s capacity will be necessary both for US innovation and global health systems that depend on its leadership.Now more than ever, we must protect the FDA’s ability to lead. A weakened FDA puts American innovation and jobs at risk, slows access to breakthrough products, and opens the door for other countries to set the standards we once defined. The world looks to the FDA, not just for safety and science, but for leadership. With PDUFA reauthorization on the horizon, Congress has a critical opportunity to invest in the FDA’s workforce and secure the United States’ role as the global leader in health and biomedical innovation.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study looking at data from two separate Phase 1 clinical trials shows that a targeted vaccine strategy can successfully activate early immune responses relevant to HIV, a significant advance in longtime efforts to develop an HIV vaccine. A persistent challenge in advancing HIV vaccines has been finding a way to train the immune system to produce antibodies that target many variants of the tricky, rapidly mutating virus. The study, conducted by an international team of scientists from IAVI and Scripps Research, included nearly 80 participants from North America and Africa, helping ensure a future vaccine has global potential. One of the trials used a stepwise vaccination strategy, administering two doses sequentially to guide the immune system to develop antibodies, while the second trial found that an initial dose could successfully activate the desired immune cells. Both vaccines used an mRNA vaccine platform, enabling faster production and clinical testing.A recently published study found that a new water-soluble formulation of the only drug available to treat helminths, or parasitic worms, can achieve the same effect as the currently available tablet form at half the usual dose. Praziquantel is currently available as large tablets that are bitter and difficult to swallow, especially for children and pets. The new formulation can be dissolved in water and was shown to be more efficiently absorbed, enabling patients to receive a smaller dose without sacrificing efficacy. Further clinical testing is needed before the new formulation can be brought to market, but if it continues to demonstrate success, the new formulation could be a game-changer in addressing helminths, which affect 400 million people worldwide.