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The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health. While the FDA is best known for its work to protect the health of US consumers, the agency has a strong history of sharing its expertise to benefit people worldwide and is playing an increasingly vital role in global health issues. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Our new fact sheet and policy brief focus on five key areas at the FDA. First, the FDA leads numerous international programs from its headquarters in the United States and operates offices and posts in ten countries across the globe. As the agency expands and deepens its contributions to global health, it is essential to ensure FDA’s activities contribute to an agency-wide strategy. Therefore, the FDA should create an office of neglected diseases so that it can better drive coordination among its centers and offices to maximize its global—and domestic—health impacts. This new program should be housed within the FDA’s Office of the Commissioner. By formalizing the agency’s global health activities, better oversight can help ensure that related programs and initiatives contribute to a unified goal. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH Second, the FDA should continue to build partnerships with global regulatory stakeholders, such as the World Health Organization and national regulatory authorities. Regulatory review of products designed for use in the developing world can be particularly challenging, especially when the national regulatory authorities do not have the capacity or resources to manage the reviews. To address this issue, the FDA offers trainings and contributes to global efforts to improve regulatory harmonization. The agency also supports a variety of global regulatory initiatives. But this is just the beginning. To realize the positive impacts of these investments, FDA should continue to contribute to and expand these efforts. Third, while FDA has taken impressive steps to increase its engagement globally, without formalized reporting and oversight mechanisms the outcomes of this work can wane in the face of other priorities and funding constraints. To increase transparency and accountability for its global health commitments, the FDA should take steps to establish formalized processes to report to Congress on its neglected disease activities. Fourth, while its first priority is the health of Americans, it is essential that the FDA arms itself with global health experts who can help carry out a comprehensive plan. To strengthen the work already being conducted in the agency’s international offices and posts, FDA should dedicate additional staff members and resources to global health engagement. Finally, FDA—like so many agencies across the US government—is facing severe financial constrains due to sequestration and broader budget cuts. We’re facing the possibility of a government shutdown at the end of this month, as congressional policymakers still have not reached an agreement on the federal budget. Without question, this financial uncertainty hinders FDA’s ability to strengthen its role in global health and safeguard the health of American citizens. It’s critical that congressional policymakers pass a smart budget agreement that avoids another round of sequestration cuts while protecting key programs at FDA and other federal agencies that work in global health. As House and Senate leaders continue their budget negotiations, they have the opportunity to demonstrate their commitment to lifesaving and efficient programs at leading agencies like the FDA.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Rep. Leonard Lance (R-NJ) this week reintroduced a bill—called the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act—that aims to stimulate the development of diagnostics and potential therapies that have no patent protection. The World Health Organization has announced it will start charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components. Some public health advocates are expressing concern that fees might have a negative effect for procurement and access to medicines. Nature News examines the effects of sequestration and budget cuts on US researchers who receive funding from the National Institutes of Health (NIH). In related news, a new opinion piece in Nature argues that the effects of federal budget cuts provide an opportunity to revisit the NIH’s funding structure. The Centers for Disease Control and Prevention is supporting efforts to develop an all-natural insecticide to prevent malaria and other insect-borne diseases. The Pharmaceutical Research and Manufacturers of America released a report this week showing that 271 vaccines are under development, all in clinical trials or under review by the US Food and Drug Administration. This includes 137 vaccines for infectious diseases.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper she developed for the GHTC that outlines key funding challenges and opportunities for global health research and development (R&D). The funding landscape for global health R&D is evolving. Significant investments from governments and philanthropic organizations before the financial crisis helped create robust and promising product portfolios for poverty-related and neglected diseases and conditions. However, in the current financial climate, budget constraints are threatening this progress. Today, the GHTC is releasing a new paper that examines the implications of this changing environment—in particular, the financing challenges and opportunities facing organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for low- and middle-income countries (LMICs). Traditionally, the majority of funding supporting nonprofit product development organizations (NPPDs) to develop technologies for LMICs has been grants from government development agencies—predominately in the United States and Europe—and philanthropies. However, the funding landscape for NPPDs has changed significantly in recent years, and many organizations are reconsidering their business models and funding structures. In particular, traditional governmental and philanthropic donors have scaled back their overall investments in NPPDs, and some donors have become more restrictive in how their money is spent. A new paper from the GHTC outlines key funding challenges and opportunities for global health research and development . Credit: PATH. As a result, NPPDs are pursuing innovative financing models to sustain progress in developing new products and to attract new investment, both to fill the funding gap and to increase the flexibility of their funding. Across the diverse group of NPPDs we surveyed for the paper, we found common funding challenges that each is grappling with in this new environment. Donor shifts away from core funding to more narrowly restricted funding. Donors are increasingly awarding project-specific funding, which can only be used for a designated activity, as opposed to core funding that gives NPPDs the ability to support multiple projects at different stages of development. Because of this shift, NPPDs noted that funding can significantly influence scientific decision making. Each of the NPPDs interviewed said that this shift away from more flexible core funding toward project-specific funding is their most significant challenge. The small number of major funders. Shrinking resources means that NPPDs cannot keep pace with the increased costs of progressing new health products through large-scale studies. As a result, funding available to NPPDs is shrinking just as promising products are advancing through the research pipeline into large-scale studies needed to demonstrate safety and efficacy in diverse populations. Discordant funder priorities and requirements. As some funders scale back on their support, NPPDs are increasingly seeking out multiple donors and funding sources. While funding diversification can help provide independence, it can result in the misalignment of funder requirements. NPPDs with varied funding sources can experience challenges in managing multiple funder requirements, which creates the need for more administration and staff resources. Limited capacity to identify, cultivate, and sustain funding. As NPPDs seek out new funding opportunities, they must invest in a new configuration of skills—including managing, identifying, and cultivating new sources of support. This involves dedicating additional staff time, sometimes from researchers, and establishing new systems to cultivate new donor relationships. NPPDs noted that while the funding environment presents many challenges, there are also new investment and partnership opportunities. To ensure that the goal of creating cost-effective, culturally relevant, affordable, and accessible products is driving their work, NPPD outlined criteria that can be used to design and evaluate financing. Specifically, funding mechanisms and donor support should: Support a portfolio of products at different stages of development. This ensures that only the most promising products advance through the research pipeline and allows NPPDs to shift funds to more promising projects. It also ensures that the entire product development lifecycle—from preclinical through introduction and wide-scale adoption—is funded. Provide sustainable funding commitments. Additionally, the duration of funding commitments should be guided by the scientific need. This will require multi-year funding commitments that align with the timelines of the product development process. Support core activities. These activities—such as administrative and facility costs, support activities for advocacy and public awareness, and the cultivation of new funding sources—are critical to the success of any organization. All funding should include a proportionate level of support for the overall costs of running the organization or specific program. Incentivize new investment. Funding is most effective when it can be used to attract new financial support and other investments. The more flexible the funding, the better able the recipient is to create opportunities to complement existing investment. All of the NPPDs noted that exploring new financing models is not new to them but that they must continue to adapt their financing models and explore new opportunities to respond to an evolving funding environment. Finally, better collaboration among stakeholders—including NPPDs, governments, academia, foundations, and the private sector—is critical to maximizing R&D funding to improve health and well-being in LMICs.

The Global Health Technologies Coalition (GHTC) today released a new paper that provides unique insight into the funding landscape for global health research and development (R&D). The paper examines key financing challenges and opportunities facing organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for low- and middle-income countries (LMICs). The paper focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeted for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, maternal health, and other needs in LMICs. Previous research has found that NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The new GHTC paper finds that the funding landscape for NPPDs has shifted in recent years, with donors from the public and private sectors reducing their overall investments in product development for LMICs. For instance, funding for NPPDs has seen a decrease of $50 million per year since 2009. The paper identifies four main funding challenges facing NPPDs in this changing funding environment: The small number of major funders means that NPPDs cannot keep pace with the increased costs of progressing new health products through large-scale studies. As a result, funding available to NPPDs is shrinking just as promising products are advancing through the research pipeline. Donors are increasingly awarding project-specific funding, which can only be used for a designated activity, as opposed to core funding that gives NPPDs the ability to support multiple projects at different stages of development. Because of this shift, NPPDs noted that funding can significantly influence scientific decision making. As some funders scale back on their support, NPPDs are increasingly seeking out multiple donors and funding sources. While funding diversification can help provide independence, it can result in discordant funder priorities and requirements. NPPDs with varied funding sources can experience challenges in managing multiple funder requirements and gaps in funding. As NPPDs seek out new funding opportunities, they must invest in developing new skill sets—including managing, identifying, and cultivating new sources of support. This involves dedicating additional staff time, sometimes from researchers, and establishing new systems to cultivate new donor relationships. Fortunately, the paper also finds that NPPDs are adapting in this new funding environment. For instance, many NPPDs are developing approaches to address these financing challenges, such as forming new partnerships and exploring innovative financing to sustain progress. The paper also provides a set of criteria that donors, NPPDs, and others can use to evaluate and better coordinate global health R&D funding opportunities. According to the paper, funding mechanisms and donor support must: Support a portfolio of products at different stages of development. This ensures that only the most promising products advance through the research pipeline and allows NPPDs to shift funds to more promising projects. Provide sustainable funding commitments. Additionally, the duration of funding commitments should be guided by the scientific need. This will require multi-year funding commitments that align with the timelines of the product development process. Support core activities. These activities are critical to the success of any organization. All funding should include a proportionate level of support for the overall costs of running the organization or specific program. Incentivize new investment. Funding is most effective when it can be used to attract new financial support and other investments. This paper—Financing and Coordination of Health Research: Perspectives from Nonprofits on Accelerating Product Development and Improving Access for Low- and Middle-Income Countries, Volume 2—is the second in a series from the GHTC that examines financing, accessibility, regulatory, and capacity issues facing NPPDs. The series aims to inform global policy and financing discussions about R&D for neglected and poverty-related diseases affecting LMICs.