Research Roundup: What we’re reading this week

This week, many GHTC members will be in New York for the sixty-eighth session of the United Nations’ General Assembly (UNGA), where, among other topics, progress toward meeting the Millennium Development Goals (MDGs) will be addressed. Especially relevant this year will be discussions around the post-2015 development agenda. As we close in on the year 2015, and thus the deadline for the MDGs, there is a great deal of speculation about what set of goals, targets, and indicators will drive our development work for the next period. We’ve seen hints through reports released by a High-Level Panel on the Post-2015 Development Agenda, and by the Secretary General himself. But much of the work remains to be done, and as of yet there is still a great deal of uncertainty about what the agenda will look like in its final form. We should know more after this week. Previous investments in research to develop new vaccines, drugs, diagnostics, and other tools have led to some of the greatest advances in global health to date. Credit: PATH. Although it was good to see achievements brought about by health science and technology noted in both reports, there is a strong need for greater recognition about the need for new medical innovations to carry us through this next period—as well as the commitments and leadership that will get us there. Previous investments in research to develop new vaccines, drugs, diagnostics, and other tools have led to some of the greatest advances in global health to date, saving countless lives and resulting in billions of dollars in cost savings. With sustained investment and support, further gains are achievable: from the eradication of polio, to the elimination of malaria; from controlling and ending the AIDS and TB epidemics, to effectively diagnosing and treating neglected tropical diseases. The post-2015 development agenda must prioritize innovation for health, and I’ll be listening and talking with development leaders this week to discuss how this can be achieved. Excitingly, innovation seems to be featured in a number of side events that will take place this week—including the MDG Innovation Forum. Through these events, global health and development partners intend to highlight the role that innovation, research and development, and public-private partnerships play in helping us to achieve our development goals. Research and development for new, innovative health tools will be essential to achieve any international development goals and enable more equitable and sustainable improvements across health services and health outcomes. I hope that global health innovation is strongly supported by leaders during this week’s UNGA and that the discussions held this week will result in concrete support for global health research and product development as a key component of the post-2015 development agenda.

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.