US leaders prioritize research and innovation
President Obama and FDA highlight global health tools
Major gains were made this week in the United States’ effort to harness the lifesaving potential of science, technology, and innovation to tackle global health issues and achieve major development goals in two distinct settings. Earlier this week, President Obama and other leaders highlighted the crucial role of research and innovation for new global health tools during speeches at the United Nations General Assembly and the Millennium Development Goals (MDG) Summit. Additionally, the US Food and Drug Administration (FDA) this week hosted a public hearing to explore the potential expansion of the agency’s role in advancing the development of global health products.
Building regulatory capacity, strengthening partnerships
On September 23, the FDA hosted a pivotal public hearing to examine its role in regulating and reviewing crucial global health technologies, such as vaccines, drugs, microbicides, diagnostics, and other tools that save lives worldwide. The hearing was hosted by the agency's newly mandated review group for neglected diseases of the developing world in preparation for a report the group will deliver to Congress next year on the topic.
The Global Health Technologies Coalition (GHTC) and representatives from other leading global health organizations testified at the hearing. Speakers offered several recommendations for an expansion of the FDA’s effort to advance global health products.
- Speakers proposed that the FDA strengthen its engagement with groups and entities, such as product development partnerships (PDPs), developing the tools to prevent, diagnose, and treat diseases of the developing world. Several speakers noted that it is crucial for the FDA to engage with non-traditional product sponsors, including PDPs, at several stages of product development so that the agency can serve as a mentor to these groups on regulatory issues.
- Speakers urged the FDA to help build regulatory capacity in developing nations through increased collaboration with countries and regional regulatory networks. Many countries in the developing world do not have the capacity or resources to regulate health tools and ensure that only safe and effective products are distributed to people in need.
- Speakers encouraged the FDA to bolster its partnership with global regulatory stakeholders, such as the World Health Organization (WHO). Stronger association between the FDA and partners such as the WHO can help streamline the review of new global health tools and reduce the time it takes for lifesaving medical products to reach people in need.
- Finally, speakers highlighted how incentive mechanisms, particularly the FDA's Priority Review Voucher (PRV) program, can help spur the development of new tools for diseases of the developing world.
The hearing was "extremely helpful" to the FDA's neglected disease review group, Leonard Sacks—acting director of the agency's Office of Critical Path Programs—said. He added that the hearing was only the "beginning of a process" and that there is "a lot of work ahead” for the FDA and its partners to help ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year.
President Obama at the United Nations Summit
Also this week, President Obama and other US leaders at the United Nations Summit on the MDGs highlighted the importance of innovation and research in reaching global development targets. During a speech that outlined the President’s new strategy for development, President Obama said that the country is "expanding scientific collaboration with other countries and investing in game-changing science and technology to help spark historic leaps in development."
Rajiv Shah, administrator of the US Agency for International Development (USAID), also stressed the importance of research and science to international development at the United Nations Summit. In a blog post following a USAID technology conference, Shah wrote that several of the “biggest challenges require solutions that cross borders, sectors, and disciplines. It will take all of our insights and creativity to address them in collaboration with partners around the globe.” He added, “USAID and our partners are intensely focused on harnessing science and technology to tackle the toughest development challenges. We’ll double, even triple, our efforts to integrate the agency’s use of science and technology for development."
Following the President’s speech, the White House released new fact sheets on the new development strategy and the Global Health Initiative (GHI). According to the fact sheets, the GHI will expand "investments in game-changing innovation by promoting research and development, both in terms of applied science as well as operation and implementation research, to address important questions that are immediately relevant to both GHI and partner country goals and objectives." In addition, the fact sheet on international development stresses that the United States will "invest in game-changing innovations with the potential to solve long-standing development challenges."
- GHTC powerpoint testimony at FDA hearing (851 KB PDF)
- GHTC written testimony at FDA hearing (113 KB PDF)
- Peter Hotez (ASTMH) powerpoint testimony at FDA hearing (18.2 MB PDF)
- Andrew Robertson (BVGH) written testimony at FDA hearing (134 KB PDF)
- Andrew Robertson (BVGH) powerpoint presentation at FDA hearing (611 KB PDF)
- Shin Chang (DNDi) written testimony at FDA hearing (427.87 KB PDF)
- Shin Chang (DNDi) powerpoint presentation at FDA hearing (245 KB PDF)
- GHTC fact sheet on the FDA and global health (200.69 KB PDF)
- President Obama's remarks at the MDG summit
- White House fact sheet on the US development strategy
- White house fact sheet on the GHI (95.02 KB PDF)