Top 10 2011 policy breakthroughs in global health R&D

2011 was a year full of exciting advances in global health research and development, complicated by a volatile budget climate. While many research breakthroughs occurred this year, including preliminary clinical findings for a malaria vaccine, the first evidence that HIV treatment is effective as prevention, and promising new drug candidates for several neglected tropical diseases (NTDs), it is important to recognize the strides made in the policies that fuel this critical life-saving progress. Below is our list of the top ten global health R&D policy breakthroughs of 2011:

1) Protection of global health funding: In a year of severe budgetary issues, where nearly all discretionary US government spending for Fiscal Year 2011 (FY 2011) saw drastic cuts, most global health accounts at the US Agency for International Development (USAID) were modestly increased – a victory compared to the devastating reductions other accounts have seen. USAID needs this critical funding to support vital health technology product R&D in developing countries and helps deliver lifesaving tools around the globe.

2) NIH expands global health research activities: Congress has approved and funded the new NIH National Center for Advancing Translational Science, which will promote research aimed at speeding the development of therapeutics and diagnostic tools for a wide range of diseases, including global diseases. Additionally, NIH’s National Institute for Allergy and Infectious Diseases announced that its six current HIV and AIDS clinical trials networks (CTNs) will begin to include research for infectious diseases other than HIV and AIDS. Researchers in tuberculosis, other HIV and AIDS co-infections, and other global health advocates have called for this change since the success of the CTNs became evident. For its first phase, the focus of the expansion will be on antibacterial resistance.

3) USAID Administrator Shah highlights innovation: In February, USAID Administrator Rajiv Shah gave a groundbreaking speech at the National Institutes of Health (NIH) emphasizing the importance of science, technology and innovation in development programs, particularly global health. Shah also announced the creation of a Center of Excellence on product development and field introduction.

4) Congressman Howard Berman releases foreign aid proposal that includes global health priorities: Congressman Howard Berman (D-CA) released a discussion draft version of the Global Partnerships Act of 2011, a bill which would reform and improve the US foreign assistance act. The proposal includes several initiatives that emphasize a need to support global health research and innovation. The GHTC has worked with Congressional staff and community members to support the progress of the legislation, including holding a briefing and releasing a fact sheet on the role of global health technologies in foreign assistance.

5) FDA rolls out guidance for industry on developing products to combat neglected tropical diseases: In August, the FDA released a guidance to industry with recommendations on the development and review of drugs to treat NTDs. The guidance reflects FDA’s mandate to review and license technologies for diseases not endemic to the United States, as well as its commitment to work with private industry in moving such products through the regulatory pipeline. GHTC has submitted comments to the guidance, applauding its overall principles and recommending improvements.

6) USAID announces Saving Lives at Birth awards: In 2011, the Saving Lives at Birth program awarded 19 seed grants and 3 transition grants to global health products currently in development that could help save the lives of mothers and infants worldwide. The program is a partnership between USAID, the Bill and Melinda Gates Foundation, the Government of Norway, Grand Challenges Canada and the World Bank.

7) FDA budget increases in constrained times: In both FY 2011 and FY 2012, the FDA received small funding increases of $96 million and $50 million, respectively. In the current budget climate where most programs are seeing large cuts, it is a very positive result.

8) America COMPETES Act is implemented: Early in 2011, President Obama signed the America COMPETES Act into law, which among many other things gives US agencies the power to use prize competitions to spur research and innovation into new technologies or programs that will benefit US efforts. In August, the Office of Management and Budget released a memo to each agency head outlining how prize mechanisms could be used, and requesting feedback and reports on implementation of the new law. The prize mechanisms, as showcased by USAID’s Saving Lives at Birth program, are engaging non-traditional innovators from around the world to develop new technologies to solve global health challenges.

9) FDA restructuring increases agency’s role in international regulatory issues: FDA Commissioner Margaret Hamburg announced structural and personnel changes at the agency that will have huge implications for global health, including the creation of directories focused on global issues, and a new directorate for Global Regulatory Operations and Policy. In July 2011, FDA also announced a new “entrepreneur-in-residence” position to improve relationships with the private product development sector.

10) Creating Hope Act of 2011 is introduced in Congress: In March, Senator Robert Casey (D-PA) introduced the Creating Hope Act of 2011, which makes improvements to the Priority Review Voucher program at the Food and Drug Administration (FDA). In September, Congressman Michael McCaul (R-TX) introduced a companion version of the bill in the House. The House version now has more than 90 cosponsors. The PRV program provides a voucher to companies submitting a technology for a neglected disease for use for a later drug submission, incentivizing R&D for new global health tools. The legislation would alter the list of applicable diseases by adding Chagas disease and also adding a category of rare diseases.