Breakthroughs Blog: FDA

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Food and Drug Administration has announced it will give priority review to a new treatment for multi-drug resistant tuberculosis. The announcement came after the drugmaker applied to the European Medicines Agency for approval. Nils Daulaire, director of the Office of Global Affairs at the US Department of Health and Human Services, writes about the agency’s first-ever global health strategy. Reuters recently examined several scientific breakthroughs in HIV and AIDS in recent years, and how the global financial crisis could impact progress against the disease. An article looks at how the US presidential candidates would handle foreign aid and international development if elected in November. A related piece examines the social, political, and financial issues at play ahead of the presidential election and their implications for domestic and global health programs.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. A new bill introduced in the House of Representatives aims to tighten reporting requirements for ClinicalTrials.gov, the public online registry run by the National Institutes of Health. The HIV and AIDS drug Truvada safely and effectively reduces the risk of HIV for certain at-risk populations, according to the first US Centers for Disease Control and Prevention guidelines on using the drugs for prevention. Nature Medicine recently examined how several pharmaceutical companies are testing new drug candidates to treat drug-resistant tuberculosis. The Government Accountability Office has released a new report that details regulatory policies and requirements put into place under various US global health programs. The Bill & Melinda Gates Foundation announced that Dr. Orin Levine has been named director of Vaccine Delivery. Levine, a member of the GHTC, is currently a professor of International Health and executive director of the International Vaccine Access Center at the Johns Hopkins University’s Bloomberg School of Public Health.

In this feature on Breakthroughs, we provide an update on what’s currently happening with global health in Congress and an outlook for future legislative activity. Following the August recess and Labor Day Holiday, Congress is now back for a very brief time before it takes another break to focus intensely on campaigning ahead of the November elections. We don’t expect much action on legislation specific to global health or research programs. Instead, Congress will focus on passing a Continuing Resolution (CR) for fiscal year 2013 in order to keep the government running through the end of March 2013, as members juggle the remaining legislative tasks on their plate. The CR actually includes a tiny 0.6 percent increase across the board for all federal programs, including those that fund global health research. However, the resolution will expire long after the looming budget sequestration goes into effect in January 2013 and will also run into the fiscal year 2014 budget process, effectively creating a budgeting perfect storm. Advocates for a wide range of federal programs are in high gear to convince Congress to delay sequestration or to pass a balanced budget in its place. Some of those advocates have found congressional allies willing to take on their cause. Also this week, we’re looking for a report from the Obama Administration on the potential impact of sequestration on federal agencies. As we outlined in our last update, sequestration could result in cuts ranging from 8.5 percent to 14 percent to most federal programs, depending on the outcome of the budget negotiations in Congress and the November elections. Sequestration would undoubtedly have a significant impact on global health and research programs at agencies like the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, the National Institutes of Health, and the US Agency for International Development. We’re eager to see this report and learn more about how sequestration might impact efforts supported by these agencies to develop new lifesaving global health tools. Global health research and development (R&D) programs span the breadth of the US budget. Congress needs to work to protect these essential R&D programs from disproportionate cuts and ensure that funding is sustained—and increased if possible—for the coming years. Although the elections may be on the top of everyone’s to-do list for now, temporary budget fixes that leave these activities vulnerable to indiscriminate cuts and similar actions will not work forever. We need a plan that protects global health R&D and other key programs for the long-term, and right now, that job starts with Congress.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Food and Drug Administration has approved the use of a new diagnostic test developed by the Centers for Disease Control and Prevention for earlier detection of dengue fever in the United States. Research!America has launched a new ad campaign that promotes US federal investments in driving research for new global health tools. A recent article in the Journal of Medical Microbiology discusses some of the scientific, financial, and ethical challenges in vaccine development. A new report by BIO Ventures for Global Health and the Biotechnology Industry Organization found that small- and medium-sized biotechnology companies are tackling the development of treatments, diagnostics, and other tools for neglected diseases. Congressman Edward Markey (D-Mass.) calls for a “detailed understanding of the harm” that mandatory cuts in the US federal budget to agencies such as the National Institutes of Health “pose to vital health programs upon which millions of Americans around the nation rely.”