Research Roundup: What we’re reading this week

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. Over the past several weeks, Congress has been incredibly active on the federal budget and other pieces of legislation that could have implications for global health research and development (R&D). Below, we provide an overview of the most recent action, and what the next several weeks could bring. Yesterday, the House Foreign Affairs Committee approved the Foreign Relations Authorization Act with no amendments. The bill only authorizes the State Department’s operations—there is no policy or programmatic language included for international development or global health. During a much different hearing than last year’s controversial two-day event, both Democrats and Republicans worked to create a compromised bill that contains suggested funding levels in line with the fiscal year (FY) 2012 final budget levels dictated last year by the House Appropriations Committee. Late last week, the House Energy and Commerce Committee held a hearing on the progress and future of the National Institutes of Health (NIH). NIH Director Francis Collins testified during the hearing, saying that looming sequestration—or across-the-board cuts in the federal budget—“could do serious damage to the progress that we now see in medical research.” Collins also discussed how the NIH’s new National Center for Advancing Translational Sciences would likely take large cuts in funding under sequestration. Earlier this week, the Senate passed the FDA Safety and Innovation Act, which includes a reauthorization of both the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA). The bill will now go to President Obama, and he is expected to sign it into law. While reauthorizing PDUFA and MDUFA does provide the Food and Drug Administration with much needed funding, the bill also contains the Generating Antibiotics Incentives Now (GAIN) provision, which contains some controversial elements regarding R&D data exclusivity. Additional information is available here and here. There are two recent measures in Congress and the Administration that could impact the federal budget in the coming weeks: The House Budget Committee may soon introduce legislation (HR 5872) that could help delay the implementation of sequestration—some in the global health community estimate that sequestration could amount to cuts for global health R&D between 8 percent and 12 percent across the US Government. The proposed legislation, authored by Budget Committee Chair Paul Ryan (R-WI), would require President Obama to report within 30 days on the impact of automatic cuts to the federal government at “program, project, and activity” levels. Office of Management and Budget (OMB) Acting Director Jeffrey Zients recently sent a memo to department and agency heads with guidance on agency submissions for FY 2014 budgets. The memo asks agencies to cut lower-priority spending to allow for continued investment in "areas critical to economic growth and job creation, including education, innovation, infrastructure, and research and development." The memo also directs agencies to exclude the across-the-board sequestration from their requests. Of course, most people in Washington are talking about the Supreme Court, and today’s ruling on the Affordable Care Act. The Court’s ruling, as well as the rapidly heightening politics surrounding the Presidential campaigns, could affect progress on finalizing a FY 2013 budget and securing a deal to avoid total sequestration. With everything that Congress needs to complete before the end of the calendar year, we may know the election result before we know next year’s final funding levels for key global health R&D programs.

Last week, the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) announced a key benchmark for the program—the formation of its new Advisory Council, which will meet for the first time later this month. Since NCATS was created, the GHTC has been particularly interested in tracking its progress in taking up initiatives that could accelerate the development of new drugs for global health. As the largest funder of global health research and development in the world, the NIH must ensure that its initiatives and programs like NCATS continue to support the creation of much-needed new tools like vaccines, drugs, and diagnostics. We’ve been waiting for NCATS to announce its Advisory Council members, in the hopes that scientific experts with a background in global health would provide much-needed guidance to the center’s director—as well as NIH Director Francis Collins and Health and Human Services Secretary Kathleen Sebelius—on NCATS policies, initiatives, and programs. It comes as a disappointment, therefore, to learn that no global health experts are serving on the NCATS Advisory Council during this initial four-year term. Much like new initiatives coming out of NCATS, the center’s new council seems to focus primarily on diseases that affect US populations. NCATS should do more to speed the development of drugs for global health. There’s no question that rare and other diseases in the US deserve support from NCATS. But so do neglected diseases that affect people around the world. And as Peter Hotez from the Sabin Vaccine Institute recently pointed out, neglected tropical diseases, traditionally “confined” to developing countries, are becoming the new diseases of poverty in the US. With support from NCATS and other US government programs, researchers should receive much-needed funding to create new tools to fight neglected diseases that have long impacted people overseas and are now appearing domestically. It was encouraging to see that the new Review Board at the Cures Acceleration Network, an NCATS program, includes two global health experts. We hope that NCATS and its Advisory Council follow suit and start prioritizing research for global health.