Breakthroughs Blog: FDA

With the results of the presidential and congressional elections now almost two days behind us, there has been increasing reaction and speculation about what President Barack Obama’s second term and new congressional leadership could mean for foreign policy, international development, and global health. Below, we provide a round-up of some of the most interesting reads in the wake of the election results. Devex examines if Obama’s re-election is a “boon for US foreign aid.” While “Obama’s win is good news for the US Agency for International Development (USAID), which could have faced deep budget cuts in a Republican administration,” questions still “linger” over leadership. “Secretary of State Hillary Clinton is not expected to stay for more than a few months into Obama’s second term, if at all. Some Washington insiders also suggest that USAID Administrator Rajiv Shah is interested in pursuing a political career sooner rather than later.” According to the US Global Leadership Coalition (USGLC), the election has resulted in “broad bipartisan support for America’s global leadership and the International Affairs Budget,” although there are “challenges ahead to reconcile commitments to development and diplomacy with the need to address America’s fiscal crisis.” USGLC provides a detailed look at the new players in Washington and the likely playing field for the 113th Congress. The Center for Global Development identifies the “five things that should be at the top of the President’s global health agenda for the next four years.” These priorities include the President’s Emergency Plan for AIDS Relief, strengthening global health partnerships, and sustainability. Both National Journal and Foreign Policy examine how Rep. Howard Berman’s (D-CA) loss and a new Republican chair of the House Foreign Affairs Committee will shake up the foreign policy leadership in Congress. National Journal reports that one day “after the election ensured Republicans will keep their majority in the next Congress, Rep. Ed Royce (R-CA) made his first public play to secure the chairmanship of the House Foreign Affairs Committee.” And according to Foreign Policy, “Berman will be remembered for his decades of tireless work on foreign policy and his reputation as a legislator who sought to build consensus to push forward a bipartisan agenda.” Pharmalot looks at what the US Food and Drug Administration (FDA) will look like after the election results have settled. “Apart from an occasional reference, the agency is not part of the campaign dialogue.” However, the FDA will still be affected by the looming sequester, which would leave the agenda with about $320 million less to spend in Fiscal Year (FY) 2013 than it did in FY 2012. Pharmalot also examines what could happen to FDA leadership in the coming months.

Since our last update on the latest budget action on the Hill, two significant events happened late last week in Congress and at the White House. First, the White House’s Office of Management and Budget (OMB) released a report on the potential impact of sequestration on federal agencies. Sequestration would require a reduction in government spending of $109 billion per year for nine years, beginning in January 2013. According to the report, most defense programs relevant to global health—including global health research and development (R&D) programs at the Department of Defense—would receive a 9.4 percent cut under sequestration. Non-defense programs—including most programs at the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), the State Department, and the US Agency for International Development (USAID)—that are not exempt from cuts would receive an 8.2 percent cut. It’s important to note that some parts of these programs’ funds are exempt from cuts. For instance, out of a total budget of $34.249 billion for the NIH in fiscal year (FY) 2013, the sequestration applies to $30.861 billion. The rest is exempt. As for the primary agencies that fund global health and R&D programming, the report finds that: The total cut to NIH would equal $2.529 billion. This would put NIH’s total funding for FY 2013 at $31.720 billion. At USAID, the Global Health Programs account—the account responsible for all of USAID’s global health R&D work—would be cut by $670 million, leaving the final global health program’s funding level at $7.498 billion. The FDA, which plays a key role in regulating global health products, would see a cut of $318 million, with a final funding level of $3.624 billion (not including funding from user fees). The CDC would see a cut of $470 million from its overall funding, with $464 million coming from non-defense activities funding. This leaves CDC with a final funding level of $6.861 billion. These predictions are based on current FY 2012 funding levels. Many of these agency programs are already dealing with looming cuts to their funding levels for next year under various congressional budget proposals. If FY 2013 appropriations bills in Congress reduce agencies’ funding even further, the sequestration cuts would be even steeper than what’s outlined in the OMB report. Second, the House of Representatives late last week approved a Continuing Resolution (CR) for FY 2013, in order to keep the government running through the end of March 2013. The House approved the measure by a vote of 329-91, with 70 Republicans and 21 Democrats in opposition. The bill now moves to the Senate and is expected to pass this week. The CR funds the government at $1.047 trillion, consistent with the Budget Control Act. It also includes a slight 0.6 percent increase across the board for all federal programs, essentially maintaining spending at current levels. The CR provides a total of $55.2 billion for International Affairs, slightly higher than the $54.9 billion current level and higher than either the House or Senate FY 2013 appropriations recommendations. House Appropriations Committee Chair Hal Rogers (R-KY) said that lawmakers will aim to finalize appropriations bills when they return to work after the November elections. “We intend to use the lame-duck session to the fullest extent,” he said, adding, “Just because this CR will last until March 27 of next year, we will not rest on our laurels until that time.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Cipla and the Drugs for Neglected Diseases initiative recently announced that their malaria drug has been prequalified by the World Health Organization, an important step toward its roll-out across Asia. A new report from the Kaiser Family Foundation provides a comprehensive look at the Department of Defense's role in global health, including the department’s research and product development efforts. The US Food and Drug Administration has awarded GHTC member Aeras a grant worth $299,525 to spur the development of new vaccines against tuberculosis. A new study finds that the way medical research is funded in the United States has been vastly altered over the last 20 years by advocates asking that research be focused on particular diseases. A widespread vaccination campaign to protect 50 million people against meningitis with a new vaccine has been launched in seven African countries, health officials said Thursday.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Christopher Austin has been named the new director of the National Center for Advancing Translational Sciences at the National Institutes of Health. A new analysis compares the innovation and science policies of presidential candidates Barack Obama (D) and Mitt Romney (R). A bill signed into law earlier this year that provided the US Food and Drug Administration (FDA) with funding is at risk due to federal budget negotiations. An opinion piece calls on US policymakers to “get serious” about funding scientific and research efforts. A breakthrough tool to combat tuberculosis has been launchedby the Critical Path Institute and the Clinical Data Interchange Standards Consortium (CDISC). The project was the result of collaboration between the Critical Path Institute, CDISC, the FDA, and others through the Critical Path to TB Drug Regimens. Researchers met this week in Boston for the AIDS Vaccine 2012 conference to discuss the latest in efforts to develop a vaccine against the disease.