Breakthroughs Blog: FDA

The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health. While the FDA is best known for its work to protect the health of US consumers, the agency has a strong history of sharing its expertise to benefit people worldwide and is playing an increasingly vital role in global health issues. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Our new fact sheet and policy brief focus on five key areas at the FDA. First, the FDA leads numerous international programs from its headquarters in the United States and operates offices and posts in ten countries across the globe. As the agency expands and deepens its contributions to global health, it is essential to ensure FDA’s activities contribute to an agency-wide strategy. Therefore, the FDA should create an office of neglected diseases so that it can better drive coordination among its centers and offices to maximize its global—and domestic—health impacts. This new program should be housed within the FDA’s Office of the Commissioner. By formalizing the agency’s global health activities, better oversight can help ensure that related programs and initiatives contribute to a unified goal. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH Second, the FDA should continue to build partnerships with global regulatory stakeholders, such as the World Health Organization and national regulatory authorities. Regulatory review of products designed for use in the developing world can be particularly challenging, especially when the national regulatory authorities do not have the capacity or resources to manage the reviews. To address this issue, the FDA offers trainings and contributes to global efforts to improve regulatory harmonization. The agency also supports a variety of global regulatory initiatives. But this is just the beginning. To realize the positive impacts of these investments, FDA should continue to contribute to and expand these efforts. Third, while FDA has taken impressive steps to increase its engagement globally, without formalized reporting and oversight mechanisms the outcomes of this work can wane in the face of other priorities and funding constraints. To increase transparency and accountability for its global health commitments, the FDA should take steps to establish formalized processes to report to Congress on its neglected disease activities. Fourth, while its first priority is the health of Americans, it is essential that the FDA arms itself with global health experts who can help carry out a comprehensive plan. To strengthen the work already being conducted in the agency’s international offices and posts, FDA should dedicate additional staff members and resources to global health engagement. Finally, FDA—like so many agencies across the US government—is facing severe financial constrains due to sequestration and broader budget cuts. We’re facing the possibility of a government shutdown at the end of this month, as congressional policymakers still have not reached an agreement on the federal budget. Without question, this financial uncertainty hinders FDA’s ability to strengthen its role in global health and safeguard the health of American citizens. It’s critical that congressional policymakers pass a smart budget agreement that avoids another round of sequestration cuts while protecting key programs at FDA and other federal agencies that work in global health. As House and Senate leaders continue their budget negotiations, they have the opportunity to demonstrate their commitment to lifesaving and efficient programs at leading agencies like the FDA.

  As we discussed yesterday, lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. Our first post yesterday detailed implications for global health research and development (R&D) activities at the US Department of State and US Agency for International Development. Today, we provide highlights for other key agencies involved in global health R&D. Labor-HHS The Senate Appropriations Committee has approved legislation to fund the Labor, Health, and Human Services (HHS) account, which includes support for the National Institutes of Health (NIH) and the US Centers for Disease Control and Prevention (CDC). Currently, there is no House version of this bill—a hearing scheduled for last week was canceled—so while we don’t have those figures to compare funding levels with, we do know that the House allocation for this account is drastically lower than the Senate version. Lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. including the DoD, CDC, FDA, and NIH. The Senate bill would fund the NIH at $30.9 billion, which is a welcome but small increase of $307 million over FY 2013. Many key institutes and centers—including the National Institute of Allergy and Infectious Diseases, the National Institute of Child Health and Human Development, and the Fogarty International Center—were funded at levels higher than the final FY 2013 allocations but lower than the levels President Obama requested for FY 2014. One exception is the National Center for Advancing Translational Science, which received a total of $662.4 million under the bill—a boost in funding of $87 million over FY 2013. This includes a total of $50 million for the Cures Acceleration Network. The legislation would fund CDC at $6.9 billion, an increase of $681 million over FY 2013 and $300 million over the President’s request. This funding includes $391 million for the Center for Global Health, a significant increase of $46 million over FY 2013. The National Public Health Institutes received a $10 million allocation under the bill, which also included a large bump for polio eradication: $146 million versus the $131 million the President requested and the $116 million from FY 2013. The National Center for Emerging Zoonotic and Infectious Diseases was funded at $335 million, an increase of $44 million over FY 2013. FDA The House recently passed its appropriations legislation to fund the US Food and Drug Administration (FDA), providing the agency with $2.485 billion (not including income from user fees). This is roughly $20 million more than the agency received in FY 2013 and $40 million more than the President requested. Language was included in the bill that would ensure the FDA can review products for all neglected diseases, encourage the agency to “build stronger partnerships with global regulatory stakeholders, and strengthen its internal capacity to review products for neglected diseases.” Similar language was included in the Senate version of the legislation, which funds FDA at a higher level of $2.562 billion, or roughly $77 million more than the House version. Defense The full House passed a Department of Defense funding bill, in which the entire agency was provided with $513 billion. The bill would also provide $9.6 million for malaria vaccine development efforts, and welcome language is included in the bill report regarding the need for such a vaccine. The Senate Appropriations Defense subcommittee voted on its version of Defense funding yesterday, July 30th. We’re still waiting for the release of the accompanying bill report to determine any implications for global health R&D. As we pointed out yesterday, it’s clear that many global health R&D programs are being flat-funded year after year. If Congress is unable to reach a long-term budget deal, sequestration cuts will take effect again, further hampering efforts to develop urgently needed new technologies. Congressional policymakers could still reverse this trend by fully funding global health and health research programs through the FY 2014 budget conference later this year, as well as through negotiations around the impending debate on the US debt ceiling. However, with the difficult political climate, it’s unclear whether they will take advantage of this important opportunity. Links to other helpful analyses: American Association for the Advancement of Science Alliance for a Stronger FDA

Wednesday, the White House released President Obama’s fiscal year (FY) 2014 budget request, which overall has mixed results for global health and research programs. Below, we provide specific details on funding levels at key agencies that support global health and research efforts, including the Centers for Disease Control and Prevention (CDC),the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Details are still forthcoming about how global health research fared at the Department of Defense. It’s important to note that figures are compared to final FY2012 levels, since Congress is still working on finalizing FY2013 levels. The president's budget for FY2014 requests funding for key US agencies engaged in global health product development. Credit: PATH. CDC CDC’s overall budget took a hit in the president’s request—the president’s FY2014 budget requested $5.2 billion for the agency overall, compared with $5.65 billion in FY2012. However, CDC’s global health programs were slightly increased and were spared major cuts. CDC’s Center for Global Health would receive $393 million in FY2014 under the president’s budget, compared with $376.7 million in FY2012. FDA The FDA got a much-needed increase in the president’s budget request, although much of it is due to an expected uptick in user-fee income. The agency would receive $4.65 billion in FY2014 under the president’s budget, compared with $3.83 billion in FY2012. As noted above, user-fee income plays a large part in this increase in FDA’s budget. User fees would comprise $2.09 billion of the agency’s budget under the president’s request, compared with $1.32 billion in user fees in FY2012. In recent years, Congress has not adequately appropriated stable funding to FDA, instead relying on user fees to make up the difference. Critics have said that relying on user fees is unsustainable and creates a conflict of interest between FDA and the industries it regulates. NIH NIH funding was mostly flat-lined at FY2012 levels—the president’s budget requested $31.3 billion for the NIH in FY2014, compared with $30.8 billion that the agency received in FY2012. The National Institute of Allergy and Infectious Diseases (NIAID), as well as the National Center for Advancing Translational Science (NCATS), received increases that could hint at new programming in those areas. The president requested $4.6 billion for NIAID in FY2014, compared with $4.5 billion the center received in FY2012. NCATS would receive $666 million under the president’s FY2014 budget, compared with $574 million in FY2012. State Department and USAID At USAID, several key programs that fund global health research were cut dramatically—most notably the agency’s tuberculosis (TB) program. Most other programs at USAID were flat-funded or saw small increases. Under the president’s budget, USAID’s global health programs would receive $2.645 billion in FY2014, which is pretty much the same figure ($2.649 billion) for FY2012. Under USAID’s global health programs, several key initiatives saw disappointing funding cuts. The TB program would be reduced to $191 million in FY2014, compared with $236 million in FY2012. The HIV and AIDS program would be cut to $330 million, compared with $350 million in FY2012. The neglected tropical diseases program would be cut to $85 million in FY2014, compared with $89 million in FY2012. Fortunately, the malaria program would see an increase to $670 million in FY2014, compared with $650 million in FY2012. The State Department budget element getting the most buzz is the 5.3 percent cut to the President’s Emergency Plan for AIDS Relief, while the Global Fund to Fight AIDS, TB, and Malaria saw a robust request of $1.65 billion for FY2014. Federal agencies have also released their budget justifications, which detail policy and programmatic priorities for FY2014. We’ll provide a comprehensive update on these budget justifications and key policies that could impact global health research and product development. Usually, the President’s budget request sets a precedent that the advocacy community and Congress respond to—whether they agree or disagree with its content. However, with the request being released so late in the year, Congress has already acted, passing drastically different FY2014 budget resolutions in the House and Senate. House and Senate budget committee activity is moving quickly, with key leaders from US agencies that fund global health research and product development scheduled to testify at appropriations hearings as early as next week. Congress must act to avoid further cuts and fund global health research programs at the robust levels that ensure availability of new technologies to the millions who need them worldwide.

Although we’re several days into sequestration, details about the full impact of funding cuts are still hazy. On Friday, the Office of Management and Budget (OMB) released a report to Congress, which details funding cuts required to offset $85 billion in the fiscal year (FY) 2013 budget. In order to reach this goal, the OMB report indicates that global health research and development (R&D) programs will be subjected to cuts of either 5 percent or 7.8 percent. But because the cuts must take place over a seven month period (instead of a full year) to fit within the fiscal year, OMB calculates that these cuts could actually be at a rate of 9 percent and 13 percent with the remaining funding for this year. OMB’s report provides some specific details on how the cuts are calculated. It also provides illustrative examples of what the sequestration cuts might look like if applied equally within federal agency budgets. However, because agency heads will have discretion over how specific cuts affect their agencies, the exact implications of sequestration will be determined in the coming weeks. Estimates are emerging regarding the widespread impact of sequestration on the agencies that support global health R&D. Photo credit: PATH While waiting for these details to come out, we are starting to see some estimates emerge regarding the impact of sequestration on the agencies that support global health R&D. For example: The National Institutes of Health’s discretionary budget will be reduced from $30,899,000 to $29,321,000 for FY13, a cut of over $1.5 billion. The sequester would equate to a $2.6 billion reduction to the State Department and US Agency for International Development (USAID) FY13 budget, translating to a $1.7 billion cut to foreign assistance programs. In particular, sequestration will cut over $400 million from global health initiatives at the State Department and USAID, including R&D initiatives. Global health programs at the Centers for Disease Control and Prevention are likely to be reduced by taking 5 percent from HIV and AIDS initiatives and then taking 5 percent from the remainder of the account. Discretionary spending for the Department of Defense (DoD) is subject to a 7.8 percent reduction, which would include any global health R&D initiatives embedded in DoD programs. Some reports indicate that the US Food and Drug Administration will lose about 9 percent of its budget for FY13. The Obama Administration is urging Congress to allow the agency to spend $41 billion-worth of user fees. In the meantime, the government is currently running on a Continuing Resolution, which expires on March 27. Congressional leaders and President Obama have expressed hopes about successfully negotiating a new spending bill by March 27, in order to avoid a government shut-down. These negotiations may also provide an opportunity to reverse the sequester, before the full impact of the cuts are felt across the government. The President’s budget request for FY14 is also on the horizon, with reports indicating that it might be released on March 25. The House and Senate will begin to take up FY14 budget resolutions, which each Chamber must pass by April 15. It’s becoming increasingly clear that sequestration is the wrong way to reduce the nation’s debt, especially when the impact would set back innovation and devastate global public health. Policymakers should use the upcoming budget negotiations as an opportunity to reverse sequestration and develop a long-term budget solution that protects and—where possible—increases funding for global health product development. Slashing funding will interrupt scientific progress and leave us without the urgent tools we need to address health needs now and in the future.