Nearly 5,000 people have been killed in the outbreak of Ebola in West Africa, mostly in Guinea, Liberia and Sierra Leone. As reported by the World Health Organization (WHO), there are now more than 13,000 confirmed, suspected and probable cases, almost all in these countries. However, cases have been reported also on a small scale in Nigeria, Senegal, Spain and the United States. Most recently, a new outbreak has been identified in Mali, which authorities are working aggressively to contain.
There may be good news—the WHO and other officials believe that the overall number of new cases may be leveling off, with a decrease to around 1,000 new cases each week. Yet, such a distressingly high incidence is still a major concern and poses a continued threat of new Ebola cases in the United States.
For the Administration and Congress, the Ebola response represents a shared and immediate priority for humanitarian reasons and global health security. On the day following the elections, the President submitted a $6.18 billion appropriations request to Congress. Of the $2.43 billion requested for the Department of Health and Human Services (HHS), $333 million is allocated for the Public Health and Social Services Emergency Fund, including $157 million for the Biomedical Advanced Research and Development Authority (BARDA); $238 million for the National Institutes of Health (NIH); $1.83 billion for the Centers for Disease Control and Prevention (CDC); and $25 million for the Food and Drug Administration (FDA). The remainder of the funding would support complementary and critical efforts by the Departments of State, Defense and Homeland Security.
In response to the President’s request, the Senate and the House of Representatives have begun to conduct a number of hearings to explore and assess various aspects of the pandemic, with dual focus on the response to date and what is to come. The continuing resolution that provided initial funding for the Ebola response expires on December 11, lending some urgency to the debate.
Top Five Issues:
Despite the dynamic nature of the outbreak, there are at least five core health concerns that policy-makers in the Administration and Congress are working to address:
- Pipeline of vaccines, therapeutics and diagnostics: Currently, there are no FDA-approved vaccines or treatments for Ebola. The federal agencies, including NIH, CDC and BARDA, as well as the Department of Defense’s (DOD’s) Defense Threat Reduction Agency and Defense Advanced Research Projects Agency, have accelerated research to develop and test the safety and effectiveness of medical products, including those already in experimental use. Encouragingly, at least two vaccines may be ready for large scale testing in humans in early 2015. In addition to pipeline concerns, policy-makers have focused on obstacles to commercialization, including needed funding and the nature of contractual agreements between BARDA and manufacturers. Another important topic has been what, if any, additional authorities are needed to expedite approval of these products through the FDA.
- Public health infrastructure: Policy-makers are concerned about and seek to better understand vulnerabilities within the nation’s preparedness system across the continuum of issues. In particular, greater scrutiny has been given to the CDC’s three-tiered approach for screening for those entering the United States, including questioning and checking for fever at ports of entry, and self-monitoring for those potentially at risk. The CDC has strengthened domestic and international public health infrastructure capabilities, including laboratory networks, surveillance systems, isolation capacity and emergency operations, in part through implementation of the Global Health Security Agenda. The U.S. Agency for International Development at the Department of State (State) has partnered closely with CDC to provide the “on-the-ground” response.
- Quarantine issues: A number of states, including New York, New Jersey and Maine, and the Department of Defense (DOD) have implemented quarantine protocols that are not aligned with recommendations from HHS. Given these dissonant messages, policy-makers will continue to debate the circumstances of when such quarantines may be helpful in preventing the spread of disease.
- Medical care: Policy-makers have been challenged to increase and enhance provider training and safety, especially for nurses and other front-line staff. Availability of personal protective equipment (PPE) is an important part of this dialogue—federal officials are working with manufacturers to maximize production of PPE, some of which will be stored in the Strategic National Stockpile at CDC. With regard to hospitals, federal officials support patient transfers to hospitals with biocontainment units and advanced care capabilities. However, raising the standard of Ebola care for those hospitals that are likely to encounter infected patients, such as those in the vicinity of the five airports through which the majority of travelers from West Africa enter the United States, is a priority as well. Funding support for such hospitals and reimbursement for direct patient care has been part of this policy discussion. Finally, evidence-based clinical care guidelines for Ebola are needed as the physician experts are unsure about what care is most effective.
- Leadership and collaboration: Given the critical roles of multiple federal departments, including HHS, State, DOD, the Department of Homeland Security (DHS), and agencies within such departments, the role of the Ebola Czar, Ron Klain, has garnered much interest. Further, policy-makers are focused on U.S. collaboration with leading global health entities, especially the WHO, non-governmental organizations and major philanthropies. How the United States can facilitate greater participation, cooperation and funding support on a global platform will remain a key policy goal.
To date, several congressional committees have conducted hearings on the Ebola crisis, including the Senate Committees on Appropriations and Health, Education, Labor and Pensions (HELP) and the House Committees on Foreign Affairs, Energy and Commerce, and Oversight & Government Reform. A recent Senate Appropriations Committee hearing, under the leadership of Chair Barbara Mikulski (D-MD), included the following Administration witnesses: Secretary of HHS, Sylvia Mathews Burwell; Director of the CDC, Dr. Thomas Frieden; Director of the National Institute of Allergy and Infectious Diseases (NIAID) at NIH, Dr. Anthony Fauci; Secretary of Homeland Security, Jeh Johnson; Deputy Secretary of State, Heather Higginbottom; and Assistant Secretary, Special Operations and Low Intensity Conflict, DOD, Michael Lumpkin.
Senate HELP Committee Chair Tom Harkin (D-IA) and Ranking Republican Member Lamar Alexander (R-TN) are expected to introduce legislation to accelerate the “development of treatments and vaccines” by adding Ebola to the FDA’s “priority review voucher program” which is “designed to incentivize the development of new drugs for neglected tropical diseases.” The Harkin-Alexander bill would add Ebola to the list of tropical diseases covered by this program.
Two Energy and Commerce Subcommittees, under the leadership of Oversight and Investigations Subcommittee Chair Tim Murphy (R-PA) and Health Subcommittee Chair Joe Pitts (R-PA), will hold Ebola hearings on November 18 and 19. The Oversight hearing will focus on public health issues related to Ebola and the Health hearing will concentrate on medical product development in response to the Ebola epidemic.
Combating the Ebola crisis will be a high priority of the 114th Congress. We expect key Senate and House leaders to continue their focus on this issue over the next two years. Actions taken by the Congress will have implications for a wide range of stakeholders, including hospital and provider groups, the vaccine, pharmaceutical and diagnostics industry, manufacturers and employers, all of whom have critical roles to ensure high quality care for patients in need.
If you have any questions regarding this update, please contact the Sidley lawyer with whom you usually work or
Dora L. Hughes, MD, MPH
The Government Strategies Practice of Sidley Austin LLP
To receive future copies of this and other Sidley updates via email, please sign up at www.sidley.com/subscribe.
Sidley Austin provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.