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Testimony

Statement by
Robin Robinson  Ph.D.
Deputy Assistant Secretary
Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

on
The HHS Role in Medical Countermeasure Development and Acquision 

before
Committee on Appropriations
Subcommittee on Defense
United States House of Representatives


Thursday April 24, 2008

I. Introduction

Mr. Chairman and Members of the Subcommittee, I appreciate the opportunity to join you today to testify on behalf of the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), where I serve as the newly-appointed Deputy Assistant Secretary for the Biomedical Advanced Research Development Authority (BARDA). Prior to this position, I was the BARDA Deputy Director for the Influenza & Emerging Disease Program, where we implemented the strategic plans and policies for medical countermeasures outlined in the National Strategy for Pandemic Influenza.

I look forward to working with Congress in my new role, hoping to build upon the successes of the pandemic-influenza preparedness program as we focus on the broader chemical, biological, radiological and nuclear (CBRN) threats portfolio.

II. Bioterrorism Preparedness: HHS Role(s)

As you know, the role of medical countermeasures is critical to our national preparedness against the threats associated with CBRN and pandemic-influenza. However, medical countermeasure development and acquisition is only one component of our overall efforts to be prepared against all-hazards. Our all-hazards preparedness involves a shared responsibility among our entire Department, our partners in the international community, the Federal interagency, state, local, tribal and territorial governments, the private sector, and, ultimately, individuals and families. For instance, we support state and local authorities through the State and Local and Hospital Preparedness programs and the Public Health Emergency Preparedness program for a broad range of medical and public health preparedness activities, including the development of medical and public health plans for response, establishment of local stockpiles of critical medical equipment and supplies, improvement of surveillance and investigation capabilities, maintenance and distribution of countermeasures, and sharing of resources.

Our progress in securing medical countermeasures begins with and depends on effective planning. The central framework for medical countermeasures planning and implementation in the Federal government is the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), established in July 2006. This coordinated interagency group is led by the Assistant Secretary for Preparedness and Response (ASPR), and includes the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) as well as our partners from the Department of Defense, Department of Homeland Security, and Department of Veterans Affairs. Through this Enterprise-wide effort, we are able to ensure that Federal activities with respect to needed medical countermeasures are effectively coordinated from research and development to acquisition and ultimately deployment. This supports a range of programs that I will briefly summarize for developing and acquiring medical countermeasures for man-made and naturally-occurring public health threats while building domestic manufacturing infrastructure.

Anthrax: Anthrax remains a top priority for ongoing public health emergency preparedness efforts at HHS. The Department is committed to developing and acquiring a robust, comprehensive portfolio of medical countermeasures against this threat.

Antibiotics represent the first line of defense to protect the nation following an anthrax attack. Today, we have over 60 million courses of antibiotics on hand and on order for the Strategic National Stockpile (SNS). Anthrax vaccines are also an essential element of our national preparedness. It is possible that vaccines given as post-exposure prophylaxis in combination with antibiotics could provide longer-term protection, or allow for a reduction in the duration of the antibiotic regimen. HHS has awarded contracts for the acquisition of nearly 30 million doses of anthrax vaccine since 2005, including the recent contract award of 18.75 million doses of Anthrax Vaccine Adsorbed (AVA, BioThrax™) in partnership with the DoD. In addition, antitoxins are necessary to treat individuals with advanced stages of infection, and may contribute to a more successful therapeutic outcome. Beginning in 2007, HHS has awarded contracts to two manufacturers to deliver antitoxins sufficient for treating 30,000 people. These vaccine and antitoxin contracts were awarded under the authorities of the Project BioShield Act of 2004. In addition, three BARDA contracts for the advanced development of other anthrax therapeutic candidates were recently awarded through a partnership with the NIH/ National Institute of Allergy and Infectious Diseases (NIAID).

HHS remains committed to the development and acquisition of a second generation anthrax vaccine. While procuring and continuing to improve the currently available anthrax vaccine, HHS is investing over $40 million in the continued development of a recombinant anthrax vaccine. This investment builds on the recombinant vaccine program that has been ongoing at the NIAID since 2002. BARDA also released a Request for Proposals (RFP) in March 2008 for a recombinant anthrax vaccine contract award. In addition, BARDA and NIAID released a Broad Agency Announcement in September 2007 for vaccine enhancement that will support important improvements in storage conditions and administration for vaccines against a wide array of biological threats; these proposals are currently under USG review.

Smallpox virus: In June 2007, BARDA awarded a contract for a next generation modified vaccinia Ankara (MVA) smallpox vaccine for use in immune-compromised Americans. This was the first BARDA contract to utilize performance-based milestone payments allowable under the Pandemic and All Hazards Preparedness Act (PAHPA). HHS/CDC has also procured ACAM-2000, a live, single-dose smallpox vaccine developed by Acambis, which is the first new bio-defense vaccine to be approved by the FDA.

Botulinum toxin: In June 2006, HHS awarded a contract under Project BioShield to the Cangene Corporation for 200,000 doses of a botulinum antitoxin that targets all 7 serotypes of Clostridium botulinum. The $363 million contract will expand greatly our existing stockpiles in the SNS. Deliveries of this product to the SNS initiated in 2007.

Radiological/Nuclear: We hold significant stockpiles of supplies to treat many of the complex aray of medical problems following a potential radiological or nuclear attack, including antibiotics, anti-nausea drugs, and quantities of supplies to treat burn and blast injuries. We have procured medical countermeasures to mitigate the effects of radiation exposure from either dirty bomb scenarios (Prussian blue and DTPA) or resulting from accidents or deliberate attacks involving nuclear power plants (potassium iodide (KI) in both tablet and liquid forms). In addition, in order to acquire therapeutics to treat the effects of bone marrow suppression associated with the acute radiation syndrome (ARS) that might result from a nuclear blast, BARDA released an RFP in March 2008. Lastly, BARDA released a Broad Agency Announcement in May 2008 for early-stage product development and partnered with NIAID to fund advanced development of these medical countermeasures and for necessary testing facilities.

This enterprise approach has been successful as HHS prepares the Nation for the threat of an influenza pandemic, and we can transition this model into our CBRN portfolio going forward. Using some of the specific examples of accomplishments in the pandemic influenza program, I’m beginning to redefine how we, at HHS, along with our Federal partners, can coordinate to achieve the necessary measures to develop, acquire and establish stockpiles, expand domestic manufacturing surge capacities for vaccines, antiviral drugs, rapid diagnostics, and non-pharmaceutical countermeasures including respiratory devices.

III. Summary of Pandemic Influenza-Related Accomplishments

The pandemic influenza program is focused on vaccines, antivirals, diagnostics, and non-pharmaceutical countermeasures. In December 2005, and June 2006, Congress appropriated $5.6 billion for HHS pandemic influenza preparedness efforts. With these funds, scientists and public health experts at HHS have built an aggressive and broad-based medical countermeasures program for pandemic influenza. These funds support the acquisition of existing products, advanced development projects to produce modernized and next-generation countermeasures, and the retrofitting and construction of the facilities necessary to produce pandemic influenza vaccines.

With respect to vaccines, HHS has a number of efforts underway. These efforts supported the first U.S. licensure of an H5N1 vaccine in April 2007, which was highlighted as the number one medical breakthrough of 2007. By the end of 2007, HHS in coordination with DoD had stockpiled 12 million courses of pre-pandemic H5N1. However, maintaining a domestic production capability for these priority countermeasures is also an essential component of the pandemic influenza preparedness strategy. In May 2006, HHS awarded five contracts for over $1 billion to GlaxoSmithKline, MedImmune, Novartis (formerly Chiron), Solvay, and Dynport (with Baxter) for support of advanced development of cell-based influenza vaccines toward U.S. licensure and expanded domestic vaccine manufacturing surge capacity. In June 2007, we awarded two contracts for the retrofitting of existing domestic biological manufacturing facilities to produce egg-based influenza vaccines and included warm base operations for up to five years. Additionally, contract awards are expected in 2008 for the construction of new domestic facilities for manufacturing cell-based influenza vaccines that is expected to quadruple the domestic pandemic vaccine manufacturing surge capacity by 2012.

A robust and groundbreaking advanced development program has led to the rapid maturation of modernized cell-based influenza vaccine production and antigen-sparing technologies. New combinations of adjuvants and products provided by multiple manufacturers are currently supported by performance-driven milestone contracts. More rapid vaccine production may be afforded by the development of next generation recombinant influenza vaccines, which HHS will support in FY2008.

Antiviral drugs have become an increasingly important medical countermeasure for influenza. Today, in coordination with DoD and VA, the SNS contains 50 million treatment courses of antiviral drugs, completing the Federal stockpile one year ahead of schedule. HHS has also supported antiviral stockpiling at the state level. Through a federally subsidized program, states have purchased 22 million treatment courses of influenza antiviral drugs to date and are expected to reach our goal of 31 million courses by the end of 2008.

The nature of severe influenza infections has also required us to focus on preparedness through non-pharmaceutical countermeasures, such as ventilators which play an essential role in the health care of critically ill patients. The FY 2009 President’s Budget includes $25 million to develop ventilators that are more amenable to public health emergency use. This presents a prime example of the integrative, all-hazards approach that the PHEMC Enterprise seeks. A more portable and easier to use ventilator could be an essential tool for responding to many different public health threats, when having a sufficient supply of ventilators could have an impact on the morbidity and mortality of exposure.

IV. Learning from Pandemic Influenza: A Portfolio Approach to CBRN Preparedness

As I outlined, we’ve learned much from our pandemic influenza preparedness activities over the last three years, and as the Director of BARDA, I appreciate the challenges that applying these lessons to a broader portfolio of CBRN will bring.

HHS established the Biomedical Advanced Research and Development Authority (BARDA) to direct and coordinate the Department’s countermeasure and product advanced research and development activities. In support of the mission and priorities of the HHS Public Health Emergency Medical Countermeasure Enterprise, (PHEMCE), BARDA establishes systems that encourage and facilitate the development and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of chemical, biological, radiological and nuclear (CBRN) agents and emerging infectious diseases, including pandemic influenza. BARDA provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health emergencies. It directs and coordinates the Department’s countermeasure and product advanced development activities and medical countermeasure domestic manufacturing infrastructure building, including strategic planning for medical countermeasure research, development, and procurement. This coordinated approach is critical to achieving success in the area of bioterrorism preparedness.

V. Integration with Federal Partners: A Coordinated Model for National Activities

HHS, through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) began a process that brings together federal partners for decision-making along the lifecycle of a medical countermeasure. We also are working on a process that expands this concept of coordination, to discuss the strategy behind the development of priorities and portfolios. One of our principal colleagues for this dialogue is the Department of Defense, given our complementary missions in providing an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Indeed this week BARDA and DoD are sponsoring a symposium to coordinate activities for rapid diagnostics to detect novel influenza viruses. Our stakeholders are civilians and DOD’s are military personnel, but these joint analyses allow us the opportunity to not only reference one another’s portfolios, but also develop synergistic approaches to our planning, like stockpiling. Currently HHS/CDC and DOD are maintaining joint stockpiles of both AVA and ACAM2000 and using similar contracts for H5N1 vaccines and influenza antiviral drugs.

We appreciate the partnership throughout the Federal government and recognize it is a key to success with medical countermeasures as well as bioterrorism preparedness in general.

Thank you for the opportunity to share this information with you. I am happy to answer any questions.

Last revised: June 18, 2013