Furthering Public Health Security: Project Bioshield

House Committee on Energy and Commerce: Subcommittee on Health
Subcommittee on Emergency Preparedness and Response of the Committee on Homeland Security
March 27, 2003
09:30 AM
2123 Rayburn House Office Building

On behalf of AdvaMed's (the Advanced Medical Technology Association) Medical Technology Preparedness Council, I am pleased to provide testimony in support of Project BioShield. My name is Dr. Gary Noble and I am Vice President for Medical and Public Health Affairs at Johnson & Johnson, where I serve on the company's Emergency Preparedness and Business Continuity Task Force. I also spent 29 years at the Centers for Disease Control and Prevention working in the areas of infectious disease, public policy and legislative affairs.

Johnson & Johnson develops a wide range of health care products, including devices, such as surgical supplies, diagnostic instruments and assays, and products used to ensure the safety of the blood supply.

AdvaMed represents more than 1,100 innovators and manufacturers of medical devices, diagnostic products and medical information systems. Our members produce nearly 90 percent of the $75 billion in health care technology products consumed annually in the United States and nearly 70 percent of $170 billion purchased around the world annually. Many of these technologies - such as rapid tests to diagnose diseases caused by bioterrorism, gels and foams that can rapidly close wounds, bioengineered skin products for burn victims, and information systems to communicate critical public health information - form an important part of a timely, effective response to terrorist attacks.

AdvaMed's Medical Technology Preparedness Council

In response to the events of September 11, 2001, AdvaMed established the Medical Technology Preparedness Council to assist federal agencies in ensuring that the health care delivery system is fully prepared. The Council, established in October 2001, meets regularly to discuss issues and concerns, and has begun to work with key government preparedness entities including the Office of Emergency Preparedness (OEP), the Secretary's Command Center, the Food and Drug Administration (FDA), the Metropolitan Medical Response System (MMRS), and with individuals at the Centers for Disease Control and Prevention (CDC) who were administering the Strategic National Stockpile, among others.

We strongly support the principle of a public-private partnership in the area of preparedness. AdvaMed sponsored a sold-out conference on February 6, entitled "Innovation for Preparedness: the Public-Private Partnership," to strengthen the partnership between the government and the private sector on preparedness and to connect medical technology innovators with appropriate federal preparedness entities. Representatives from key preparedness entities within the federal government, including OEP, CDC, FDA, the Department of Defense, the National Institute of Allergy and Infectious Diseases (NIAID), the Department of Defense, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) and the Environmental Protection Agency participated in the conference.

Medical Technology: Key to Rapid and Effective Response

Many of the technologies our companies manufacture or are developing are integral to a rapid and effective response to any potential terrorist attack, including among others:

Diagnostic Tests: In November 2001, Roche Diagnostics and the Mayo Clinic announced the development of a new rapid anthrax test that can detect anthrax in humans in an hour and quickly made the test available to public health agencies and hospital and reference laboratories. Companies are working to develop diagnostic tests for other bioterrorist infectious agents, including smallpox. AdvaMed and its companies are also working cooperatively with FDA and the CDC to speed development of a diagnostic test for West Nile virus. � Vaccine and Drug Delivery Devices: "Microdelivery" devices in development by BD will deliver vaccines more efficiently and effectively, allowing better absorption by the body and at the same time extending vaccine supply. For example, in collaboration with USAMRIID, researchers have shown that use of these skin-based microdelivery technologies can significantly improve the performance of next-generation recombinant protein vaccines against anthrax and the organism that causes toxic shock.
Biochemical Decontamination Technologies: We saw the importance of technologies to decontaminate large contained areas and their contents, sensitive electronic equipment, mail and other items after the anthrax attacks of 2001. STERIS Corporation and the U.S. Army Edgewood Chemical Biological Center have entered into a collaborative research and development project to evaluate, optimize and modify STERIS's Vaporized Hydrogen Peroxide (VHP�) technology and to demonstrate its effectiveness against biological and chemical warfare agents.
Blood Safety Technologies: Companies continue to work on technologies to protect our blood supply through inactivation or pathogen removal technology to inactivate or eliminate blood-borne viruses, parasites, lymphocytes and bacteria from blood products.
Advanced Burn and Wound Care Technologies: Companies have developed gels and foams that can rapidly close wounds and bioengineered skin for the treatment of second and third degree burns. On September 11th 2001, Smith and Nephew, Inc. employees personally drove bioengineered skin products to New York City and Washington, D.C. to ensure patient access to these critical technologies despite the disruption to the distribution and supply chains because of U.S. airspace closures.
Health Information Systems: Coordination of information by local, state and national public health authorities is key for managing efficient immunization activities and detecting biological outbreaks. Specialized vaccination tracking systems being developed by BD and others can help document and manage adverse events to vaccines while assuring rapid, safe vaccine deployment. As a measure of the critical role health information systems can play, last Friday, the Department of Health and Human Services (HHS) announced that it will begin testing a system using handheld personal digital assistants (PDAs) for transmitting urgent information about biological agents to clinicians. The three-month pilot test is designed to gauge the best ways for federal officials to communicate effectively with front-line clinicians in the event of a bioterrorist attack.
Basic Medical Technologies: Basic medical technologies are also essential during times of crisis including ventilators, imaging technologies and infusion and monitoring equipment among others as well as gowns, gloves, masks and respirators to protect health care workers. A November 2001 JAMA article co-authored by Anthony S. Fauci, M.D. attributes the reduction in mortality in the inhalation anthrax cases to technological advances in diagnostics, imaging, microbiology, antibiotics and critical care.

AdvaMed Supports Project BioShield

AdvaMed strongly supports the Project BioShield initiative. Recent media reports confirm that some terrorist groups have the willingness to use bioterror agents and have been trying to develop the capability to launch infectious agents. Additionally, the rapidity of the global spread of severe acute respiratory syndrome (SARS) highlights the vulnerabilities we face.

Specifically, AdvaMed's Council supports provisions in Project BioShield that will:

Speed research and development on biomedical countermeasures by streamlining current NIH processes and providing funding for the construction and improvement of facilities needed to safely support research and development of countermeasures;
Provide necessary funding to purchase biomedical countermeasures for the stockpile particularly those countermeasures determined not to have commercial markets; and
Allow the Secretary to make promising treatments available in an emergency, even for those products that do not yet have full FDA approval.

Project BioShield Should Include All Medical Technologies

Qualified Countermeasures. It is critical that all medical technologies - including devices, diagnostics and health information systems - be eligible for inclusion in all aspects of Project BioShield. The proposal submitted to Congress by the Administration provides significant discretionary authority for the Secretary of HHS to identify specific countermeasures to threats that would be appropriate for procurement and for inclusion in the national stockpile. The Secretary must annually determine whether such countermeasures have a significant commercial market other than as homeland security countermeasures. The Secretary should have the clear authority to include all medical technologies in these determinations.

While many focus on vaccines as the sole countermeasures needed to counteract bioterror agents, as we saw with the inhalation anthrax cases and are seeing again with SARS, the ability to diagnose individuals to determine who has been exposed is essential to treatment and to limiting the contagious spread of infection. Additionally, in the case of the anthrax attacks in the Senate Hart Building, the Brentwood Postal facility and others, as manufacturers continue to develop rapid tests like the Roche-Mayo Clinic anthrax test, they hold the promise that many individuals will be able to forego prophylactic antibiotic or other treatment. And as diagnostic tests advance, we will be able to detect those who have been exposed and are infectious yet are not exhibiting any signs of illness -- as some are speculating is the possibility with SARS.

In the event of a bioterrorist attack, it will be critically important to ensure that all of the elements essential to treatment - diagnostic tests, specialized syringes and needles to deliver vaccines, information systems to assure safe and rapid vaccine deployment, and more -- are delivered along with the vaccines. We strongly recommend that in drafting BioShield legislation, the Committee extend to the Secretary the authority to consider all medical technologies, including devices, in determining what technologies are needed to protect our nation from potential bioterrorist events.

Medical Products for Use in Emergencie. The proposal submitted to Congress by the Administration would extend authority to the Secretaries of HHS and Defense to declare a national, public health or military emergency justifying the authorization of a drug or device if they determine that it may be effective in detecting, diagnosing, treating or preventing a serious or life-threatening condition. They must also determine that the known and potential benefits of the product outweigh the known and potential risks of the product and that there is no adequate, approved and available alternative.

The Secretaries should have the ability to consider all medical technologies for use in emergencies. For example, most diagnostic tests are reviewed through FDA's 510(k) process. A test approved to detect a specific bacterium or viral agent may be modified to detect another bacterium or virus of the same family. FDA's 510(k) process recognizes that diagnostic test development is an iterative process that builds on the knowledge

gained from the previous infectious agent to develop tests for similar agents. Thus, it is conceivable that a previously approved diagnostic test may also prove to be useful in screening some bioterrorist agents. The value of this process is not limited to diagnostic tests but is the mainstay of all 510(k) products.

We strongly recommend that the Committee draft legislation that is broadly inclusive of all medical technologies, including 510(k) products. In the event that a product might have a needed countermeasure application, it should not be excluded because of a technicality.

Need for Strong Liability Protections

AdvaMed encourages the inclusion of strong liability protections for all aspects of Project BioShield, including medical devices. Presumably, those products that are declared qualified countermeasures under Project BioShield would also be declared qualified anti-terrorism technologies under Section 861 of the Homeland Security Act and would thus be eligible for the liability protections of that Act. However, it is not clear that companies whose products are declared for use in national, public health or military emergency situations would be eligible for the Section 861 protections. Such products, by definition, have not yet been reviewed or approved for use by FDA. Liability concerns will be a key consideration for companies manufacturing both qualified countermeasures and emergency-use products and the legislation should make clear that the liability protections of Sec. 861 of the Homeland Security Act apply to such products.

Importance of Assuring Adequate Supplies in the Event of a Significant Attack

As the Committee works on Project BioShield and assuring the availability of medical technologies to protect and treat patients, we also recommend that the Committee be mindful of the problems that can arise during a crisis in getting these technologies to patients. In the wake of a significant attack or disaster, it will be necessary to ensure that local providers are adequately supplied with appropriate medical equipment to care for casualties. As part of the AdavMed's preparedness efforts, we have invested significant time and resources in working with the appropriate federal authorities to ensure that the needed medical materials and supplies will be available.

There is a critical initial period of 12-24 hours during which most supplies will come from local stocks in hospitals, other health care facilities, and local distributors. However, after that initial period, there will be a need to resupply these facilities. Local planners in particular seem to take the approach that "if it is needed, it will appear." AdvaMed has worked with Office of Emergency Preparedness and MMRS regarding the logistics of moving medical supplies to the scene of a major attack. Our objective has been to make planners at all levels aware of the issues around resupply and to provide advice about who to contact for resupply.

AdvaMed has worked closely with related trade associations, the Health Industry Distributors Association (HIDA) and the Association for Healthcare Resources and Materials Management (AHRMM) to develop a planning guide for state and local emergency planners that explains medical supply chains and logistics. The guide is currently being printed and details are being worked out for the physical distribution to members of the National Emergency Management Association (NEMA), the Association of State and Territorial Health Officials (ASTHO), and the National Association of City and County Health Officials (NACCHO). A prototype of this booklet is attached for your information.

AdvaMed has also supported the efforts of the AHRMM, HIDA and the Health Industry Group Purchasing Association (HIGPA) in the development of supply formularies. The formularies, which vary depending on whether the incident is chemical, biological, radiological, explosive, etc., are intended to act as a benchmark for emergency supply preparedness. They can be customized to meet the individual needs of hospitals and the communities they serve.

AdvaMed is also concerned about "business continuity" and the potential vulnerability of certain sites that monitor manufacture critical medical supplies. These sites may be the sole source for certain supplies. If these sites are incapacitated for whatever reason, critical supplies essential to quality health care may not be available. Ways to address this dilemma include establishment of alternative site manufacturing capacity as well as stockpiling additional inventory. We recommend that the Committees consider this issue and that the Department of Homeland Security's Office of Information Analysis and Infrastructure Protection be charged with examining solutions that would provide incentives for industry to create back-up capacity or such other solutions as may be appropriate, including use of the Strategic National Stockpile.

Conclusion

We thank the Chairman for holding this hearing today and we appreciate the opportunity to provide testimony. During this time of national crisis, the Medical Technology Preparedness Council stands ready to work with the federal government to achieve our mutual goals of defending the homeland from terrorist attacks and providing the best medical care possible for our citizens. We also look forward to working with the Committee to assure the enactment of BioShield legislation consistent with our testimony. I would be happy to answer any questions that the Committee may have.

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