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Prepared Witness Testimony The House Committee on Energy and Commerce
Furthering Public Health Security: Project Bioshield
Subcommittee on Health
Mr. Michael Friedman MD
The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to share with this Subcommittee the views of the research-based pharmaceutical industry on the President's Project Bioshield Initiative. PhRMA represents the country's leading research-based pharmaceutical and biotechnology companies, which invested an estimated $32 billion in 2002 in developing new medicines to help and heal patients. PhRMA member companies join others who are convinced that biological weapons present a serious and increasing danger to people around the world. The pharmaceutical industry is dedicated to the development of innovative therapies and vaccines to counter unmet medical needs. Because a substantial proportion of the unmet medical need in the United States and worldwide is both directly and indirectly related to infectious diseases, we understand only too well the seriousness of the threat of biological agents if used as weapons of war. The complexity of the problem of biological weapons is best demonstrated by humanity's ongoing difficulty in dealing with infectious agents as the cause of natural disease, let alone their potential use for intentional concentrated exposure of selected populations. The threat represented by infectious diseases - such as HIV, malaria, and tuberculosis - is real and all too well demonstrated by the deaths of over 5 million people annually from these three diseases alone. All together, infectious diseases claim more than 100,000 American lives each year, and cost more than $30 billion annually in direct treatment expenses alone. At last count, PhRMA member companies were developing 256 new medicines to treat or prevent infectious diseases; medicines which include brand new classes of antibiotics, new vaccines (including edible vaccines), antifungals, antivirals, and immune enhancers. Reports from the National Academy of Sciences, the NIH Blue Ribbon Panel for Biodefense Research, and the US Defense Science Board, make clear that a large number of countermeasures to biothreats must also be developed. These countermeasures include vaccines, therapeutics, and diagnostics. The basic science research required for countermeasure development has already been stimulated by funds appropriated to various federal agencies including the Department of Health and Human Services and the Department of Defense. However it is widely recognized that more is needed with respect to funding of basic research, to increased authority for funding and regulatory agencies, and to the advanced development and production of the countermeasures. A cooperative and collaborative research and development effort, which engages industry, government, and academia, will be essential to that effort. Existing medicines are not sufficient to combat the biological weapons already developed. Research and development into new medicines is a lengthy, risky, and expensive endeavor. Research into biothreat countermeasures involves several challenges above and beyond those encountered in non-biodefense R&D. For example, biodefense R&D requires working with dangerous pathogens in highly specialized facilities, and developing countermeasures without a full picture of the risk of disease (because we cannot see into the mind of the terrorist) or the benefit of the treatment (because there are often no patients with the disease, which prevents clinical testing for efficacy). PhRMA and its member companies are already working closely with federal agencies and academia to move forward with this research. For example, PhRMA is working with CDC, DoD, NIH, FDA, and academia to support in vitro studies of five pathogens (B. anthracis, Y. pestis, Brucella spp., F. tularensis, and Burkholderia spp.) for testing of existing antibiotics. Several companies are working with the National Institute of Allergy and Infectious Diseases (NIAID), the Department of Defense, and the FDA to test existing antibiotics against plague, and PhRMA will cosponsor a workshop with interested parties to determine how best to expand labeling of other existing antibiotics that may be effective against the top biothreat agents. PhRMA committees continue to work with FDA to clarify and improve existing regulations that pertain to biothreat countermeasure research, such as Part 600 (the Spore Formers Rule, which imposes requirements on use of facilities or equipment that have been used with spore forming organisms), and the Animal Rule (which allows efficacy testing in animals where testing in humans would be impossible or unethical). We have prepared educational materials for the public on anthrax, smallpox, and vaccinia, and we are working on materials addressing tularemia and plague. Dr. Gail Cassell, PhRMA's Chief Scientific Officer for Emergency Preparedness and Vice President, Scientific Affairs at Eli Lilly & Co., sits on Secretary Thompson's Advisory Council on Public Health Preparedness. A Biosurveillance workgroup involving PhRMA and other private sector companies (TIGR, IBM, and Roche Diagnostics) along with federal agencies (CDC, DoD, NIH) and the World Health Organization to establish a global infectious disease electronic surveillance network. PhRMA believes that Project Bioshield, announced by President Bush in his 2003 State of the Union address, is an important step forward in the effort to ensure the development of modern, effective medicines and vaccines against biothreats and to ensure that these medicines are made available in a timely and efficient manner. PhRMA generally supports the three main components of the President's proposal: first, the creation of a permanent indefinite funding authority to spur the development of medicines and vaccines by the private sector; second, new authority for NIH to speed promising R&D through streamlined hiring and procurement mechanisms and increased flexibility to award contracts and grants; and third, new FDA emergency use authorization for promising treatments still under development. At the same time, however, it is necessary to recognize scientific, legal, and economic impediments to the research and development of biodefense products. Manufacturers may be exposed to devastating product-liability suits. Some of these would arise out of adverse events that are unavoidable given the nature of the products, and some could arise simply because the products were made available without the usual battery of clinical trials required for FDA-approved products. Private insurance can be unavailable or prohibitively expensive for such products. The decision to divert resources from the research and development of medicines for serious illnesses like heart disease can be financially risky, especially when a countermeasure may never be purchased or used, and especially for companies with few products in the pipeline. (Diverting resources from research and development of these other medicines will also affect the future availability of treatments and cures for patients with other serious health conditions - especially since less than ten percent of all drugs that enter testing ever demonstrate sufficient safety and acceptable efficacy.) The need for urgent development of medicines may require the sharing of information and cooperation among companies, which can raise antitrust concerns. The scientific challenges inherent in research into bioterrorism countermeasures, for example, may require cooperation and collaboration among scientific experts in different companies. (For example, there have been only two new classes of antibiotics developed in the last 40 years.) PhRMA looks forward to working closely with Congress and the Administration to enact measures that will provide appropriate product liability protection and address these antitrust constraints. Cooperation and strong commitment from all parties will be necessary in the months and years to come, as our nation seeks to protect itself against the terrible threats of biowarfare and bioterrorism. America's pharmaceutical companies look forward to doing our part. We thank you for your time and look forward to answering your questions.
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