Reading Room Production — page 465

Draft Strategy for Reinventing the Integrated Public Health Emergency Medical Countermeasures Enterprise The U.S. Government's Integrated Public Health Emergency Medical Countermeasures Enterprise (iPHEMCE) has struggled for almost a decade to develop drugs, diagnostics, and vaccines ("countermeasures") against naturally occurring pandemics and other infectious diseases, and deliberately propagated bioterrorism and other public health threats. Despite significant investment, our National efforts have yielded only a modest number of new countermeasures. We recognize that our current approach is not sustainable over the long term, will not provide us with the comprehensive protection we require against both known and emerging threats, and that recent advances in the biological sciences and pharmaceutical industry create scientific opportunities that must be pursued. (Excellent! To reduce our vulnerability to public health threats and safeguard the health and safety of the American people, we must pursue immediately a-very different approach to novel medical countermeasures development and acquisition. To that end, and as announced during the President's State of the Union address on January 27, 2010, the Obama Administration is launching a transformative initiative. The goal is to develop a national capability for the rapid, reliable, robust, and affordable production of an array of medical countermeasures against public health threats. This document lays out the broad strategy to achieve this goal. 'Commented [a1]: I inserted the word "broad" to alleviate the In creating a transformed iPHEMCE, it is useful to understand the obstacles that have limited its success to date. In pursuing new biodefense countermeasures over the last eight years, the Federal Government has experimented with a variety of "push" and "pull" incentives for the pharmaceutical industry, a critical partner in the development of countermeasures. These incentives, including the creation of a $5.6B Special Reserve Fund for Project BioShield, have not resulted in the desired flow of new and next-generation medical countermeasures because they have not addressed the real problem, which is the barriers that the pharmaceutical industry perceives to return on investment in this area. These barriers include: '* Complex, burdensome, and uncertain path to licensure of countermeasures; Rapid and unpredictable pace of new requirements for novel countermeasures; Small markets and/or low profit margins for the products the USG has indicated it requires: High cost of drug development under any circumstances; High costs associated with scale-up and manufacturing: Limited in-house subject matter expertise: Lack of expertise and experience in negotiating the U.S. Food and Drug Administration (EDA) "animal rule" pathway to product licensure: © Complex policy environment; © Complex funding environment; and © High risk of failure. Afier assessing the high opportunity cost and financial risk of working in the domain of developing countermeasures for bioterror threats, and considering the high transaction costs associated with government contracts, capable large pharmaceutical firms have uniformly elected to focus their ty that this is final and to Stil specifics to be ironed out. afauci 2010-02-11 19:37:00 by the that there are