Matheny Jason, Mair Michael, Mulcahy Andrew, Smith Bradley T
Biosecur Bioterror. 2007 Sep;5(3):228-38. doi: 10.1089/bsp.2007.0030.
Therapeutics and vaccines are available for only a fraction of biological threats, leaving populations vulnerable to attacks involving biological weapons. Existing U.S. policies to accelerate commercial development of biodefense products have thus far induced insufficient investment by the biopharmaceutical industry. In this article, we examine the technical, regulatory, and market risks associated with countermeasure development and review existing and proposed federal incentives to increase industrial investment. We conclude with several recommendations. To increase industry's engagement in biodefense countermeasure development, Congress should expand BioShield funding, giving HHS the flexibility to fund a portfolio of biodefense countermeasures whose revenues are comparable to those of commercial drugs. Congress should establish tradable priority review vouchers for developers of new countermeasures. A National Academy of Sciences or National Biodefense Science Board should formally evaluate incentive programs and a government-managed "Virtual Pharma," in which HHS contracts separate stages of research, development, and production to individual firms.
治疗方法和疫苗仅适用于一小部分生物威胁，这使得民众容易受到涉及生物武器的攻击。美国现行的加速生物防御产品商业开发的政策，到目前为止在生物制药行业引发的投资不足。在本文中，我们研究了与对策开发相关的技术、监管和市场风险，并审视了现有的以及提议的联邦激励措施，以增加产业投资。我们最后提出了几点建议。为了增加行业对生物防御对策开发的参与度，国会应扩大生物盾牌计划的资金投入，赋予美国卫生与公众服务部（HHS）为一系列生物防御对策提供资金的灵活性，这些对策的收益应与商业药物相当。国会应为新对策的开发者设立可交易的优先审评券。美国国家科学院或国家生物防御科学委员会应正式评估激励计划，以及一个由政府管理的“虚拟制药公司”，在这个模式中，美国卫生与公众服务部将研究、开发和生产的不同阶段外包给各个公司。
