Developing Biodefense Countermeasures: Lessons from the Orphan Drug Act and Project BioShield Anthrax Contracts

US preparedness for a potential bioterrorist attack must include a comprehensive stockpile of countermeasures against biological agents. The Project BioShield Act was enacted in 2004 to promote the development of biodefense countermeasures. Under the act, however, only a limited number of such products have successfully been developed and none have yet received regulatory approval. This dissertation seeks to understand the barriers and ineffective incentives that challenge the development of such countermeasures by analyzing the following: 1) Evaluation of factors (technical, regulatory, economic, legal, political and military) surrounding the development of biodefense products; 2) Comparison of the impact of two acts with the aim to incentivize the development of products with little market appeal: Project BioShield and the Orphan Drug Act; and 3) Comparison of four companies with a BioShield anthrax contract in a multiple-case study. The purpose of these analyses is to identify opportunities to remove barriers that challenge the development of biodefense countermeasures. This dissertation finds that the most critical barriers to the successful development and approval of biodefense countermeasures are regulatory and political. The regulatory pathway is still unproven, and the political barrier is apparent because the government is not only the sole customer, but also the regulator, legislator, and collaborator of the biodefense industry. Radical strategies to lower the regulatory and manufacturing barriers have been proposed but still need to be implemented by the Department of Health and Human Services. This initiative suggests, however, that without significant federal funding and keen involvement, the development of biodefense countermeasures could be stumped. This dissertation proposes an alternative model where the resources and burdens are shared between the private industry, the government, and a third contractor party on standby. Additional opportunities to remove barriers include the need for federal commitment to maintain biodefense and BioShield funding, continuous improvement of federal coordination and communication, using a simplified acquisition procedure as opposed to the current approach favoring full and open competition, investment in biodefense product(s) and associated technological platforms, and the promotion of a government-industry-academia-military partnership. The alternative model enhancement to the biodefense drug model suggested in this dissertation along with BioShield can create the necessary foundation to stimulate the development of biodefense countermeasures for preparedness against potential bioterrorist attacks.

Author

• Duong, Dominique

• Biodefense
• Project Bioshield
• Development
• Orphan Drug Act
• Lessons
• Anthrax

Identifier

hdl:1920/6613

OAI identifier oai:identifier

oai:MARS:1920/6613