"Following the terrorist attacks of 2001, the federal government determined that it would need additional medical countermeasures (e.g., diagnostic tests, drugs, vaccines, and other treatments) to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents. The paucity of CBRN agent countermeasures is attributed to the lack of a significant commercial market. Because these diseases and conditions occur infrequently, little economic incentive exists to invest the millions of dollars required to bring treatments to market.[…] To encourage the development of new CBRN countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. The 108th Congress considered this proposal and passed the Project BioShield Act of 2004 (P.L. [Public Law] 108-276, signed into law July 21, 2004). This act has three main provisions. It provides the Department of Health and Human Services (HHS) expedited procedures for CBRN terrorism-related spending including procuring products, hiring experts, and awarding research grants. The act creates a government-market guarantee by allowing the HHS Secretary to obligate funds to purchase countermeasures while they still have several more years of development. However, companies only receive payment when development is complete and the product is delivered. The act also authorizes the HHS Secretary to temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval."
CRS Report for Congress, RS21507
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