Reed Smith Client Alerts

On July 21, 2004 President Bush signed into law the "Project BioShield Act of 2004" (P.L. 108-276) ("Project BioShield Act" or "Act"), a biodefense initiative first proposed by the President in his 2003 State of the Union Address. The goal of this new legislation is to provide a guaranteed market for companies that develop "qualified countermeasures," which includes drugs, biological products, and devices that are determined to be a priority pursuant to the Homeland Security Act of 2002, that would otherwise have a very small, or nonexistent, market. The Act also allows the procurement and emergency use as a "security countermeasure" drugs, biological products, or devices without those items first formally qualifying for approval or licensing.