Executive Briefing Series (formerly The Food & Drug Letter)

As the issue of homeland security takes on increasing urgency, the federal government is poised to issue biodefense contracts totaling in the billions of dollars, with much of that money intended for the coffers of pharmaceutical companies.

HHS has launched its biodefense initiative that calls for the acquisition of medical countermeasures against inhalation anthrax, as well as a next generation anthrax vaccine, by issuing two requests for proposals (RFPs) that fall under Project BioShield.

Sponsors of the BioShield II legislation plan to reintroduce the bill during the next session of Congress and include tax, intellectual property and liability reforms, as well as other incentives, to lure major pharmaceutical companies into signing biodefense contracts.

Indemnification from product liability lawsuits has emerged as a central issue for pharmaceutical and biotechnology companies considering entry into the biodefense arena — particularly for medical countermeasures that may be deployed in emergencies without prior FDA approval, according to industry and congressional experts.

As part of the Department of Homeland Security’s (DHS’) commitment to enhance security at the nation's key ports and facilities, the fourth round of port security grants has awarded $49,429,867 to 154 recipients across the country.

NIH’s National Institute of Allergy and Infectious Diseases has awarded a five-year, $16.9 million contract to Northrop Grumman for the development of a database that will centralize and integrate data for six pathogens that pose significant public health threats and could be used as bioterrorism agents.

HHS has chosen Washington, D.C. and 19 other cities as part of a pilot program that will provide direct assistance to increase their capacity to deliver medicines and medical supplies during a large-scale public health emergency, such as a bioterrorism attack, nuclear accident or disease outbreak.