TUESDAY, JUNE 19, 2018

DHS approves BioThrax as a product for homeland security

GAITHERSBURG, Md. — Emergent BioSolutions announced Aug. 29, 2006, that the U.S. Department of Homeland Security has granted its application for designation and certification of BioThrax (Anthrax Vaccine Adsorbed) as a “qualified anti-terrorism technology” under the Support Anti-Terrorism by Fostering Effective Technology Act (SAFETY Act).

BioThrax, the only FDA-approved vaccine for the prevention of anthrax infection, is the first vaccine to be granted such SAFETY Act coverage. BioPort Corp., a subsidiary of Emergent BioSolutions, manufactures BioThrax.

Emergent BioSolutions submitted its SAFETY Act application to DHS pursuant to its 2005 contract with the Department of Health and Human Services under which HHS purchased 5 million doses of BioThrax for the Strategic National Stockpile. In May 2006, the company executed a second contract with HHS for the delivery of an additional 5 million doses of BioThrax for the SNS.

The SAFETY Act, which Congress passed as part of the Homeland Security Act of 2002, is intended to encourage the development and deployment of anti-terrorism technologies by providing certain liability protections for providers of “qualified anti-terrorism technologies” (QATTs) for claims arising out of acts of terrorism.

To obtain SAFETY Act coverage, the applicant must submit to DHS comprehensive data and materials regarding the safety, efficacy and deployment history of the technology. DHS then evaluates whether the technology meets the criteria for SAFETY Act coverage, including whether it is aimed at preventing, detecting, identifying or deterring acts of terrorism, or limiting the harm that such acts might otherwise cause, and whether it performs as intended, is safe for use, and conforms to the manufacturer’s specifications.

DHS granted BioThrax both types of protections available under the SAFETY Act: “Designation” and “Certification.” “Designation” provides the seller of a QATT with several benefits, including exclusive jurisdiction in federal court, limitation of liability to a specified amount of insurance coverage, and a bar on punitive damages. “Certification” confers status as an “Approved Product for Homeland Security” and enables the seller to invoke a rebuttable presumption that the government contractor defense applies, potentially eliminating liability for claims arising from acts of terrorism.