LIEBERMAN, COLLINS CITE VULNERABILITIES IN BIODEFENSE GAO REPORT OUTLINES PAST MISTAKES

WASHINGTON – Homeland Security and Governmental Affairs Committee Chairman Joe Lieberman, ID-Conn, and Ranking Member Susan Collins R-Me., Tuesday, called on the Departments of Health and Human Services and Homeland Security to exert as much effort as possible to shore up the nation’s defenses against potential bioterror attacks and naturally occurring pandemics, such as Avian Flu.At a Committee hearing examining the challenges of preventing and responding to a biological catastrophe, witnesses testified that HHS did not appear to be learning from past mistakes and HHS and DHS lacked a strategic approach and effective operational plans to protect Americans from biological catastrophes. A new Government Accountability Office report was released in conjunction with the hearing that described the failures of the Department of Health and Human Services to procure a 21st century anthrax vaccine and to prevent waste of the current vaccine the Department has stockpiled. “In its report, GAO points out that HHS has not yet fully examined its failure in trying to procure an updated anthrax vaccine, much less adopted measures to avoid a repeat of it,” Lieberman said. “We have a lot to do in the area of medical readiness. We are very fortunate that we have not experienced another attack – from biological agents or any other form of weapon of mass destruction. But that obviously doesn’t mean we will be so lucky in the future.” “This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste,” said Collins. “At the same time, the GAO discovered that taxpayers stand to lose $128 million in 2008 as stocks of the current anthrax vaccine expire unless HHS can develop a system for transferring them to DOD where they could be used. HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons.” The GAO report found that: • HHS had unrealistic expectations with respect to timeframes and manufacturing challenges required to complete the contract allowing a premature contract award. • The contractor, VaxGen, accepted excessive risk and unrealistic contract terms to complete work on the vaccine even though its product was still in the early development stages and the company did not have sufficient capital resources, experienced manufacturing staff, or production capacity to complete advanced development and production. • HHS and VaxGen underappreciated the regulatory requirements needed to meet FDA approval. GAO Chief Technologist Keith Rhodes expressed concern about the awarding of a new contract for an updated anthrax vaccine. He said HHS was in danger of repeating the mistakes it made with the VaxGen contract because it had not made a complete analysis of its mistakes regarding VaxGen. HHS said it would provide GAO with a lessons learned analysis. Witnesses also discussed the effectiveness of Biowatch, a system of censors, currently set up in over 30 U.S. cities to detect the presence of biological agents. In addition to Dr. Rhodes, witnesses included DHS Undersecretary for Science and Technology Jay Cohen, HHS Deputy Assistant Secretary for Preparedness and Response Gerald Parker, and CEO of the Center for Biosecurity Tara O’Toole