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biodefense

BioShield Project Lagging

US official admits problems in BioShield program

Apr 12, 2006 (CIDRAP News) – The Bush administration acknowledged last week that its $5.6 billion program to build a supply of medical countermeasures against biological weapons and other threats is struggling and needs help, according to a newspaper report.

Alex M. Azar II, a deputy secretary in the Department of Health and Human Services (HHS), acknowledged that Project BioShield has problems and promised increased efforts to make it work, according to an Apr 7 report in the Washington Post.

Speaking to the health subcommittee of the House Committee on Energy and Commerce, Azar "conceded that the lack of a strategic plan has left industry guessing about the government's priorities," the Post reported.

The story said corporate executives warned that they need clearer direction from the program to help them decide what kind of research to launch. Executives also complained of delays, bureaucratic inertia, and other problems with the program.

Rep. Anna G. Eschoo, D-Calif., was quoted as saying, "I think what's lacking in all this is a real sense of urgency. I can't help but think we are not prepared if, God forbid, any of these catastrophes were to be visited upon the United States."

Under questioning from members of both parties, administration officials conceded many criticisms that the drug and biotechnology industry has aimed at Project BioShield in recent months, the newspaper said.

"We recognize that more can and must be done to aggressively and efficiently implement Project BioShield," Azar was quoted as saying. "We will make this process more transparent and work to educate the public and industry about our priorities and opportunities."

He promised that HHS would publish a draft plan and invite comments later this year and follow up with a final plan soon afterward. In addition, the story said, HHS Secretary Mike Leavitt has promised to reorganize the Office of Public Health Emergency Preparedness, which runs the program.

Stewart Simonson, the HHS assistant secretary in charge of that office, resigned in March. Some congress members had criticized him as lacking the scientific expertise needed for the position, the story said.

Some experts at the hearing said Project BioShield needs more personnel and increased legal authority to support risky research, the Post reported. Tara O'Toole, a University of Pittsburgh biodefense expert who works in Baltimore, estimated that HHS needs another 100 employees to manage the program efficiently. About 40 people work on the program now, the story said.

Azar reported that HHS has committed close to $1.1 billion in BioShield contracts so far. The largest project is an $877 million contract with VaxGen Inc., Brisbane, Calif., for 75 million doses of a new anthrax vaccine.

The contract, awarded in November 2004, calls for VaxGen to deliver the vaccine by November 2007. The Post said the company has conceded it is at least a year behind schedule in making the vaccine.

The BioShield program, enacted in July 2004, was designed to speed the development of drugs and vaccines to counter the effects of biological, chemical, nuclear, and radiological agents.
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