Homeland Security Emerging Threats Subcommittee Chairman Jim Langevin, D-R.I., and ranking member Michael McCaul, R-Texas, cited the recent cancellation of programs to develop protections against anthrax and radiation that were initiated under the 2004 Project BioShield law as indications of problems with the $5.6 billion program.
"This critical program is far too important to fail," Langevin said. "Unfortunately, since its creation, BioShield has enjoyed varying levels of success, and in recent months, there have been some fairly significant setbacks this committee is particularly concerned with."
McCaul observed that the 2001 anthrax incidents have never been solved and said BioShield "has had a rough start" because the Health and Human Services Department, which helps the Homeland Security Department implement the program, "has made what I consider missteps."
House Homeland Security Chairman Bennie Thompson, D-Miss., said "mistakes have been made" in developing and implementing the program, pointing out that BioShield has awarded contracts for vaccines or treatments only for three threats while the Centers for Disease Control has listed more than 30 agents of concern.
"We need to get this program to a state where it is procuring enough medicine and vaccines to protect the American people," Thompson said.
Implementation of the program was criticized sharply by Richard Hollis, chief executive officer of Hollis-Eden Pharmaceuticals. The firm's proposed treatment for acute radiation sickness was rejected after it invested two and a half years and $85 million to develop and test the product and, he said, had met all the requirements set out in the law.
Unless Congress forces major changes, "the BioShield program will remain fundamentally broken," Hollis said.
But a more positive view of the program was presented by James Davis, senior vice president of Human Genome Sciences, which won a contract to produce 100,000 doses of a new treatment for anthrax.
Officials from Homeland Security, HHS, the National Institutes of Health and the Food and Drug Administration conceded that there were some weaknesses in the BioShield legislation, particularly in the ability to encourage firms to invest in the frequently long and expensive development of new vaccines and medicines.
"What is still missing is a commitment by private industry to invest," said Jeffrey Runge, Homeland Security's chief medical officer.
Gerald Parker, principal deputy assistant HHS secretary for preparedness and response, insisted that progress has been made in protecting the nation from bio-terrorism, citing eight programs initiated under BioShield to improve protection against smallpox, anthrax, botulism and radiation.
Parker acknowledged the failure of Hollis' anti-radiation effort and the cancellation of a contract with VaxGen, Inc. to produce a "second-generation" anthrax vaccine. But he said the department has developed a new strategy for developing a better anthrax vaccine and is working to attract industry to produce other needed bio-terrorism defenses.
The administration officials and lawmakers all said legislation passed last year to create the Biomedical Advanced Research and Development Agency should help encourage firms to invest in bio-terrorism defenses by providing some government funding for advanced development and testing of promising new products.