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U.S. Senate to Consider Biodefense Legislation
The U.S. Senate during its lame-duck session is expected to consider legislation that would further promote development of countermeasures against biological terrorism, the Washington Post reported today (see GSN, June 7). The bill would create a new Health and Human Services agency to lead the work, allocate additional funds for research, and allow for payments to small companies to ensure they can continue development of drugs. The House has already approved its version of the bill, and supporters hope the Senate will do the same. “From a policy standpoint, there is nobody shooting at it,” said Senator Richard Burr (R-N.C.), a sponsor of the legislation. The legislation is meant to reanimate Project Bioshield, which was initiated 2004 with $5.6 billion to distribute to drug makers for development of vaccines and other antidotes for biological and radioactive weapons. The program has faced a variety of problems. Large pharmaceutical companies say the amount of funding available is insufficient to attract their interest, as development of one drug costs on average $800 million. Smaller companies, meanwhile, would not receive most of the government funding until the drug is ready for production, which would force them to spend their own money during the expensive “valley of death” development phase. The flagship Bioshield project has been beset by troubles. VaxGen Inc. is far behind schedule in delivering a new anthrax vaccine; its contract is in danger after the Food and Drug Administration ruled that the company is not allowed to conduct human safety tests of the drug (see GSN, Nov. 6). The legislation would allow companies to receive 5 percent of the contract value upon meeting particular milestones in drug development, the Post reported. The Senate bill sets aside $1 billion over three years for research apart from that funded by Bioshield of the National Institutes of Health. House lawmakers approved $160 million annually over two years. Work would be led by the new Biomedical Advanced Research and Development Authority. Safety concerns must be addressed as the bill is considered, said Senator Patty Murray (D-Wash.). “We need to debate compensating those who may suffer adversely from new vaccines or treatments and expand protections for high-risk populations like children, pregnant women and the elderly,” she said in a statement (
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